As filed with the Securities and Exchange Commission on January 11, 2024

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

_______________________

to

FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

_______________________

BLUERIVER ACQUISITION CORP.
(Exact Name of Registrant as Specified in Its Charter)

_______________________

250 West Nottingham Drive, Suite 400
San Antonio, Texas 78209
(210) 832-3305
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

_______________________

John Gregg
Randall Mays
250 West Nottingham Drive, Suite 400
San Antonio, Texas 78209
(210) 832-3305
(Name, address, including zip code, and telephone number, including area code, of agent for service)

_______________________

Copies to:

_______________________

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after this registration statement is declared effective and all other conditions to the business combination described in the enclosed proxy statement/prospectus have been satisfied or waived.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering: ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer) ☐

Exchange Act Rule 14d-l(d) (Cross-Border Third-Party Tender Offer) ☐

____________

*          Immediately prior to the consummation of the Business Combination described in the proxy statement/prospectus, BlueRiver Acquisition Corp. intends to effect a deregistration under the Cayman Islands Companies Act (As Revised) and a domestication under Section 388 of the Delaware General Corporation Law, pursuant to which the jurisdiction of incorporation for BlueRiver Acquisition Corp. will be changed from the Cayman Islands to the State of Delaware (the “Domestication”). All securities being registered will be issued by the continuing entity following the Domestication, which will be renamed “Spinal Stabilization Technologies, Inc.” in connection with the Business Combination, as further described in the proxy statement/prospectus. As used in this proxy statement/prospectus, the term “registrant” refers to BlueRiver Acquisition Corp. (a Cayman Islands exempted company) prior to the Domestication and to the Company (a Delaware corporation) following the Domestication. As used herein, the “Company” refers to BlueRiver Acquisition Corp. as a Delaware corporation by way of continuation following the Domestication and the Business Combination, which in connection with the Domestication and simultaneously with the Business Combination, will change its corporate name to “Spinal Stabilization Technologies, Inc.”

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the SEC, acting pursuant to said Section 8(a), may determine.

The information in this proxy statement/prospectus is not complete and may be changed. The registrant may not issue these securities until the registration statement filed with the Securities and Exchange Commission is effective. The proxy statement/prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

PRELIMINARY, SUBJECT TO COMPLETION, DATED JANUARY 11, 2024

PROXY STATEMENT FOR
EXTRAORDINARY GENERAL MEETING OF BLUERIVER ACQUISITION CORP.
PROSPECTUS FOR
9,860,428 SHARES OF CLASS A COMMON STOCK AND 9,850,000 WARRANTS OF
BLUERIVER ACQUISITION CORP.
(AFTER ITS DOMESTICATION AS A CORPORATION INCORPORATED IN THE STATE OF
DELAWARE, WHICH WILL BE RENAMED “SPINAL STABILIZATION TECHNOLOGIES, INC.”
IN CONNECTION WITH THE BUSINESS COMBINATION
DESCRIBED HEREIN)

The board of directors of BlueRiver Acquisition Corp., a Cayman Islands exempted company (“BlueRiver”), has approved (i) the de-registration in the Cayman Islands and the transfer by way of continuation of BlueRiver as a Delaware corporation (the “Domestication”); (ii) the acquisition of certain equity interests in Spinal Stabilization Technologies, LLC (“SST”), by BlueRiver through a merger, pursuant to which SST will become a direct subsidiary of the Company (as defined below) as a result thereof (the “Business Combination”); and (iii) the other transactions contemplated by that certain Agreement and Plan of Merger, dated as of July 21, 2023, by and among BlueRiver Acquisition Corp., BLUA Merger Sub LLC, a Texas limited liability company and wholly-owned subsidiary of BlueRiver (“Merger Sub”), and Spinal Stabilization Technologies, LLC, a Texas limited liability company (such agreement, the “Merger Agreement”) (a copy of which is attached to this proxy statement/prospectus as Annex A). As used in this proxy statement/prospectus, the “Company” refers to BlueRiver as a Delaware corporation by way of continuation following the Domestication and the Business Combination, which, in connection with the Domestication and simultaneously with the consummation of the Business Combination, will change its corporate name to “Spinal Stabilization Technologies, Inc.” We also refer to BlueRiver following the Business Combination as “Surviving Pubco.” As described in this proxy statement/prospectus, BlueRiver’s shareholders are being asked to consider a vote upon (among other things) the Business Combination.

At the effective time of the Domestication and prior to the consummation of the Business Combination, (i) the issued and outstanding Class A ordinary shares, par value $0.0001 per share (the “Class A ordinary shares”), of BlueRiver will convert automatically by operation of law, on a one-for-one basis, into shares of Class A common stock, par value $0.0001 per share, of the Company (the “Class A common stock”); (ii) the issued and outstanding redeemable Public Warrants that were registered pursuant to the Registration Statement on Form S-1 (SEC File No. 333-252050) of BlueRiver (the “IPO registration statement”) will automatically become redeemable Warrants to acquire shares of Class A common stock at an exercise price of $11.50 per share on the terms and subject to the conditions set forth in the applicable warrant agreement (no other changes will be made to the terms of any issued and outstanding public warrants as a result of the Domestication); (iii) each issued and outstanding unit of BlueRiver that has not been previously separated into the underlying Class A ordinary share and underlying warrant upon the request of the holder thereof, will be cancelled and will entitle the holder thereof to one share of Class A common stock and one-third of one redeemable warrant to acquire one share of Class A common stock at an exercise price of $11.50 per share on the terms and subject to the conditions set forth in the applicable warrant agreement; (iv) each issued and outstanding Class B ordinary share, par value $0.0001 per share (the “Class B ordinary shares”), of BlueRiver will convert automatically by operation of law, on a one-for-one basis without giving effect to any rights of adjustment or other anti-dilution protections, into one share of Class A common stock; and (v) the issued and outstanding BlueRiver Private Placement Warrants issued in a private placement in connection with BlueRiver’s initial public offering will automatically become Warrants to acquire shares of Class A common stock at an exercise price of $11.50 per share on the terms and subject to the conditions set forth in the applicable warrant agreement (no other changes will be made to the terms of any issued and outstanding Private Placement Warrants as a result of the Domestication).

Accordingly, this prospectus covers 9,860,428 shares of Class A common stock and 9,850,000 Warrants to acquire shares of Class A common stock that will be outstanding following the Business Combination. This prospectus also covers the offer of 9,850,000 shares of Class A common stock underlying Warrants that will be issued and outstanding as a result of the Business Combination. Following the Business Combination, we will be required to file and have declared effective a new registration statement that can be used for the exercise of Public Warrants and exchange of Class V Common Stock and Surviving Company Class A Common Units before such Public Warrants and Class V Common Stock and Surviving Company Class A Common Units may be exercised or exchanged as applicable.

It is anticipated that, upon completion of the Business Combination, and assuming that the Warrant Amendment is not adopted, (1) BlueRiver’s Public Shareholders will own between approximately 5.8% and none of the outstanding Class A Common Stock of the Company, (2) holders of SST membership units immediately prior to the Effective Time (the “SST Holders”) will own between approximately 74.8% and 79.4% of the Class A common stock assuming that all of the Surviving Company Class A Membership Units held prior to such exchange by the SST Holders are exchanged (together

BLUERIVER ACQUISITION CORP.

A Cayman Islands Exempted Company
(Company Number 367278)
250 West Nottingham Drive, Suite 400, San Antonio, Texas 78209

To the Shareholders and Warrant Holders of BlueRiver:

You are cordially invited to attend the extraordinary general meeting in lieu of the annual general meeting (the “Shareholders Meeting”) of BlueRiver Acquisition Corp., a Cayman Islands exempted company (“BlueRiver” and, after the Domestication as described below, the “Company”), at [•], at the offices of [•] located at [•], or via a virtual meeting, or at such other time, on such other date and at such other place to which the meeting may be adjourned.

As a warrant holder of BlueRiver, you are cordially invited to attend the meeting of warrant holders (the “Warrant Holders Meeting” and, together with the Shareholders Meeting, the “Special Meetings”) of BlueRiver, at [•], at the offices of [•] located at [•], or via a virtual meeting, or at such other time, on such other date and at such other place to which the meeting may be adjourned.

At the Shareholders Meeting, shareholders of BlueRiver will be asked to consider and vote upon the following proposals:

Proposal No. 1 — The Business Combination Proposal — a proposal, which is referred to herein as the “Business Combination Proposal,” to approve and adopt the Agreement and Plan of Merger, dated effective as of July 21, 2023 (as may be further amended or supplemented from time to time, the “Merger Agreement”), by and among BlueRiver, BLUA Merger Sub LLC (“Merger Sub”) and Spinal Stabilization Technologies, LLC (“SST”), a copy of which is attached to the accompanying proxy statement/prospectus as Annex A, and the transactions contemplated thereby. In accordance with the terms and subject to the conditions of the Merger Agreement, among other things, following the Domestication of BlueRiver to the State of Delaware as described below, BlueRiver will acquire certain equity interests of SST, by way of its wholly-owned subsidiary, Merger Sub, merging with and into SST (the “Merger”), with SST surviving the Merger and becoming a direct subsidiary of the Company as a result thereof (the “Business Combination”).

Proposal No. 2A — the Conversion Amendment Proposal — a proposal, which is referred to herein as the “Conversion Amendment Proposal” to consider and vote upon, by special resolution, to amend the current amended and restated memorandum and articles of association of BlueRiver (the “Existing Organizational Documents”) to provide that the Class B Ordinary Shares may be converted either at the time of the consummation of the initial Business Combination or at any earlier date at the option of the holders of the Class B Ordinary Shares (the “Conversion Amendment”), as described in more detail in the accompanying proxy statement/prospectus.

Proposal No. 2B — The Domestication Proposal — a proposal, which is referred to herein as the “Domestication Proposal,” to consider and vote upon a proposal by special resolution to approve the de-registration of BlueRiver as an exempted company in the Cayman Islands and its registration by way of continuation as a corporation incorporated under the laws of the State of Delaware (the “Domestication”). The Domestication will be effected immediately prior to the consummation of the Business Combination by BlueRiver filing a Certificate of Corporate Domestication and a Certificate of Incorporation with the Delaware Secretary of State and filing an application to de-register with the Registrar of Companies of the Cayman Islands. Upon the effectiveness of the Domestication, BlueRiver will become a Delaware corporation and will change its corporate name to “Spinal Stabilization Technologies, Inc.” and all outstanding securities of BlueRiver will convert to outstanding securities of the Company, as described in more detail in the accompanying proxy statement/prospectus

Proposal No. 3 — The Organizational Documents Proposals — proposals, which are referred to herein as the “Organization Documents Proposals,” to consider and vote upon, on a non-binding advisory basis, certain governance provisions in the Certificate of Incorporation, to approve the following material differences between the Existing Organizational Documents and the Certificate of Incorporation and the proposed new bylaws (the “Bylaws” and, together with the Certificate of Incorporation, the “Proposed Organizational Documents”) of the Company:

(A)    Organizational Documents Proposal 3A — An amendment to change the authorized share capital of BlueRiver from 200,000,000 Class A ordinary shares of a par value of $0.0001 per share (the “Class A ordinary shares”), 20,000,000 Class B ordinary shares of a par value of $0.0001 per share

(the “Class B ordinary shares” and, together with the Class A ordinary shares, the “ordinary shares”), and 1,000,000 preference shares of a par value of $0.0001 per share, to 250,000,000 shares of Class A common stock, par value $0.0001 per share (“Class A common stock”), 24,000,000 shares of Class V Common Stock, par value $0.0001 per share (the “Class V Common Stock”) and 10,000,000 shares of preferred stock, $0.0001 par value of the Company (this proposal is referred to herein as “Organizational Documents Proposal 3A”);

(B)    Organizational Documents Proposal 3B — An amendment to authorize the Company Board to make future issuances of any or all shares of Preferred Stock in one or more classes or series, with such terms and conditions as may be expressly determined by the Company Board and as may be permitted by the DGCL (this proposal is referred to herein as “Organizational Documents Proposal 3B”);

(C)    Organizational Documents Proposal 3C — An amendment to adopt Delaware as the exclusive forum for certain stockholder litigation (this proposal is referred to herein as “Organizational Documents Proposal 3C”); and

(D)    Organizational Documents Proposal 3D — Certain other changes in connection with the replacement of Existing Organizational Documents with the Certificate of Incorporation and Bylaws to be adopted as part of the Domestication, including (1) changing the post-Business Combination corporate name from “BlueRiver Acquisition Corp.” to “Spinal Stabilization Technologies, Inc.,” which is expected to occur after the Domestication in connection with the Business Combination, (2) making the Company’s corporate existence perpetual, (3) electing to not be governed by Section 203 of the DGCL, (4) granting an explicit waiver regarding corporate opportunities to non-officer or non-employee directors of the Company and (5) removing certain provisions related to our status as a blank check company that will no longer be applicable upon consummation of the Business Combination, all of which the board of directors of BlueRiver believes are necessary to adequately address the needs of the Company after the Business Combination (this proposal is referred to herein as “Organizational Documents Proposal 3D”).

Proposal No. 4 — The Equity Incentive Plan Proposal — a proposal, which is referred to herein as the “Equity Incentive Plan Proposal,” to consider and vote upon the approval by ordinary resolution of the Equity Incentive Plan.

Proposal No. 5 — The Charter Proposal — a proposal, which is referred to herein as the “Charter Proposal,” to consider and vote upon a proposal by special resolution, of the amendment and restatement of the Existing Organizational Documents (as defined herein) by the deletion in their entirety and the substitution in their place of the proposed new certificate of incorporation (the “Certificate of Incorporation”) of the Company (a corporation incorporated in the State of Delaware, assuming the Domestication Proposal is approved and adopted, and the filing with and acceptance by the Secretary of State of Delaware of the Certificate of Corporate Domestication in accordance with Section 388 of the Delaware General Corporation Law (the “DGCL”)), including authorization of the change in authorized share capital as indicated therein and the change of name of BlueRiver to “Spinal Stabilization Technologies, Inc.” in connection with the Business Combination.

Proposal No. 6 — The NYSE American Proposal — a proposal, which is referred to herein as the “NYSE American Proposal,” to consider and vote upon a proposal by ordinary resolution to approve, for the purposes of complying with the applicable provisions of NYSE American Listing Rules 712 and 713, the issuance of shares of Class A common stock and securities convertible into or exchangeable for Class A common stock in connection with the Business Combination.

Proposal No. 7 — The Adjournment Proposal — a proposal, which is referred to herein as the “Adjournment Proposal,” to consider and vote upon a proposal by ordinary resolution to approve the adjournment of the extraordinary general meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of one or more proposals at the extraordinary general meeting.

At the Warrant Holders Meeting, warrant holders of BlueRiver will be asked to consider and vote upon the following proposals:

Proposal No. 1 — The Warrant Amendment Proposal — a proposal, which is referred to herein as the “Warrant Amendment Proposal,” to approve and adopt the amendment to the Warrant Agreement (the “Warrant Amendment”), a copy of which is attached to the accompanying proxy statement/prospectus as Annex I, and

the transactions contemplated thereby. In accordance with the terms and subject to the conditions of the Warrant Amendment, among other things, on the Closing Date after the Domestication and before the effective time of the Merger, each of the then outstanding BlueRiver Warrants will be cancelled and exchanged for 0.075 shares of Surviving Pubco Class A Common Stock.

Proposal No. 2 — The Adjournment Proposal — a proposal, which is referred to herein as the “Warrant Holders Adjournment Proposal,” to consider and vote upon a proposal to approve the adjournment of the Warrant Holders Meeting to a later date or dates, if necessary, (a) to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of the Warrant Amendment Proposal at the Warrant Holders Meeting or (b) if the BlueRiver Board determines before the Warrant Holders Meeting that it is not necessary or no longer desirable to proceed with the proposals.

Approval of the Business Combination Proposal, the Conversion Amendment Proposal, the Domestication Proposal, the Charter Proposal and the NYSE American Proposal are conditions to closing the Business Combination. The Business Combination will be consummated only if the Business Combination Proposal, the Conversion Amendment Proposal, the Domestication Proposal, the Charter Proposal and the NYSE American Proposal (collectively, the “Condition Precedent Proposals”) are approved at the Shareholders Meeting, or otherwise waived by the party for whose benefit such condition exists. Each of the Condition Precedent Proposals is cross-conditioned on the approval of each other.

In addition, you will be asked to consider and vote upon the Organizational Documents Proposals, the Equity Incentive Plan Proposal and the Adjournment Proposal. None of the Organizational Documents Proposals, the Equity Incentive Plan Proposal or the Adjournment Proposal is conditioned upon the approval of any other proposal. Each of these proposals is more fully described in the accompanying proxy statement/prospectus, which each shareholder is encouraged to read carefully in its entirety.

At the effective time of the Domestication and prior to the consummation of the Business Combination, (i) the issued and outstanding Class A ordinary shares, par value $0.0001 per share (the “Class A ordinary shares”), of BlueRiver will convert automatically by operation of law, on a one-for-one basis, into shares of Class A common stock, par value $0.0001 per share, of the Company (the “Class A common stock”); (ii) the issued and outstanding redeemable warrants that were registered pursuant to the Registration Statement on Form S-1 (SEC File No. 333-252050) of BlueRiver (the “IPO registration statement”) will automatically become redeemable warrants to acquire shares of Class A common stock at an exercise price of $11.50 per share on the terms and subject to the conditions set forth in the applicable warrant agreement (no other changes will be made to the terms of any issued and outstanding public warrants as a result of the Domestication); (iii) each issued and outstanding Class B ordinary share, par value $0.0001 per share (the “Class B ordinary shares”), of BlueRiver will convert automatically by operation of law, on a one-for-one basis without giving effect to any rights of adjustment or other anti-dilution protections, into one share of Class A common stock and (iv) the issued and outstanding warrants of BlueRiver issued in a private placement will automatically become warrants to acquire shares of Class A common stock at an exercise price of $11.50 per share on the terms and subject to the conditions set forth in the applicable warrant agreement (no other changes will be made to the terms of any issued and outstanding private placement warrants as a result of the Domestication). As used herein, “Public Shares” shall mean the Class A ordinary shares and “Public Warrants” shall mean the redeemable warrants to acquire Class A ordinary shares, in each case, that were registered pursuant to the IPO registration statement and the shares of the Class A common stock issued as a matter of law upon the conversion thereof at the effective time of the Domestication. For further details, see “Proposal 2B: The Domestication Proposal.”

In accordance with the terms and subject to the conditions of the Merger Agreement, at the Effective Time, (i) holders of SST membership units immediately prior to the Effective Time (the “SST Holders”) will (a) retain up to an aggregate of [•] Surviving Company Class A Membership Units, which are non-voting economic interests in SST and (b) receive an equal number of shares of Class V Common Stock, which will be non-economic voting interests in the Company and (ii) assuming no Redemptions, existing stockholders of BlueRiver will retain [•] shares of Class A common stock, and the Company will hold [•] Surviving Company Class A Membership Units, and (iii) BlueRiver will contribute the Available Cash to the Surviving Company. For further details, see “Proposal 1: The Business Combination Proposal — The Merger Agreement — Business Combination Consideration.”

Concurrently with the execution of the Merger Agreement, BlueRiver, SST and the Sponsor Parties entered into the Sponsor Letter Support Agreement on July 21, 2023 (the “Sponsor Letter Agreement”), pursuant to which, among other things, the Sponsor Parties have agreed to (i) vote in favor of the Merger Agreement and the transactions contemplated thereby, (ii) waive any adjustment to the conversion ratio set forth in the Existing Organizational Documents of BlueRiver, (iii) be bound by certain other covenants and agreements related to the Business Combination and (iv) be bound by certain transfer restrictions with respect to his, her or its shares in BlueRiver prior to the closing of the Business Combination (the date on which such closing occurs, the “Closing Date”), or the earlier termination of the Merger Agreement. For further details, see “Proposal 1: The Business Combination Proposal — The Merger Agreement — Business Combination Consideration.”

Concurrently or promptly after the signing of the Merger Agreement, James Douglas Lutz, MD Dynasty, Leland Lutz Trust, Anne de Compiegne Lutz, SSTIG, The De Compiegne Property Company No. 20, LTD., Twenty S-5, LLC, SFSST LLC, SFSST (OFFSHORE) LLC, LLM Family Investments Series 44, L.P., RTM Partners, LTD. and Dakaros II (collectively, the “Specified SST Members”) entered into a Member Support Agreement (the “Member Support Agreements”) with BlueRiver and SST, pursuant to which the Specified SST Members have agreed to (i) vote in favor of the Merger Agreement and the transactions contemplated thereby, (ii) irrevocably appoint BlueRiver or any individual designated by BlueRiver as such Equityholder’s agent, attorney-in-fact and proxy (with Specified SST Members power of substitution and resubstitution) to attend on behalf of such Equityholder any meeting of the Specified SST Members with respect to the Business Combination, and to vote (or cause to be voted) the units of the SST held by such SST Unitholder or consent (or withhold consent) with respect to the Merger Agreement and the transactions contemplated thereby and (iii) be bound by certain other covenants and agreements related to the Business Combination. See “Proposal 1: The Business Combination Proposal — Certain Agreements Related to the Business Combination” in the accompanying proxy statement/prospectus for more information.

Pursuant to the Existing Organizational Documents, a public shareholder may request that BlueRiver redeem all or a portion of such shareholder’s Public Shares for cash if the Business Combination is consummated. Holders of units must elect to separate the units into the underlying Public Shares and Public Warrants prior to exercising redemption rights with respect to the Public Shares. If holders hold their units in an account at a brokerage firm or bank, holders must notify their broker or bank that they elect to separate the units into the underlying Public Shares and Public Warrants, or if a holder holds units registered in its own name, the holder must contact Continental Stock Transfer & Trust Company (the “Transfer Agent”), BlueRiver’ transfer agent, directly and instruct it to do so. The redemption rights include the requirement that a holder must identify itself in writing as a beneficial holder and provide its legal name, phone number and address to the Transfer Agent in order to validly redeem its shares. Public shareholders may elect to redeem their Public Shares even if they vote “for” the Business Combination Proposal. If the Business Combination is not consummated, the Public Shares will be returned to the respective holder, broker or bank. If the Business Combination is consummated, and if a public shareholder properly exercises its right to redeem all or a portion of the Public Shares that it holds and timely delivers its shares to the Transfer Agent, the Company will redeem such Public Shares for a per-share price, payable in cash, equal to the pro rata portion of the BlueRiver’ trust account established at the consummation of BlueRiver IPO (the “Trust Account”), calculated as of two business days prior to the consummation of the Business Combination. For illustrative purposes, as of [•], 2024, this would have amounted to approximately $[•] per issued and outstanding Public Share. If a public shareholder exercises its redemption rights in full, then it will be electing to exchange its Public Shares for cash and will no longer own Public Shares. The redemption takes place immediately following the Domestication. See “Shareholders Meeting — Redemption Rights” in the accompanying proxy statement/prospectus for a detailed description of the procedures to be followed if you wish to redeem your Public Shares for cash.

Notwithstanding the foregoing, a public shareholder, together with any affiliate of such public shareholder or any other person with whom such public shareholder is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Securities Exchange Act of 1934, as amended (“Exchange Act”)), will be restricted from redeeming its Public Shares with respect to more than an aggregate of 15% of the Public Shares. Accordingly, if a public shareholder, alone or acting in concert or as a group, seeks to redeem more than 15% of the Public Shares, then any such shares in excess of that 15% limit would not be redeemed for cash.

The holders of Class B ordinary shares have agreed to vote all of their ordinary shares in favor of the proposals being presented at the Shareholders Meeting and waive their redemption rights with respect to such ordinary shares in connection with the consummation of the Business Combination. The Class B ordinary shares will be excluded

from the pro rata calculation used to determine the per-share redemption price. As of the date of the accompanying proxy statement/prospectus, the holders of Class B ordinary shares own approximately 20% of the issued and outstanding ordinary shares.

The Merger Agreement provides that the obligations of SST to consummate the Business Combination are conditioned on, among other things, that (x) the aggregate amount of cash proceeds available for release to BlueRiver from the Trust Account and (y) the net amount of proceeds actually received by BlueRiver pursuant to any PIPE Financing consummated prior to, or in connection with, the Closing, less the aggregate amount of fees and expenses payable by BlueRiver in connection with the Business Combination and the transactions contemplated thereby that remain unpaid immediately prior to the Closing, shall be at least $10,000,000 (the “Minimum Cash Condition”). If this Minimum Cash Condition is not met, and such condition is not duly waived by SST, then the Merger Agreement could be terminated and the proposed Business Combination may not be consummated. The Merger Agreement is also subject to the satisfaction or waiver of certain other closing conditions as described in the accompanying proxy statement/prospectus. There can be no assurance that the parties to the Merger Agreement would waive any such provision of the Merger Agreement. In addition, the Merger Agreement provides that the obligations of SST and BlueRiver to consummate the Business Combination are conditioned on, among other things, BlueRiver having, after giving effect to the Business Combination and the transactions contemplated thereby, net tangible assets (as determined in accordance with Rule 3a51-1(g)(1) of the Exchange Act) of at least $5,000,001.

BlueRiver is providing the accompanying shareholder proxy statement/prospectus and accompanying proxy card to BlueRiver’ shareholders in connection with the solicitation of proxies to be voted at the Shareholders Meeting, warrant proxy card to BlueRiver warrant holders in connection with the solicitation of proxies to be voted at the Warrant Holders Meeting and at any adjournments of the extraordinary meeting. Information about the Shareholders Meeting, the Warrant Holders Meeting, the Business Combination and other related business to be considered by BlueRiver’s shareholders at the Shareholders Meeting and BlueRiver’s warrant holdres at the Warrant Holders Meeting is included in the accompanying proxy statement/prospectus. Whether or not you plan to attend the Shareholders Meeting, all of BlueRiver’s shareholders are urged to read the accompanying proxy statement/prospectus, including the Annexes and other documents referred to therein, carefully and in their entirety. You should also carefully consider the risk factors described in “Risk Factors” beginning on page 30 of the accompanying proxy statement/prospectus.

After careful consideration, the board of directors of BlueRiver has approved the Business Combination and unanimously recommends that shareholders vote “FOR” the adoption of the Merger Agreement and approval of the transactions contemplated thereby, including the Business Combination, and “FOR” all other proposals presented to BlueRiver’s shareholders in the accompanying proxy statement/prospectus. Further, the board of directors of BlueRiver has approved the Warrant Amendment and unanimously recommends that the warrant holders vote “FOR” the adoption of the Warrant Amendment and “FOR” all other proposals presented to BlueRiver’s warrant holders in the accompanying proxy statement/prospectus. When you consider the recommendation of these proposals by the board of directors of BlueRiver, you should keep in mind that BlueRiver’s directors and officers have interests in the Business Combination that may conflict with your interests as a shareholder or a warrant holder, as applicable. See the section entitled “Proposal 1: The Business Combination Proposal — Interests of BlueRiver’s Directors and Officers and Others in the Business Combination” in the accompanying proxy statement/prospectus for a further discussion of these considerations.

The Business Combination Proposal, the Equity Incentive Plan Proposal, the NYSE American Proposal and the Adjournment Proposal will require an ordinary resolution as a matter of Cayman Islands law, being the affirmative vote of the holders of a majority, as of the Record Date (as defined in the accompanying proxy statement/prospectus), of the BlueRiver Ordinary Shares that are present and vote at the Shareholders Meeting. The Organizational Documents Proposals are voted upon on a non-binding advisory basis only. The Conversion Amendment Proposal, the Domestication Proposal and the Charter Proposal will require a special resolution as a matter of Cayman Islands law, being the affirmative vote of the holders of a majority of at least two-thirds, as of the Record Date, of the BlueRiver Ordinary Shares that are present and vote at the Shareholders Meeting. If any of the Conversion Amendment Proposal, the Domestication Proposal, the Business Combination Proposal the Charter Proposal or the NYSE American Proposal fail to receive the required approval by the shareholders of BlueRiver at the Shareholders Meeting, the Business Combination will not be completed.

The Warrant Amendment Proposal will require the affirmative vote of the holders of at least (i) 65% of the outstanding Public Warrants and (ii) 50% of the outstanding Private Placement Warrants, each voting separately as a class. Approval of the Warrant Holders Adjournment Proposal requires the affirmative vote of the holders of at least 50% of the Warrants present in person, online or represented by proxy at the Warrant Holders Meeting, with such votes cast by BlueRiver warrant holders present or represented by proxy and entitled to vote at the Warrant Holders Meeting.

Your vote is very important.    Whether or not you plan to attend the Special Meetings, please vote as soon as possible by following the instructions in the accompanying proxy statement/prospectus to make sure that your shares and/or warrants are represented at the Special Meetings. If you hold your shares in “street name” through a bank, broker or other nominee, you will need to follow the instructions provided to you by your bank, broker or other nominee to ensure that your shares and/or warrants are represented and voted at the Special Meetings. The transactions contemplated by the Merger Agreement will be consummated only if the Condition Precedent Proposals are approved at the Shareholders Meeting. Each of the Condition Precedent Proposals is cross-conditioned on the approval of each other. None of the Organizational Documents Proposals, which will be voted upon a non-binding advisory basis only, the Equity Incentive Plan Proposal, the Adjournment Proposal or the Warrant Holder Proposals is conditioned on the approval of any other proposal set forth in the accompanying proxy statement/prospectus.

If you sign, date and return your shareholder proxy card without indicating how you wish to vote, your proxy will be voted FOR each of the proposals presented at the Shareholders Meeting. If you fail to return your proxy card or fail to instruct your bank, broker or other nominee how to vote, and do not attend the Shareholders Meeting in person, the effect will be, among other things, that your shares will not be counted for purposes of determining whether a quorum is present at the Shareholders Meeting. If you are a shareholder of record and you attend the Shareholders Meeting and wish to vote in person, you may withdraw your proxy and vote in person.

If you sign, date and return your warrant holder proxy card without indicating how you wish to vote, your proxy will be voted FOR each of the proposals presented at the Warrant Holders Meeting. If you fail to return your proxy card or fail to instruct your bank, broker or other nominee how to vote, and do not attend the Warrant Holders Meeting in person, the effect will be, among other things, that your warrants will not be counted for purposes of determining whether a quorum is present at the Warrant Holders Meeting. If you are a warrant holder of record and you attend the Warrant Holders Meeting and wish to vote in person, you may withdraw your proxy and vote in person.

TO EXERCISE YOUR REDEMPTION RIGHT, YOU MUST DEMAND IN WRITING THAT YOUR PUBLIC SHARES ARE REDEEMED FOR A PRO RATA PORTION OF THE FUNDS HELD IN THE TRUST ACCOUNT AND TENDER YOUR SHARES TO BLUERIVER’S TRANSFER AGENT AT LEAST TWO BUSINESS DAYS PRIOR TO THE VOTE AT THE SHAREHOLDERS MEETING. IN ORDER TO EXERCISE YOUR REDEMPTION RIGHT, YOU NEED TO IDENTIFY YOURSELF AS A BENEFICIAL HOLDER AND PROVIDE YOUR LEGAL NAME, PHONE NUMBER AND ADDRESS IN YOUR WRITTEN DEMAND. YOU MAY TENDER YOUR SHARES BY EITHER DELIVERING YOUR SHARE CERTIFICATES (IF ANY) AND OTHER REDEMPTION FORMS TO THE TRANSFER AGENT OR BY DELIVERING YOUR SHARES ELECTRONICALLY USING THE DEPOSITORY TRUST COMPANY’S DWAC (DEPOSIT WITHDRAWAL AT CUSTODIAN) SYSTEM. IF THE BUSINESS COMBINATION IS NOT COMPLETED, THEN THESE SHARES WILL BE RETURNED TO YOU OR YOUR ACCOUNT. IF YOU HOLD THE SHARES IN STREET NAME, YOU WILL NEED TO INSTRUCT THE ACCOUNT EXECUTIVE AT YOUR BANK OR BROKER TO WITHDRAW THE SHARES FROM YOUR ACCOUNT IN ORDER TO EXERCISE YOUR REDEMPTION RIGHT.

On behalf of the board of directors of BlueRiver, I would like to thank you for your support and look forward to the successful completion of the Business Combination.

Sincerely,

John Gregg and Randall Mays
Co-Chief Executive Officers and Co-Chairmen

This proxy statement/prospectus provides shareholders and warrant holders of BlueRiver with detailed information about the Business Combination and other matters to be considered at the extraordinary general meeting of BlueRiver. We encourage you to read this entire document, including the annexes and other documents referred to herein, carefully and in their entirety. You should also carefully consider the risk factors described in the section entitled “Risk Factors” beginning on page 30 of this proxy statement/prospectus.

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES REGULATORY AGENCY HAS APPROVED OR DISAPPROVED OF THE TRANSACTIONS DESCRIBED IN THIS PROXY STATEMENT/PROSPECTUS, PASSED UPON THE MERITS OR FAIRNESS OF THE BUSINESS COMBINATION OR RELATED TRANSACTIONS, OR PASSED UPON THE ADEQUACY OR ACCURACY OF THE DISCLOSURE IN THIS PROXY STATEMENT/PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY CONSTITUTES A CRIMINAL OFFENSE.

This proxy statement/prospectus is dated [•], 2024, and is first being mailed to BlueRiver’s shareholders and warrant holders on or about [•], 2024.

NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS

BLUERIVER ACQUISITION CORP.

A Cayman Islands Exempted Company
(Company Number 367278)
250 West Nottingham Drive, Suite 400, San Antonio, Texas 78209

TO THE SHAREHOLDERS OF BLUERIVER ACQUISITION CORP.:

NOTICE IS HEREBY GIVEN that an extraordinary general meeting in lieu of the annual general meeting (the “Shareholders Meeting”) of BlueRiver Acquisition Corp., a Cayman Islands exempted company (“BlueRiver” and, after the Domestication as described below, the “Company”), will be held at [•], Eastern Time, on [•], 2024, at the offices of [•] located at [•], or via a virtual meeting, or at such other time, on such other date and at such other place to which the meeting may be adjourned.

You are cordially invited to attend the Shareholders Meeting, which will be held for the following purposes:

1.      Proposal No. 1 — The Business Combination Proposal — to consider and vote upon, as an ordinary resolution, a proposal to approve and authorize the Agreement and Plan of Merger, dated as of July 21, 2023, by and among BlueRiver Acquisition Corp. (“BlueRiver”), BLUA Merger Sub LLC, a Texas limited liability company and wholly-owned subsidiary of BlueRiver (“Merger Sub”), and Spinal Stabilization Technologies, LLC, a Texas limited liability company (the “SST”) (such agreement, the “Merger Agreement”), a copy of which is attached to this proxy statement/prospectus as Annex A, and the transactions contemplated therein, including the business combination whereby (i) BlueRiver will de-register as an exempted company in the Cayman Islands and transfer by way of continuation as a Delaware corporation (the “Domestication”) and (ii) on the Closing Date, following the Domestication, Merger Sub will merge with and into SST (the “Merger” and together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”) with SST continuing as the surviving entity of the Merger and a subsidiary of BlueRiver (the “Surviving Company”) (the “Business Combination Proposal”);

2.      Proposal No. 2A — the Conversion Amendment Proposal — to consider and vote upon a proposal, by special resolution, to amend the Existing Organizational Documents to provide that the Class B Ordinary Shares may be converted either at the time of the consummation of the initial Business Combination or at any earlier date at the option of the holders of the Class B Ordinary Shares, as described in more detail in the accompanying proxy statement/prospectus (the “Conversion Amendment Proposal”).

3.      Proposal No. 2B — The Domestication Proposal — to consider and vote upon a proposal, by special resolution, to approve the de-registration of BlueRiver as an exempted company in the Cayman Islands and its registration by way of continuation as a corporation incorporated under the laws of the State of Delaware. The Domestication will be effected immediately prior to the consummation of the Business Combination by BlueRiver filing a Certificate of Corporate Domestication and a Certificate of Incorporation with the Delaware Secretary of State and filing an application to de-register with the Registrar of Companies of the Cayman Islands. Upon the effectiveness of the Domestication, BlueRiver will become a Delaware corporation and will change its corporate name to “Spinal Stabilization Technologies, Inc.” and all outstanding securities of BlueRiver will convert to outstanding securities of the Company, as described in more detail in the accompanying proxy statement/prospectus (the “Domestication Proposal”).

4.      Proposal No. 3 — The Organizational Documents Proposals — to consider and vote upon, on a non-binding advisory basis, certain governance provisions in the Certificate of Incorporation (collectively, the “Organizational Documents Proposals”), to approve the following material differences between the current amended and restated memorandum and articles of association of

BlueRiver (the “Existing Organizational Documents”) and the Certificate of Incorporation and the proposed new bylaws (the “Bylaws” and, together with the Certificate of Incorporation, the “Proposed Organizational Documents”) of the Company:

(A)    Organizational Documents Proposal 3A — An amendment to change the authorized capital stock of BlueRiver from 200,000,000 Class A ordinary shares, par value $0.0001 per share (the “Class A ordinary shares”), 20,000,000 Class B ordinary shares, par value $0.0001 per share (the “Class B ordinary shares” and, together with the Class A ordinary shares, the “ordinary shares”), and 1,000,000 preference shares, par value $0.0001 per share, to 250,000,000 shares of Class A common stock, par value $0.0001 per share (“Class A common stock”), 24,000,000 shares of Class V Common Stock, par value $0.0001 per share (the “Class V Common Stock”) and 10,000,000 shares of preferred stock, $0.0001 par value of the Company (this proposal is referred to herein as “Organizational Documents Proposal 3A”);

(B)    Organizational Documents Proposal 3B — An amendment to authorize the Company Board to make future issuances of any or all shares of Preferred Stock in one or more classes or series, with such terms and conditions as may be expressly determined by the Company Board and as may be permitted by the DGCL (this proposal is referred to herein as “Organizational Documents Proposal 3B”);

(C)    Organizational Documents Proposal 3C — An amendment to adopt Delaware as the exclusive forum for certain stockholder litigation (this proposal is referred to herein as “Organizational Documents Proposal 3C”); and

(D)    Organizational Documents Proposal 3D — Certain other changes in connection with the replacement of Existing Organizational Documents with the Certificate of Incorporation and Bylaws to be adopted as part of the Domestication, including (1) changing the post-Business Combination corporate name from “BlueRiver Acquisition Corp.” to “Spinal Stabilization Technologies, Inc.,” which is expected to occur after the Domestication in connection with the Business Combination, (2) making the Company’s corporate existence perpetual, (3) electing to not be governed by Section 203 of the DGCL, (4) granting an explicit waiver regarding corporate opportunities to non-officer or non-employee directors of the Company and (5) removing certain provisions related to our status as a blank check company that will no longer be applicable upon consummation of the Business Combination, all of which the board of directors of BlueRiver believes are necessary to adequately address the needs of the Company after the Business Combination (this proposal is referred to herein as “Organizational Documents Proposal 3D”).

5.      Proposal No. 4 — The Equity Incentive Plan Proposal — to consider and vote upon the approval by ordinary resolution of the Equity Incentive Plan (the “Equity Incentive Plan Proposal”).

6.      Proposal No. 5 — The Charter Proposal — to consider and vote upon a proposal by special resolution, the amendment and restatement of the Existing Organizational Documents (as defined herein) by the deletion in their entirety and the substitution in their place of the proposed new certificate of incorporation (the “Certificate of Incorporation”) of the Company (a corporation incorporated in the State of Delaware, assuming the Domestication Proposal is approved and adopted, and the filing with and acceptance by the Secretary of State of Delaware of the Certificate of Corporate Domestication in accordance with Section 388 of the Delaware General Corporation Law (the “DGCL”)), including authorization of the change in authorized share capital as indicated therein and the change of name of BlueRiver to “Spinal Stabilization Technologies, Inc.” in connection with the Business Combination (the “Charter Proposal”).

7.      Proposal No. 6 — The NYSE American Proposal — to consider and vote upon a proposal by ordinary resolution to approve, for the purposes of complying with the applicable provisions of NYSE American Listing Rules 712 and 713, the issuance of shares of Class A common stock and securities convertible into or exchangeable for Class A common stock in connection with the Business Combination (the “NYSE American Proposal”).

8.      Proposal No. 7 — The Adjournment Proposal — to consider and vote upon a proposal by ordinary resolution to approve the adjournment of the extraordinary general meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of one or more proposals at the extraordinary general meeting (this proposal is referred to herein as the “Adjournment Proposal”).

These Shareholder Proposals are described in the accompanying proxy statement/prospectus, which we encourage you to read in its entirety before voting. Only holders of record of ordinary shares of BlueRiver at the close of business on [•], 2024 (the “Record Date”) are entitled to notice of the Shareholders Meeting and to vote and have their votes counted at the Shareholders Meeting and any adjournments of the Shareholders Meeting.

After careful consideration, the board of directors of BlueRiver has determined that the Shareholder Proposals are fair to and in the best interests of BlueRiver and its shareholders and unanimously recommends that the holders of BlueRiver Ordinary Shares entitled to vote with respect to each of the Shareholder Proposals, vote or give instruction to vote “FOR” the Business Combination Proposal, “FOR” the Conversion Amendment Proposal, “FOR” the Domestication Proposal, “FOR” the Equity Incentive Plan Proposal, “FOR” the Charter Proposal, “FOR” each of the Organizational Documents Proposals, “FOR” the NYSE American Proposal and “FOR” the Adjournment Proposal.

The existence of any financial and personal interests of one or more of BlueRiver’s directors may result in a conflict of interest on the part of such director(s) between what he, she or they may believe is in the best interests of BlueRiver and its shareholders and what he, she or they may believe is best for himself, herself or themselves in determining to recommend that shareholders vote for the Shareholder Proposals. See the section entitled “Shareholder Proposal 1: The Business Combination Proposal — Interests of BlueRiver’s Directors and Officers and Others in the Business Combination” in the accompanying proxy statement/prospectus for a further discussion of these considerations.

Pursuant to the Existing Organizational Documents, a Public Shareholder may request that BlueRiver redeem all or a portion of its Public Shares for cash if the Business Combination is consummated. As a holder of Public Shares, you will be entitled to receive cash for any Public Shares to be redeemed only if you:

(i)     (a) hold Public Shares, or (b) hold Public Shares through units, you elect to separate your units into the underlying Public Shares and warrants prior to exercising your redemption rights with respect to the Public Shares;

(ii)    submit a written request to Continental Stock Transfer & Trust Company (“CST”), BlueRiver’s transfer agent, in which you (a) request that BlueRiver redeem all or a portion of your Public Shares for cash, and (b) identify yourself as the beneficial holder of the Public Shares and provide your legal name, phone number and address; and

(iii)   deliver your Public Shares to CST, BlueRiver’s transfer agent, physically or electronically through The Depository Trust Company (“DTC”).

Public Shareholders may seek to have their Public Shares redeemed by BlueRiver, regardless of whether they vote for or against the Business Combination Proposal or any other Shareholder Proposal and whether they held BlueRiver Ordinary Shares as of the Record Date or acquired them after the Record Date. Any Public Shareholder who holds ordinary shares of BlueRiver on or before [•], 2024 (two (2) business days before the Shareholders Meeting) will have the right to demand that his, her or its shares be redeemed for a pro rata share of the aggregate amount then on deposit in the Trust Account, less any taxes then due but not yet paid. For illustrative purposes, based on funds in the Trust Account of approximately $[•] million on September 30, 2023 and including anticipated additional interest through the closing of the Business Combination (assuming interest accrues at recent rates and no additional tax payments are made out of the Trust Account), the estimated per share redemption price is expected to be approximately $[•]. A Public Shareholder who has properly tendered his, her or its Public Shares for Redemption will be entitled to receive his, her or its pro rata portion of the aggregate amount then on deposit in the Trust Account in cash for such shares only if the Business Combination is completed. If the Business Combination is not completed, the Redemptions will be cancelled and the tendered shares will be returned to the relevant Public Shareholders as appropriate.

BlueRiver shareholders who seek to redeem their Public Shares must demand Redemption no later than 5:00 p.m., Eastern Time, on [•], 2024 (two (2) business days before the Shareholders Meeting) by (a) submitting a written request to the Transfer Agent that BlueRiver redeem such holder’s Public Shares for cash, (b) affirmatively certifying in such request to the Transfer Agent for Redemption if such holder is acting in concert or as a “group” (as defined in Section 13 d-3 of the Exchange Act) with any other shareholder with respect to ordinary shares of BlueRiver and (c) delivering their ordinary shares, either physically or electronically using DTC’s deposit/withdrawal at custodian system (“DWAC”), at the holder’s option, to the Transfer Agent prior to the Shareholders Meeting. If you hold the shares in street name, you will have to coordinate with your broker to have your shares certificated or delivered electronically. Certificates that have not been tendered to the Transfer Agent (either physically or electronically) in accordance with these procedures will not be redeemed for cash. There is a nominal cost associated with this tendering process and the act of certificating the shares or delivering them through the DWAC system. The Transfer Agent will typically charge the tendering broker a nominal fee and it would be up to the broker whether or not to pass this cost on to the redeeming shareholder. In the event the Business Combination is not completed, this may result in an additional cost to shareholders for the return of their shares.

Notwithstanding the foregoing, a Public Shareholder, together with any affiliate of his, her, its or any other person with whom he, she or it is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Exchange Act) will be restricted from seeking Redemption Rights with respect to 15% or more of BlueRiver’ Public Shares. Accordingly, any shares held by a Public Shareholder or “group” in excess of such 15% cap will not be redeemed by BlueRiver.

Pursuant to the Sponsor Letter Agreement, the Sponsor, officers and directors of BlueRiver have waived all of their Redemption Rights and will not have Redemption Rights with respect to any BlueRiver Shares owned by them, directly or indirectly. Holders of the warrants will not have redemption rights with respect to the warrants.

Each of the Domestication Proposal, the Business Combination Proposal, the Charter Proposal, and the NYSE American Proposal is interdependent upon the others and must be approved in order for BlueRiver to complete the Business Combination contemplated by the Merger Agreement. If any of the Domestication Proposal, Business Combination Proposal, the Charter Proposal, or the NYSE American Proposal fails to receive the required approval by the shareholders of BlueRiver at the Shareholders Meeting, the Business Combination will not be completed. The Business Combination Proposal, the Equity Incentive Plan Proposal, the NYSE American Proposal and the Adjournment Proposal will require an ordinary resolution, being the approval of the holders of a majority of the ordinary shares, as of the Record Date, of the ordinary shares of BlueRiver that are present and vote at the Shareholders Meeting. The Organizational Documents Proposals are voted upon on a non-binding advisory basis only. The Domestication Proposal and the Charter Proposal will require a special resolution, being the approval of the holders of a majority of at least two-thirds, as of the Record Date, of the ordinary shares of BlueRiver that are present and vote at the Shareholders Meeting.

All shareholders of BlueRiver are cordially invited to attend the Shareholders Meeting in person. To ensure your representation at the Shareholders Meeting, however, you are urged to mark, sign and date the enclosed proxy card and return it as soon as possible in the pre-addressed postage paid envelope provided. If you are a shareholder of record of BlueRiver Ordinary Shares, you may also cast your vote in person at the Shareholders Meeting. If your shares are held in an account at a brokerage firm or bank, or by a nominee, you must instruct your broker, bank or nominee on how to vote your shares or, if you wish to attend the Shareholders Meeting and vote in person, obtain a proxy from your broker, bank or nominee.

Whether or not you plan to attend the Shareholders Meeting, we urge you to read the accompanying proxy statement/prospectus (and any documents incorporated into the accompanying proxy statement/prospectus by reference) carefully. Please pay particular attention to the section entitled “Risk Factors” in the accompanying proxy statement/prospectus.

These Warrant Holder Proposals are described in the accompanying proxy statement/prospectus, which we encourage you to read in its entirety before voting. Only holders of record of warrants of BlueRiver at the close of business on [•], 2024 (the “Record Date”) are entitled to notice of the Warrant Holder Meeting and to vote and have their votes counted at the Warrant Holder Meeting and any adjournments of the Warrant Holder Meeting.

After careful consideration, the board of directors of BlueRiver has determined that the Warrant Holder Proposals are fair to and in the best interests of BlueRiver and its warrant holders and unanimously recommends that the holders of BlueRiver Warrants entitled to vote with respect to each of the Warrant Holder Proposals, vote or give instruction to vote “FOR” the Warrant Amendment Proposal and “FOR” the Warrant Holders Adjournment Proposal.

The existence of any financial and personal interests of one or more of BlueRiver’s directors may result in a conflict of interest on the part of such director(s) between what he, she or they may believe is in the best interests of BlueRiver and its warrant holders and what he, she or they may believe is best for himself, herself or themselves in determining to recommend that warrant holders vote for the Warrant Holder Proposals. See the section entitled “Warrant Holder Proposal 1: The Warrant Amendment Proposal” in the accompanying proxy statement/prospectus for a further discussion of these considerations.

All warrant holders of BlueRiver are cordially invited to attend the Warrant Holders Meeting in person. To ensure your representation at the Warrant Holders Meeting, however, you are urged to mark, sign and date the enclosed proxy card and return it as soon as possible in the pre-addressed postage paid envelope provided. If you are a warrant holder of record of BlueRiver Warrants, you may also cast your vote in person at the Warrant Holders Meeting. If your shares are held in an account at a brokerage firm or bank, or by a nominee, you must instruct your broker, bank or nominee on how to vote your shares or, if you wish to attend the Warrant Holders Meeting and vote in person, obtain a proxy from your broker, bank or nominee.

Whether or not you plan to attend the Warrant Holders Meeting, we urge you to read the accompanying proxy statement/prospectus (and any documents incorporated into the accompanying proxy statement/prospectus by reference) carefully. Please pay particular attention to the section entitled “Risk Factors” in the accompanying proxy statement/prospectus.

Your vote is important regardless of the number of warrants you own.    Whether you plan to attend the Warrant Holders Meeting or not, please mark, sign and date the enclosed proxy card and return it as soon as possible in the envelope provided. If your shares are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares you beneficially own are properly counted.

Thank you for your participation. We look forward to your continued support.

By Order of the Board of Directors

[•], 2024

TABLE OF CONTENTS

ABOUT THIS PROXY STATEMENT/PROSPECTUS

This document, which forms part of a registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission (the “SEC”) by BlueRiver Acquisition Corp. (“BlueRiver” or “SPAC”) (File No. 333-274908) (the “Registration Statement”), constitutes a prospectus of BlueRiver under Section 5 of the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of Class A common stock of the Company and warrants to purchase Class A common stock that will be issued if the Business Combination described below is consummated. This document also constitutes a notice of meeting and a proxy statement under Section 14(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with respect to (i) the extraordinary general meeting of BlueRiver at which BlueRiver shareholders will be asked to consider and vote upon the proposals to adopt the Business Combination Proposal (as described below), to adopt the Conversion Amendment Proposal (as described below), to adopt the Domestication Proposal (as described below), to adopt the Organizational Documents Proposals (as described below), to adopt the Equity Incentive Plan Proposal (as described below), to adopt the NYSE American Proposal (as described below) and, if necessary, to adopt the Adjournment Proposal (as described below), and (ii) the meeting of BlueRiver at which BlueRiver warrant holders will be asked to consider and vote upon the Warrant Amendment Proposal (as described below) and, if necessary, the Warrant Holders Adjournment Proposal (as described below).

At the Shareholders Meeting, shareholders of BlueRiver will be asked to consider and vote upon the following proposals:

1.      Proposal No. 1 — The Business Combination Proposal — to consider and vote upon, as an ordinary resolution, a proposal to approve and authorize the Agreement and Plan of Merger, dated as of July 21, 2023, by and among BlueRiver Acquisition Corp. (“BlueRiver”), BLUA Merger Sub LLC, a Texas limited liability company and wholly-owned subsidiary of BlueRiver (“Merger Sub”), and Spinal Stabilization Technologies, LLC, a Texas limited liability company ( “SST”) (such agreement, the “Merger Agreement”), a copy of which is attached to this proxy statement/prospectus as Annex A and incorporated herein by reference, and the transactions contemplated therein, including the business combination whereby (i) BlueRiver will de-register as an exempted company in the Cayman Islands and transfer by way of continuation as a Delaware corporation (the “Domestication”) and (ii) on the Closing Date, following the Domestication, Merger Sub will merge with and into SST (the “Merger” and together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”) with SST continuing as the surviving entity of the Merger and a subsidiary of BlueRiver (the “Surviving Company”) (the “Business Combination Proposal”);

2.      Proposal No. 2A — the Conversion Amendment Proposal — to consider and vote upon a proposal, by special resolution, to amend the Existing Organizational Documents to provide that the Class B Ordinary Shares may be converted either at the time of the consummation of the initial Business Combination or at any earlier date at the option of the holders of the Class B Ordinary Shares (the “Conversion Amendment”), as described in more detail in this proxy statement/prospectus (the “Conversion Amendment Proposal”).

3.      Proposal No. 2B — The Domestication Proposal — to consider and vote upon a proposal, by special resolution, to approve the de-registration of BlueRiver as an exempted company in the Cayman Islands and its registration by way of continuation as a corporation incorporated under the laws of the State of Delaware. The Domestication will be effected immediately prior to the consummation of the Business Combination by BlueRiver filing a Certificate of Corporate Domestication and a Certificate of Incorporation with the Delaware Secretary of State and filing an application to de-register with the Registrar of Companies of the Cayman Islands. Upon the effectiveness of the Domestication, BlueRiver will become a Delaware corporation and will change its corporate name to “Spinal Stabilization Technologies, Inc.” and all outstanding securities of BlueRiver will convert to outstanding securities of the Company, as described in more detail in this proxy statement/prospectus (the “Domestication Proposal”).

4.      Proposal No. 3 — The Organizational Documents Proposals — to consider and vote upon, on a non-binding advisory basis, certain governance provisions in the Certificate of Incorporation (collectively, the “Organizational Documents Proposals”), to approve the following material differences between the current amended and restated memorandum and articles of association of

BlueRiver (the “Existing Organizational Documents”) and the Certificate of Incorporation and the proposed new bylaws (the “Bylaws” and, together with the Certificate of Incorporation, the “Proposed Organizational Documents”) of the Company:

(A)    Organizational Documents Proposal 3A — An amendment to change the authorized capital stock of BlueRiver from 200,000,000 Class A ordinary shares, par value $0.0001 per share (the “Class A ordinary shares”), 20,000,000 Class B ordinary shares, par value $0.0001 per share (the “Class B ordinary shares” and, together with the Class A ordinary shares, the “ordinary shares”), and 1,000,000 preference shares, par value $0.0001 per share, to 250,000,000 shares of Class A common stock, par value $0.0001 per share (“Class A common stock”), 24,000,000 shares of Class V Common Stock, par value $0.0001 per share (the “Class V Common Stock”) and 10,000,000 shares of preferred stock, $0.0001 par value of the Company (this proposal is referred to herein as “Organizational Documents Proposal 3A”);

(B)    Organizational Documents Proposal 3B — An amendment to authorize the Company Board to make future issuances of any or all shares of Preferred Stock in one or more classes or series, with such terms and conditions as may be expressly determined by the Company Board and as may be permitted by the DGCL (this proposal is referred to herein as “Organizational Documents Proposal 3B”);

(C)    Organizational Documents Proposal 3C — An amendment to adopt Delaware as the exclusive forum for certain stockholder litigation (this proposal is referred to herein as “Organizational Documents Proposal 3C”); and

(D)    Organizational Documents Proposal 3D — Certain other changes in connection with the replacement of Existing Organizational Documents with the Certificate of Incorporation and Bylaws to be adopted as part of the Domestication, including (1) changing the post-Business Combination corporate name from “BlueRiver Acquisition Corp.” to “Spinal Stabilization Technologies, Inc.,” which is expected to occur after the Domestication in connection with the Business Combination, (2) making the Company’s corporate existence perpetual, (3) electing to not be governed by Section 203 of the DGCL, (4) granting an explicit waiver regarding corporate opportunities to non-officer or non-employee directors of the Company and (5) removing certain provisions related to our status as a blank check company that will no longer be applicable upon consummation of the Business Combination, all of which the board of directors of BlueRiver believes are necessary to adequately address the needs of the Company after the Business Combination (this proposal is referred to herein as “Organizational Documents Proposal 3D”).

5.      Proposal No. 4 — The Equity Incentive Plan Proposal — to consider and vote upon the approval by ordinary resolution of the Equity Incentive Plan (the “Equity Incentive Plan Proposal”).

6.      Proposal No. 5 — The Charter Proposal — to consider and vote upon a proposal, by special resolution, of the amendment and restatement of the Existing Organizational Documents (as defined herein) by the deletion in their entirety and the substitution in their place of the proposed new certificate of incorporation (the “Certificate of Incorporation”) of the Company (a corporation incorporated in the State of Delaware, assuming the Domestication Proposal is approved and adopted, and the filing with and acceptance by the Secretary of State of Delaware of the Certificate of Corporate Domestication in accordance with Section 388 of the Delaware General Corporation Law (the “DGCL”)), including authorization of the change in authorized share capital as indicated therein and the change of name of BlueRiver to “Spinal Stabilization Technologies, Inc.” in connection with the Business Combination (the “Charter Proposal”).

7.      Proposal No. 6 — The NYSE American Proposal — to consider and vote upon a proposal by ordinary resolution to approve, for the purposes of complying with the applicable provisions of NYSE American Listing Rules 712 and 713, the issuance of shares of Class A common stock and securities convertible into or exchangeable for Class A common stock in connection with the Business Combination (the “NYSE American Proposal”).

8.      Proposal No. 7 — The Adjournment Proposal — to consider and vote upon a proposal by ordinary resolution to approve the adjournment of the extraordinary general meeting to a later date or dates, if necessary, to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of one or more proposals at the extraordinary general meeting (this proposal is referred to herein as the “Adjournment Proposal”).

At the Warrant Holders Meeting, warrant holders of BlueRiver will be asked to consider and vote upon the following proposals:

1.      Proposal No. 1 — The Warrant Amendment Proposal — to approve and adopt the amendment to the Warrant Agreement (the “Warrant Amendment”), a copy of which is attached to the accompanying proxy statement/prospectus as Annex I, and the transactions contemplated thereby. In accordance with the terms and subject to the conditions of the Warrant Amendment, among other things, on the Closing Date after the Domestication and before the effective time of the Merger, each of the then outstanding BlueRiver Warrants will be cancelled and exchanged for 0.075 shares of Class A common stock, par value $0.0001 per share, of the surviving entity of the Merger and a subsidiary of BlueRiver (the “Warrant Amendment Proposal”).

2.      Proposal No. 2 — The Adjournment Proposal — to consider and vote upon a proposal by ordinary resolution to approve the adjournment of the Warrant Holders Meeting to a later date or dates,   if necessary, (a) to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of the Warrant Amendment Proposal at the Warrant Holders Meeting or (b) if the BlueRiver Board determines before the Warrant Holders Meeting that it is not necessary or no longer desirable to proceed with the proposals (this proposal is referred to herein as the “Warrant Holders Adjournment Proposal” and together with the Warrant Amendment Proposal, the “Warrant Holder Proposals”).

This proxy statement/prospectus does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, or the solicitation of a proxy, in any jurisdiction to or from any person to whom it is not lawful to make any such offer or solicitation in such jurisdiction.

This proxy statement/prospectus incorporates important business and financial information about BlueRiver that is not included in or delivered with the document.

You may request copies of this proxy statement/prospectus, without charge, by written or oral request to BlueRiver’s proxy solicitor at:

Okapi Partners LLC
Telephone: (855) 208-8903
Bank and Brokers can call at (212) 297-0720
Email: info@okapipartners.com

To obtain timely delivery of requested materials, you must request the documents no later than five business days prior to the date of the Shareholders Meeting and the Warrant Holders Meeting.

You may also obtain additional information about us from documents filed with the SEC by following the instructions in the section entitled “Where You Can Find Additional Information.”

MARKET, INDUSTRY AND OTHER DATA

This proxy statement/prospectus contains estimates, projections and other information concerning SST’s industry, including market size and growth of the markets in which it participates, that are based on industry publications and reports and forecasts prepared by its management. In some cases, SST does not expressly refer to the sources from which these estimates and information are derived. While we are not aware of any misstatements regarding the market, industry or other data presented herein, such projections, assumptions and estimates of the future performance of the industry in which SST operates and SST’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors.” These and other factors could cause results to differ materially from those expressed in these publications and reports.

Certain estimates of market opportunity, including internal estimates of the addressable market for SST and forecasts of market growth, included in this proxy statement/prospectus may prove inaccurate. Market opportunity estimates and growth forecasts, whether obtained from third-party sources or developed internally, are subject to significant uncertainty and are based on assumptions and estimates that may prove to be inaccurate. The estimates and forecasts in this proxy statement/prospectus relating to the size of SST’s target market, market demand and adoption, capacity to address this demand, and pricing may prove to be inaccurate. The addressable market SST estimates may not materialize for many years, if ever, and even if the markets in which it competes meet the size estimates in this proxy statement/prospectus, SST’s business could fail to successfully address or compete in such markets, if at all.

Certain monetary amounts, percentages and other figures included in this proxy statement/prospectus have been subject to rounding adjustments. Certain other amounts that appear in this proxy statement/prospectus may not sum due to rounding.

SELECTED DEFINITIONS

QUESTIONS AND ANSWERS ABOUT THE BUSINESS COMBINATION AND
THE EXTRAORDINARY GENERAL MEETING

Q.     Why am I receiving this proxy statement/prospectus?

A.     You are receiving this proxy statement/prospectus in connection with the Shareholders Meeting of BlueRiver’s shareholders and the Warrant Holders Meeting of BlueRiver’s warrant holders. BlueRiver is holding the Shareholders Meeting and the Warrant Holders Meeting to consider and vote upon the Proposals described below. Your vote is important. You are encouraged to vote as soon as possible after carefully reviewing this proxy statement/prospectus.

Q.     What is being voted on at the Shareholders Meeting?

A.     BlueRiver’s shareholders are being asked to consider and vote upon the Business Combination Proposal to approve the Merger Agreement and the Business Combination contemplated thereby. The Merger Agreement provides that, among other things, BlueRiver will acquire certain Surviving Company Class A Membership Units, with BlueRiver continuing to operate as the Company and SST becoming a direct subsidiary of the Company. Shareholder approval of the Merger Agreement and the transactions contemplated thereby is required by the Merger Agreement and the Amended and Restated Memorandum and Articles of Association. A copy of the Merger Agreement is attached to this proxy statement/ prospectus as Annex A and BlueRiver encourages its shareholders to read it in its entirety. See the section entitled “Proposal 1: The Business Combination Proposal.”

BlueRiver’s shareholders are also being asked to consider and vote upon the Conversion Amendment Proposal to amend the Existing Organizational Documents to provide that the Class B Ordinary Shares may be converted either at the time of the consummation of the initial Business Combination or at any earlier date at the option of the holders of the Class B Ordinary Shares, as described in more detail in this proxy statement/prospectus (the “Conversion Amendment Proposal”). See the section entitled “Proposal 2A: The Conversion Amendment Proposal.” BlueRiver’s shareholders are also being asked to consider and vote upon the Domestication Proposal to change the corporate structure and domicile of BlueRiver by way of continuation from an exempted company incorporated under the laws of the Cayman Islands to a corporation incorporated under the laws of the State of Delaware. The Domestication will be effected by BlueRiver filing a Certificate of Corporate Domestication and a Certificate of Incorporation with the Delaware Secretary of State and filing an application to de-register with the Registrar of Companies of the Cayman Islands and all outstanding securities of BlueRiver will convert to outstanding securities of the Company, as described in more detail in this proxy statement/prospectus. In connection with the Domestication, and simultaneously with the Business Combination, BlueRiver will change its corporate name to “Spinal Stabilization Technologies, Inc.” The Domestication will become effective immediately prior to the completion of the Business Combination. The form of the proposed Delaware Certificate of Incorporation of the Company is attached to this proxy statement/prospectus as Annex B. See the section entitled “Proposal 2B: The Domestication Proposal.”

BlueRiver’s shareholders are also being asked to consider and vote upon a non-binding advisory basis the Organizational Documents Proposals to approve certain material differences between the Existing Organizational Documents and the Proposed Organizational Documents of the Company (a corporation incorporated in the State of Delaware), assuming the Charter Proposal is approved and adopted. See the section entitled “Proposal 3: The Organizational Documents Proposals.”

BlueRiver’s shareholders are also being asked to consider and vote upon the Equity Incentive Plan Proposal to adopt the Equity Incentive Plan. Among other things, the Equity Incentive Plan, which would become effective upon the completion of the Business Combination, is intended to maintain and strengthen the Company’s ability to attract and retain key employees, directors, consultants and certain other individuals providing services to the Company and to motivate them to remain focused on long-term shareholder value. See the section entitled “Proposal 4: The Equity Incentive Plan Proposal.” A copy of the Equity Incentive Plan is attached to this proxy statement/prospectus as Annex C, and BlueRiver encourages its shareholders to read the plan in its entirety.

BlueRiver’s shareholders are also being asked to consider and vote upon the amendment and restatement of the Existing Organizational Documents in their entirety by the new Certificate of Incorporation, assuming the Domestication Proposal is approved and adopted, and the filing with and acceptance by the Secretary of

State of Delaware of the certificate of domestication in accordance with Section 388 of the DGCL, including the authorization of the change in authorized share capital as indicated therein and the change of name of BlueRiver to “Spinal Stabilization Technologies, Inc.” in connection with the Business Combination. The new Certificate of Incorporation of the Company is attached hereto as Annex B and BlueRiver encourages its shareholders to read it in its entirety. See the section entitled “Proposal 5: The Charter Proposal.”

BlueRiver’s shareholders are also being asked to consider and vote upon the NYSE American Proposal. Our units, ordinary shares, and public warrants are listed on NYSE American and, as such, we are seeking shareholder approval for the purposes of complying with the applicable provisions of the NYSE American Listing Rules 712 and 713 of the issuance of shares of Class A common stock and securities convertible into or exchangeable for Class A common stock in connection with the Business Combination. See the section entitled “Proposal 6: The NYSE American Proposal.”

BlueRiver’s shareholders are also being asked to consider and vote upon the Adjournment Proposal to adjourn the Shareholders Meeting to a later date or dates, including, if necessary, to permit further solicitation and vote of proxies if it is determined by BlueRiver that more time is necessary or appropriate to approve one or more Shareholder Proposals at the Shareholders Meeting. See the section entitled “Proposal 7: The Adjournment Proposal.”

The presence, in person or by proxy, of BlueRiver shareholders representing one-third of the issued and outstanding BlueRiver Ordinary Shares on the Record Date and entitled to vote on the Shareholder Proposals to be considered at the Shareholders Meeting will constitute a quorum for the Shareholders Meeting.

Q.     What is being voted on at the Warrant Holders Meeting?

A.     BlueRiver’s warrant holders are being asked to consider and vote upon the Warrant Amendment Proposal to approve the amendment of the Warrant Agreement to provide that, on the Closing Date after the Domestication and before the effective time of the Merger, each of the then outstanding BlueRiver Warrants will be cancelled and exchanged for 0.075 shares of shares of Surviving Pubco Class A Common Stock. See the section entitled “Warrant Holder Proposal No. 1—The Warrant Amendment Proposal.”

BlueRiver’s warrant holders are also being asked to consider and vote upon the Warrant Holders Adjournment Proposal to adjourn the Warrant Holders Meeting to a later date or dates, including, if necessary, to permit further solicitation and vote of proxies if it is determined by BlueRiver that more time is necessary or appropriate to approve one or more Warrant Holder Proposals at the Warrant Holders Meeting. See the section entitled “Warrant Holder No. 2: The Warrant Holders Adjournment Proposal.”

The presence, in person or by proxy, of BlueRiver warrant holders representing 50% of the outstanding BlueRiver Warrants on the Record Date and entitled to vote on the Warrant Holder Proposals to be considered at the Warrant Holders Meeting will constitute a quorum for the Warrant Holders Meeting.

YOUR VOTE IS IMPORTANT. YOU ARE ENCOURAGED TO VOTE AS SOON AS POSSIBLE AFTER CAREFULLY REVIEWING THIS PROXY STATEMENT/PROSPECTUS.

Q.     Are the Shareholder Proposals conditioned on one another?

A.     Each of the Business Combination Proposal, the Conversion Amendment Proposal, the Domestication Proposal, the Charter Proposal and the NYSE American Proposal is interdependent upon the others and each must be approved in order for BlueRiver to complete the Business Combination contemplated by the Merger Agreement. None of the Organizational Documents Proposals, which will be voted upon a non-binding advisory basis only, the Equity Incentive Plan Proposal or the Adjournment Proposal is conditioned upon the approval of any other proposal. The Business Combination Proposal, the Equity Incentive Plan Proposal, the Organization Documents Proposal, the NYSE American Proposal and the Adjournment Proposal will require an ordinary resolution as matter of Cayman Islands law, being the affirmative vote of the holders of a majority, as of the Record Date, of the BlueRiver Ordinary Shares that are present and vote at the Shareholders Meeting. The Charter Proposal, the Conversion Amendment Proposal and the Domestication Proposal will require a special resolution as a matter of Cayman Islands law, being the affirmative vote of the holders of a majority of at least two-thirds, as of the Record Date, of the BlueRiver Ordinary Shares that are present and vote at the Shareholders Meeting.

Q.     Why is BlueRiver proposing the Conversion Amendment?

A.     The BlueRiver Board is proposing to amend the Existing Organizational Documents to provide that the Class B Ordinary Shares may be converted either at the time of the consummation of the initial Business Combination or at any earlier date at the option of the holders of the Class B Ordinary Shares (the “Conversion Amendment”), such that the holders of the Class B Ordinary Shares can convert their shares at the effective time of the Domestication and prior to the consummation of the Business Combination.

Q.     Why is BlueRiver proposing the Warrant Amendment?

A.     The BlueRiver Board is proposing to amend the Warrant Agreement to provide that, on the Closing Date after the Domestication and before the effective time of the Merger, each of the then outstanding BlueRiver Warrants will be cancelled and exchanged for 0.075 shares of shares of Surviving Pubco Class A Common Stock.

Q.     Why is BlueRiver proposing the Domestication?

A.     The BlueRiver Board believes that it would be in the best interests of BlueRiver to effect the Domestication to enable the Company to avoid certain taxes that would be imposed on the Company if the Company were to conduct an operating business in the United States as a foreign corporation following the Business Combination. In addition, the BlueRiver Board believes Delaware provides a recognized body of corporate law that will facilitate corporate governance by the Company’s officers and directors. Delaware maintains a favorable legal and regulatory environment in which to operate. For many years, Delaware has followed a policy of encouraging companies to incorporate there and, in furtherance of that policy, has adopted comprehensive, modern and flexible corporate laws that are regularly updated and revised to meet changing business needs. As a result, many major corporations have initially chosen Delaware as their domicile or have subsequently reincorporated in Delaware in a manner similar to the procedures BlueRiver is proposing. Due to Delaware’s longstanding policy of encouraging incorporation in that state and consequently its prevalence as the state of incorporation, the Delaware courts have developed a considerable expertise in dealing with corporate issues and a substantial body of case law has developed construing the DGCL and establishing public policies with respect to Delaware corporations. It is anticipated that the DGCL will continue to be interpreted and explained in a number of significant court decisions that may provide greater predictability with respect to the Company’s corporate legal affairs.

The Domestication will not occur unless the BlueRiver shareholders have approved the Domestication Proposal, the Business Combination Proposal, the Charter Proposal and the NYSE American Proposal and upon the Merger Agreement being in full force and effect prior to the Domestication. The Domestication will only occur upon the simultaneous completion of the Business Combination.

Q.     What is involved with the Domestication?

A.     The Domestication will require BlueRiver to file certain documents in both the Cayman Islands and the State of Delaware. At the effective time of the Domestication, which will be the Closing Date, BlueRiver will cease to be an exempted company incorporated under the laws of the Cayman Islands and in connection with the Business Combination, BlueRiver will continue as a Delaware corporation and, simultaneously with the Business Combination, will change its corporate name to “Spinal Stabilization Technologies, Inc.”. The Amended and Restated Memorandum and Articles of Association will be replaced by the Delaware Certificate of Incorporation and Bylaws and your rights as a shareholder will cease to be governed by the laws of the Cayman Islands and will be governed by Delaware law.

Q.     When do you expect that the Domestication will be effective?

A.     The Domestication is expected to become effective immediately prior to the completion of the Business Combination.

Q.     How will the Domestication affect my securities of BlueRiver?

A.     Pursuant to the Domestication and the Business Combination and without further action on the part of BlueRiver’s shareholders, each outstanding Class A ordinary share and Class B ordinary share of BlueRiver will convert to one outstanding share of the Company’s Class A common stock. Although it will not be necessary for you to exchange your certificates representing ordinary shares after the Domestication, the

Company will, upon request, exchange your BlueRiver share certificates for the applicable number of shares of Company’s Class A common stock, and all certificates for securities issued after the Domestication will be certificates representing securities of the Company.

Q.     What are the material U.S. federal income tax consequences of the Domestication to Holders of BlueRiver Shares and Warrants?

A.     As discussed more fully under the section entitled “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences” below, the Domestication should constitute a reorganization within the meaning of Section 368(a)(l)(F) of the Code. However, due to the absence of direct guidance on the application of Section 368(a)(1)(F) of the Code to a statutory conversion of a corporation holding only investment-type assets such as BlueRiver, this result is not entirely clear. In the case of a transaction, such as the Domestication, that should qualify as a reorganization within the meaning of Section 368(a)(1)(F) of the Code, U.S. Holders (as defined in such section) of BlueRiver Shares will be subject to Section 367(b) of the Code and, as a result:

•        a U.S. Holder of BlueRiver Shares whose BlueRiver Shares have a fair market value of less than $50,000 on the date of the Domestication, and who on the date of the Domestication owns (actually and constructively) less than 10% of the total combined voting power of all classes of BlueRiver Shares entitled to vote and less than 10% of the total value of all classes of BlueRiver Shares, will generally not recognize any gain or loss and will generally not be required to include any part of BlueRiver’s earnings in income pursuant to the Domestication;

•        a U.S. Holder of BlueRiver Shares whose BlueRiver Shares have a fair market value of $50,000 or more on the date of the Domestication, and who on the date of the Domestication owns (actually and constructively) less than 10% of the total combined voting power of all classes of BlueRiver Shares entitled to vote and less than 10% of the total value of all classes of BlueRiver Shares will generally recognize gain (but not loss) on the exchange of BlueRiver Shares for shares in the Company (a Delaware corporation) pursuant to the Domestication. As an alternative to recognizing gain, such U.S. Holders may file an election to include in income as a dividend the “all earnings and profits amounts” (as defined in Treasury Regulation Section 1.367(b)-2(d)) attributable to their BlueRiver Shares, provided certain other requirements are satisfied. BlueRiver does not expect to have significant cumulative earnings and profits on the date of the Domestication; and

•        a U.S. Holder of BlueRiver Shares who on the date of the Domestication owns (actually and constructively) 10% or more of the total combined voting power of all classes of BlueRiver Shares entitled to vote or 10% or more of the total value of all classes of BlueRiver Shares will generally be required to include in income as a dividend the “all earnings and profits amount” (as defined in Treasury Regulation Section 1.367(b)-2(d)) attributable to its BlueRiver Shares, provided certain other requirements are satisfied. Any such U.S. Holder that is a corporation may, under certain circumstances, effectively be exempt from taxation on a portion or all of the deemed dividend pursuant to Section 245A of the Code. BlueRiver does not expect to have significant cumulative earnings and profits on the date of the Domestication.

In the case of a transaction, such as the Domestication, that should qualify as a reorganization within the meaning of Section 368(a)(1)(F) of the Code, a U.S. Holder of BlueRiver Shares or Public Warrants may, in certain circumstances, still recognize gain (but not loss) upon the exchange of its BlueRiver Shares or Public Warrants for the common stock of the Delaware corporation pursuant to the Domestication under the “passive foreign investment company,” or PFIC, rules of the Code. Proposed Treasury Regulations with a retroactive effective date have been promulgated under Section 1291(f) of the Code which generally require that a U.S. person who disposes of stock of a PFIC (including for this purpose exchanging Public Warrants for newly issued warrants in the Domestication) must recognize gain equal to the excess, if any, of the fair market value of the common stock or warrants of the Delaware corporation received in the Domestication and the U.S. Holder’s adjusted tax basis in the corresponding BlueRiver Shares or Public Warrants surrendered in exchange therefor, notwithstanding any other provision of the Code. Because BlueRiver is a blank check company with no current active business, we believe that BlueRiver likely is classified as a PFIC for U.S. federal income tax purposes. As a result, these proposed Treasury Regulations, if finalized in their current form, would generally require a U.S. Holder of BlueRiver Shares or Public Warrants to recognize gain on the exchange of such shares or warrants for common stock or warrants of the Delaware corporation pursuant to the Domestication, unless, in the case of only common

stock, such U.S. Holder has made certain tax elections with respect to such U.S. Holder’s BlueRiver Shares. A U.S. Holder cannot currently make the aforementioned elections with respect to such U.S. Holder’s Public Warrants. The tax on any such gain so recognized would be imposed at the rate applicable to ordinary income and an interest charge would apply based on complex rules designed to offset the tax deferral to such U.S. Holder on the undistributed earnings, if any, of BlueRiver. It is not possible to determine at this time whether, in what form, and with what effective date, final Treasury Regulations under Section 1291(f) of the Code will be adopted. For a more complete discussion of the potential application of the PFIC rules to U.S. Holders as a result of the Domestication, see the discussion in the section entitled “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences — PFIC Considerations.”

Additionally, the Domestication may cause Non-U.S. Holders (as defined in “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences”) to become subject to U.S. federal withholding taxes on any dividends paid in respect of such Non-U.S. Holder’s Company shares after the Domestication.

The tax consequences of the Domestication are complex and will depend on a holder’s particular circumstances. All holders are urged to consult their tax advisors on the tax consequences to them of the Domestication, including the applicability and effect of U.S. federal, state and local non-U.S. income and other tax laws. For a more complete discussion of the U.S. federal income tax considerations of the Domestication, including with respect to Public Warrants, see “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences.”

Q.     What are the material U.S. federal income tax consequences to Holders of BlueRiver Shares that exercise their Redemption Rights?

A.     As discussed more fully under the section entitled “Proposal 1: The Business Combination Proposal — Material U.S. Federal Income Tax Consequences” below, it is expected that a U.S. Holder (as defined in such section) that exercises its Redemption Rights to receive cash in exchange for its Company shares will generally be treated as selling such Company shares resulting in the recognition of capital gain or capital loss. There may be certain circumstances in which the redemption may be treated as a distribution for U.S. federal income tax purposes depending on the amount of Company shares that such U.S. Holder owns or is deemed to own (including through the ownership of warrants).

Additionally, because the Domestication will occur immediately prior to the redemption by any public shareholders, it is expected that U.S. Holders exercising Redemption Rights will be subject to the potential tax consequences of Section 367(b) of the Code and the potential tax consequences of the PFIC rules as a result of the Domestication.

For a description of the tax consequences for Holders of BlueRiver Shares exercising Redemption Rights in connection with the Business Combination, see the sections entitled “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences — U.S. Holders — Tax Consequences to U.S. Holders That Elect to Exercise Redemption Rights” and “Proposal 2B: The Domestication Proposal — Material U.S. Federal Income Tax Consequences — Non-U.S. Holders — Tax Consequences to Non-U.S. Holders That Elect to Exercise Redemption Rights.”

All holders of BlueRiver Shares considering exercising their Redemption Rights are urged to consult their tax advisors on the tax consequences to them of an exercise of Redemption Rights, including the applicability and effect of U.S. federal, state and local non-U.S. income and other tax laws.

Q.     What are the material U.S. federal income tax consequences of the Warrant Amendment?

A.     As discussed more fully under “Material U.S. Federal Income Tax Consequences,” it is expected that, for U.S. federal income tax purposes, the Warrant Amendment should be treated as a tax-free “recapitalization” within the meaning of Section 368(a)(1)(E). As a result of such treatment, U.S. holders and non-U.S. holders of BlueRiver Warrants should generally not recognize gain or loss for U.S. federal income tax purposes on the Warrant Amendment.

All holders of BlueRiver Warrants are urged to consult their tax advisors on the tax consequences to the Warrant Amendment, including the applicability and effect of U.S. federal, state and local non-U.S. income and other tax laws.

Q.     Why is BlueRiver proposing the Business Combination?

A.     BlueRiver was organized for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or other similar business combination with one or more businesses or entities. Since BlueRiver’s incorporation, the BlueRiver Board has sought to identify suitable candidates in order to effect such a transaction. In its review of SST, the BlueRiver Board considered a variety of factors weighing positively and negatively in connection with the Business Combination. After careful consideration, the BlueRiver Board has determined that the Business Combination presents a highly-attractive business combination opportunity and is in the best interests of BlueRiver shareholders. The BlueRiver Board believes that, based on its review and consideration, the Business Combination with SST presents an opportunity to increase shareholder value. However, there can be no assurance that the anticipated benefits of the Business Combination will be achieved. Shareholder approval of the Business Combination is required by the Merger Agreement and the Amended and Restated Memorandum and Articles of Association, as well as to comply with NYSE American Listing Rules 712 and 713.

Q.     What will happen in the Business Combination?

A.     The Business Combination consists of a series of transactions pursuant to which (i) BlueRiver will complete the Domestication and (ii) BlueRiver will acquire certain Surviving Company Class A Membership Units in the amounts set forth herein, with BlueRiver continuing to operate as the Company and SST becoming a direct subsidiary of the Company. Upon the completion of the Domestication and the Business Combination, each issued and outstanding Class A ordinary share and Class B ordinary share of BlueRiver will become a share of Class A common stock, and each issued and outstanding warrant to purchase Class A ordinary shares of BlueRiver will become a warrant to purchase an equal number of shares of Class A common stock of the Company.

Q.     What consideration will SST receive in connection with the Business Combination?

A.     In accordance with the terms and subject to the conditions of the Merger Agreement, BlueRiver will effect the Business Combination with SST in exchange for a combination of certain newly-issued equity interests of SST and newly-issued shares of Class V Common Stock of BlueRiver, which will have no economic value, but will entitle each SST Holder to one vote per issued share and will be issued on a one-for-one basis for each membership unit in SST retained by SST Holders following the Business Combination. For further details, see “Proposal 1: The Business Combination Proposal — The Merger Agreement — Consideration to be Received in the Business Combination.”

Following the completion of the Business Combination, as described above, our organizational structure will be what is commonly referred to as an umbrella partnership corporation (or Up-C) structure. This organizational structure will allow the SST Holders to retain their equity ownership in SST, an entity that is classified as a partnership for U.S. federal income tax purposes, in the form of Surviving Company Class A Membership Units. The SST Holders will also hold a number of shares of Class V Common Stock equal to the number of Surviving Company Class A Membership Units held by the SST Holders. The shares of Class V Common Stock will have no economic value, but which will entitle the holder thereof to one vote per share at any meeting of the shareholders of the Company. Those investors who, prior to the Business Combination, held Class A ordinary shares or Class B ordinary shares of BlueRiver will, by contrast, hold their equity ownership in the Company, a Delaware corporation that is a domestic corporation for U.S. federal income tax purposes. The parties agreed to structure the Business Combination in this manner for tax and other business purposes, and although we believe there will be a tax benefit to the current SST Holders, we do not believe that our Up-C organizational structure will give rise to any significant benefit or detriment to the business or financial performance of the Company. See the section entitled “Risk Factors — Risks Related to the Business Combination and BlueRiver” for additional information on our organizational structure.

Upon the completion of the Business Combination, based on an assumed liquidation on December 26, 2023 pursuant to Section 5.4 of SST’s operating agreement, each Class A1, A2, B1 and B2 Membership Interest unit of SST would be entitled to receive approximately 3.308 Surviving Company Class A Membership Units and a corresponding number of shares of Surviving Pubco Class V Common Stock, which would be exchangeable into approximately 3.308 shares of Class A Common Stock of the Company. Each Class RB2 Membership Interest unit of SST will vest in full and convert into approximately 2.437 Surviving Company

Class A Membership Units and a corresponding number of shares of Surviving Pubco Class V Common Stock upon consummation of the Business Combination, which would be exchangeable into approximately 2.437 shares of Class A Common Stock of the Company. Based on the assumed value of $10.00 per share of Class A Common Stock of the Company used in the Merger Agreement to determine the aggregate number of Surviving Company Class A Membership Units and corresponding shares of Surviving Pubco Class V Common Stock issuable to all SST Membership Interest unit holders, the per unit value of each Class A1, A2, B1 and B2 Membership Interest unit of SST and each Class RB2 Membership Interest unit of SST would be approximately $33.08 and $24.37, respectively.

The actual numbers of Surviving Company Class A Membership Units and shares of Surviving Pubco Class V Common Stock to be issued to the SST Holders is subject to change prior to Closing based on SST’s operating agreement and the Merger Agreement and will set forth on an allocation statement to be delivered by the Company to BlueRiver in connection with the consummation of the transactions contemplated by the Merger Agreement, and the actual value of any Class A Common Stock into which such Surviving Company Class A Membership Units and corresponding shares of Surviving Pubco Class V Common Stock will depend on the trading prices of the Class A Common Stock of the Company at the time of any such exchange, which could vary significantly from the assumptions used above. See the section entitled “Proposal 1 — The Business Combination Proposal — Business Combination Consideration” and “Risk Factors — Risks Related to Our Common Stock and Being a Public Company” for additional information on the Business Combination consideration.

Q.     What equity stake will current BlueRiver shareholders and SST hold in the Company immediately after the completion of the Business Combination?

A.      Upon the completion of the Business Combination (assuming, among other things, that no BlueRiver shareholders exercise Redemption Rights with respect to their ordinary shares upon completion of the Business Combination and the other assumptions described under the section entitled “Frequently Used Terms — Share Calculations and Ownership Percentages”), the current holders of BlueRiver Ordinary Shares are expected to own shares of the Company’s outstanding Class A common stock representing approximately [•]% of the voting power of the Company and the current holders of SST membership units are expected to own shares of the Company’s outstanding Class A common stock representing approximately [•]% of the voting power of the Company.

If any of BlueRiver’s shareholders exercise their Redemption Rights, the percentage of the Company’s outstanding voting stock held by the current holders of BlueRiver Ordinary Shares will decrease and the percentage of the Company’s outstanding voting stock held by the SST Holders will increase, in each case relative to the percentage held if none of the BlueRiver Ordinary Shares are redeemed.

The relative percentage above is for illustrative purposes only and is based upon certain assumptions as described in the section entitled “Frequently Used Terms — Share Calculations and Ownership Percentages.”

Should one or more of the assumptions prove incorrect, actual beneficial ownership percentages may vary materially from those described in this proxy statement/prospectus as anticipated, believed, estimated, expected or intended.

Q.     What is the expected per share value of the cash consideration to be received by BlueRiver in the Business Combination?

A.      As described in “— What happens if a substantial number of Public Shareholders vote in favor of the Business Combination and exercise their redemption rights?” the net cash to the balance sheet of BlueRiver and the total number of Common Stock shares outstanding immediately following the consummation of the Business Combination will depend upon the extent to which Public Shareholders exercise their redemption rights. The Existing Organizational Documents do not provide a specified maximum redemption threshold, except that in no event will BlueRiver redeem Public Shares in an amount that would cause its net tangible assets to be less than $5,000,001 after giving effect to the transactions contemplated by the Merger Agreement, if consummated (such that BlueRiver is not subject to the SEC’s “penny stock” rules). Although the parties to the Business Combination have deemed the value of Class A ordinary shares to be equal to $10.00 per share for purposes of determining the number of Surviving Company Class A Common Units and corresponding non-economic voting shares of Surviving Pubco Class V Common Stock issuable to SST Holders in the Merger, the net cash per Public Share resulting from the proceeds of the Trust Account is expected to be less than $10.00 per share following the Business Combination. Set forth below is a calculation of the net cash per Class A ordinary share resulting from

the proceeds of the Trust Account in a no redemption scenario, 50% redemption scenario, and the maximum redemption scenario. Such calculations are based upon (1) the aggregate cash held in the Trust Account as of August 28, 2023 of approximately $19,849,720 and (2) estimated transaction expenses of $7,000,000, excluding the amount expected to be outstanding under the Promissory Note issued by BlueRiver to the Sponsor that will be repaid at the closing of the Business Combination. The table below assumes no debt or equity financing is consummated prior to, or in connection with, the closing of the Business Combination, and that the warrant exchange is not consummated.

____________

*        Amount is less than zero.

(1)      This scenario assumes that 1,872,928 Public Shares are not redeemed by BlueRiver shareholders.

(2)      This scenario assumes that 936,464 Public Shares are not redeemed by BlueRiver shareholders.

(3)      This scenario assumes that all Public Shares are redeemed by BlueRiver shareholders.

(4)      Excludes 1,774,375 of restricted Founder Shares that are prevented from trading directly following the Business Combination and are also forfeitable. Includes 5,413,125 Founders Shares vested at the Closing. Includes 800,000 Sponsor Private Placement Shares.

The following table shows the potential impact of redemptions on the per share equity value of the outstanding Class A ordinary shares on a pro forma basis as of September 30, 2023 taking into account the per share book equity value of the Company after giving effect to the Business Combination, including the impact of the Class A Common Stock issuable upon exchange of Surviving Company Class A Common Units and corresponding Surviving Pubco Class V Common Stock issued to equity holders of SST in the Merger and assumes that the warrant exchange is not consummated:

____________

(1)      Includes 24,000,000 shares of Company Class A Common Stock issuable upon exchange of Surviving Company Class A Common Units and corresponding Surviving Pubco Class V Common Stock issuable in the Merger.

(2)      As of September 30, 2023.

(3)      Excludes 9,583,270 and 266,667 shares of Class A Common Stock issuable upon exercise of Public Warrants and Private Placement Warrants, respectively, each with an exercise price of $11.50 per share (assuming the warrant exchange is not consummated). Such shares are not included as the effect would be anti-dilutive.

Q:     What are the possible sources and the extent of dilution that the Public Shareholders that elect not to redeem their shares will experience in connection with the Business Combination?

A:     After the completion of the Business Combination, Public Shareholders will own a significantly smaller percentage of the Surviving Pubco than they currently own of BlueRiver. Consequently, the Public Shareholders, as a group, will have reduced ownership and voting power in the Surviving Pubco compared to their ownership and voting power in BlueRiver. The table below assumes (1) full exercise of Public Warrants and Private Placement Warrants, and (2) no debt or equity financing is consummated prior to, or in connection with, the closing of the Business Combination. As of the date of this proxy statement/prospectus, the parties have not obtained any binding commitments for a PIPE transaction. If we enter into a PIPE transaction

after the date of this proxy statement/prospectus or if a PIPE transaction becomes probable, we will present a scenario that incorporates the additional investment. See “Unaudited Pro Forma Condensed Combined Financial Information.” The following table illustrates the potential impact of redemptions on the ownership percentage of Public Shareholders in a range of redemption scenarios, with the maximum redemption scenario representing the redemption of all Public Shares and assumes that the Warrant Amendment is not adopted.

____________

(1)      Reflects the warrants contained in the 800,000 private placement units held by the Sponsor, but excludes 1,774,375 shares held by the Sponsor that are prevented from trading directly following the Business Combination and are also forfeitable, but which retain full voting rights.

Q.     Did the BlueRiver Board obtain a third-party valuation or fairness opinion in determining whether or not to proceed with the Business Combination?

A.     BlueRiver obtained a fairness opinion from its independent financial advisor, Houlihan Capital, LLC (“Houlihan Capital”), with respect to whether the consideration to be issued or paid in the Business Combination is fair from a financial point of view to the stockholders of the Company. Additionally, BlueRiver’s officers and directors have substantial experience in evaluating the operating and financial merits of companies from a wide range of industries and concluded that their experience and backgrounds, together with the experience and sector expertise of BlueRiver’s advisors and consultants, enabled them to make the necessary analyses and determinations regarding the Business Combination. In addition, BlueRiver’s officers, directors, and advisors have substantial experience with mergers and acquisitions.

Q.     What will SST and BlueRiver receive in connection with the Business Combination?

A.     In accordance with the terms and subject to the conditions of the Merger Agreement, (i) SST will (a) retain [•] Surviving Company Class A Membership Units and (b) receive [•] shares of Class V Common Stock, which will be non-economic voting stock of the Company, and (ii) BlueRiver will acquire [•] Common Units. For further details, see “Proposal 1: The Business Combination Proposal — The Merger Agreement — Business Combination Consideration.”

Q.     What happens to the funds deposited in the Trust Account after consummation of the Business Combination?

A.     Following the closing of our IPO, an amount equal to $287.5 million ($10.00 per unit) of the net proceeds from our IPO and the sale of the Private Placement Units was placed in the Trust Account. At September 30, 2023, $19.9 million remained and was held in the Trust Account for the purposes of consummating an initial business combination (which will be the Business Combination should it occur). These funds will remain in the Trust Account, except for the withdrawal of interest to pay taxes, if any, until the earliest of (1) the completion of a business combination (including the closing of the Business Combination) or (2) the redemption of all of the public shares if we are unable to complete a business combination by February 2, 2024, subject to applicable law.

If our initial business combination (which will be the Business Combination should it occur) is paid for using equity or debt securities or not all of the funds released from the Trust Account are used for payment of the consideration in connection with our initial business combination (which will be the Business Combination should it occur) or used for redemptions or purchases of the public shares, we may apply the balance of the cash released to us from the Trust Account for general corporate purposes, including for maintenance or

expansion of operations of the Company, the payment of principal or interest due on indebtedness incurred in completing our Business Combination, to fund the purchase of other companies or for working capital. See “Summary of the Proxy Statement/Prospectus — Sources and Uses of Funds for the Business Combination.”

Q.     What happens if a substantial number of the public shareholders vote in favor of the Business Combination Proposal and exercise their Redemption Rights?

A.     Our Public Shareholders are not required to vote “AGAINST” the Business Combination in order to exercise their Redemption Rights, although redemption is only available if the Business Combination is consummated. Accordingly, the Business Combination may be consummated even though the funds available from the Trust Account and the number of Public Shareholders are reduced as a result of redemptions by Public Shareholders.

The Merger Agreement provides that the obligations of the parties to consummate the Business Combination are conditioned on, among other things, that (x) the aggregate amount of cash proceeds available for release to BlueRiver from the Trust Account and (y) the net amount of proceeds actually received by BlueRiver pursuant to any equity financing consummated prior to, or in connection with, the Closing, less the aggregate amount of fees and expenses payable by BlueRiver in connection with the Business Combination and the transactions contemplated thereby that remain unpaid immediately prior to the Closing, shall be at least $10,000,000 (the “Minimum Cash Condition”). If this Minimum Cash Condition is not met, and such condition is not duly waived by SST, then the Merger Agreement could be terminated and the proposed Business Combination may not be consummated. The Merger Agreement is also subject to the satisfaction or waiver of certain other closing conditions as described in the accompanying proxy statement/prospectus. There can be no assurance that the parties to the Merger Agreement would waive any such provision of the Merger Agreement. In addition, the Merger Agreement provides that the obligations of SST and BlueRiver to consummate the Business Combination are conditioned on, among other things, BlueRiver having, after giving effect to the Business Combination and the transactions contemplated thereby, net tangible assets (as determined in accordance with Rule 3a51-1(g)(1) of the Exchange Act) of at least $5,000,001. As of the date of this proxy statement/prospectus, BlueRiver and SST have not obtained any subscriptions for a PIPE Financing. In the event that such subscriptions are obtained prior to the Closing, BlueRiver will disclose such subscriptions in a supplement to this proxy statement/prospectus.

Additionally, as a result of redemptions, the trading market for the Class A common stock of the Company may be less liquid than the market for the Public Shares was prior to consummation of the Business Combination and we may not be able to meet the listing standards for NYSE American or another national securities exchange.

Q.     What conditions must be satisfied to complete the Business Combination?

A.     The consummation of the Business Combination is subject to the satisfaction or waiver of certain customary closing conditions of the respective parties, including, among others: (a) the approval of each of the Business Combination Proposal, the Domestication Proposal, the Charter Proposal, and the NYSE American Proposal by BlueRiver shareholders; (b) the Merger Agreement and applicable ancillary documents have been approved by the Company members; (c) the Merger Agreement and other applicable ancillary documents have been approved by the requisite BlueRiver shareholders; (d) the waiting period under the HSR Act (or any extension thereof) applicable to the consummation of the transactions contemplated by the Merger Agreement, if any, shall have expired or been terminated; (e) there shall not be any applicable law in effect that makes the consummation of the transactions contemplated by the Merger Agreement illegal or any order in effect preventing the consummation of the transactions contemplated thereby; (f) the Minimum Cash Condition shall be satisfied; (g) this Form S-4 shall have become effective in accordance with the provisions of the Securities Act, no stop order shall have been issued by the SEC and no proceeding seeking such stop order has been threatened or initiated by the SEC that remains pending; (h) after giving effect to the transactions contemplated by the Merger Agreement, the Company has at least $5,000,001 of net tangible assets immediately after the Effective Time; (i) no Company Material Adverse Effect (as defined in the Merger Agreement) has occurred that is continuing; (j) receipt of approval for listing on the NYSE American, or any other national securities exchange that may be agreed upon by BlueRiver and SST, the shares of Class A Common Stock to be issued in connection with the Business Combination; and (k) consummation of the Domestication.

For a summary of the conditions that must be satisfied or waived prior to completion of the Business Combination, see the section entitled, “Proposal 1: The Business Combination Proposal — The Merger Agreement — Closing Conditions.”

Q.     When do you expect the Business Combination to be completed?

A.     It is currently expected that the Business Combination will be completed in the [•]. This timing depends, among other things, on the approval of the Shareholder Proposals to be presented at the Shareholders Meeting and the Warrant Holders Proposals to be presented at the Warrant Holders Meeting. However, the Shareholders Meeting and/or the Warrant Holders Meeting could be adjourned if the Adjournment Proposal and/or the Warrant Holders Adjournment Proposal, as applicable, is adopted at the Shareholders Meeting and/or the Warrant Holders Meeting and BlueRiver elects to adjourn the Shareholders Meeting and/or the Warrant Holders Meeting to a later date or dates to permit further solicitation and vote of proxies if reasonably determined to be necessary or desirable by BlueRiver.

Q.     What happens if the Business Combination is not completed?

A.     If a Public Shareholder has tendered shares to be redeemed but the Business Combination is not completed, the Redemptions will be canceled and the tendered shares will be returned to the relevant Public Shareholders as appropriate. The current deadline set forth in the Amended and Restated Memorandum and Articles of Association for BlueRiver to complete its initial business combination (which will be the Business Combination should it occur) is February 2, 2024 pursuant to the Second Special Meeting.

Q.     Why is BlueRiver proposing the Equity Incentive Plan Proposal?

A.     The purpose of the Equity Incentive Plan is to enable the Company to offer eligible employees, directors and consultants cash and other stock-based and other performance-based incentive awards in order to attract, retain and reward these individuals and strengthen the mutuality of interests between them and the Company’s stockholders. For more information, see the section entitled “Proposal 4: The Equity Incentive Plan Proposal.”

Q.     Why is BlueRiver proposing the NYSE Proposal?

A.     We are proposing the NYSE Proposal to comply with Section 712 and Section 713 of the NYSE American listing rules, which requires stockholder approval prior to the issuance of shares of common stock in certain circumstances, including (i) where the number of shares of common stock to be issued could result in an increase in outstanding common stock, or will be upon issuance, equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of the common stock or of securities convertible into or exercisable for common stock or (ii) if any individual director, officer or substantial shareholder of the listed company has a 5% or greater interest (or such persons collectively have a 10% or greater interest), directly or indirectly, in such company or the assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock could result in an increase in outstanding shares of common stock or voting power of 5% or more. BlueRiver currently expects to issue an estimated [•] shares of Class A common stock (including shares of Class A common stock to be issued upon the exchange or conversion of securities to be outstanding upon consummation of the Business Combination), which is in excess of 20% of the number of BlueRiver Shares outstanding before the Business Combination. Also, Randall Mays, BlueRiver’s Co-Chairman, Co-Chief Executive Officer and Chief Financial Officer and one of the two managers of BlueRiver’s Sponsor and a member of the group of Initial Shareholders through certain affiliated entities. In addition, LLM Family Investment Series 44, L.P., for which Mr. Mays serves as Co-Manager of the General Partner and RTM Partners, Ltd., for which Mr. Mays serves as Manager of the General Partner and holds a 49% equity interest, collectively own approximately 13.39% of SST equity interests prior to the Business Combination. Under the NYSE American listing rules, we are required to obtain stockholder approval of such issuances pursuant to Section 712 and Section 713 of the NYSE American listing rules. Stockholder approval of the NYSE Proposal is also a condition to closing in the Purchase Agreement. See the section entitled “NYSE Proposal” for additional information.

Q.     What amendments will be made to the current constitutional documents of BlueRiver?

A.     The consummation of the Business Combination is conditioned, among other things, on the Domestication. Accordingly, in addition to voting on the Business Combination, BlueRiver’s shareholders also are being asked to consider and vote upon a proposal to approve the Conversion Amendment and the Domestication, and replace our Existing Organizational Documents, in each case, under Cayman Islands law with the Proposed Organizational Documents, in each case, under the DGCL, which differ materially from the Existing Organizational Documents in the following respects:

before the effective time of the Merger, each of the then outstanding BlueRiver Warrants will be cancelled and exchanged for 0.075 shares of Surviving Pubco Class A Common Stock. Please see the section entitled “Warrant Holder Proposal 1: The Warrant Amendment Proposal” for additional information.

Q.     Why is BlueRiver proposing the Warrant Holders Adjournment Proposal?

A.     BlueRiver is proposing the Warrant Holders Adjournment Proposal to approve the adjournment of the Warrant Holders Meeting to a later date or dates, if necessary, (a) to permit further solicitation and vote of proxies in the event that there are insufficient votes for the approval of the Warrant Amendment Proposal at the Warrant Holders Meeting or (b) if the BlueRiver Board determines before the Warrant Holders Meeting that it is not necessary or no longer desirable to proceed with the proposals. Please see the section entitled “Warrant Holder Proposal 2: The Warrant Holders Adjournment Proposal” for additional information.

Q.     How do I vote?

A.     If you are a record owner of your shares or warrants, there are two ways to vote your BlueRiver Shares or BlueRiver Warrants at the Special Meetings:

You Can Vote By Signing and Returning the Enclosed Proxy Card.    If you vote by proxy card, your “proxy,” whose name is listed on the proxy card, will vote your shares and/or warrants as you instruct on the proxy card. If you sign and return the proxy card but do not give instructions on how to vote your shares and/or warrants, your shares and/or warrants will be voted as recommended by the BlueRiver Board “FOR” the Business Combination Proposal, the Conversion Amendment Proposal, the Domestication Proposal, the Equity Incentive Plan Proposal, the NYSE American Proposal, the Charter Proposal, each of the Organizational Documents Proposals and the Adjournment Proposal (if presented) at the Shareholders Meeting and “FOR” the Warrant Amendment Proposal and the Warrant Holders Adjournment Proposal (if presented) at the Warrant Holders Meeting. Votes received after a matter has been voted upon at the Special Meetings will not be counted.

You Can Attend the Special Meetings and Vote in Person.    When you arrive, you will receive a ballot that you may use to cast your vote.

If your shares and/or warrants are held in “street name” or are in a margin or similar account, you should contact your broker to ensure that votes related to the shares and/or warrants you beneficially own are properly counted. If you wish to attend the Special Meetings and vote in person and your shares and/or warrants are held in “street name,” you must obtain a legal proxy from your broker, bank or nominee. That is the only way BlueRiver can be sure that the broker, bank or nominee has not already voted your shares and/or warrants.

Q.     What if I do not vote my BlueRiver Shares or if I abstain from voting?

A.     The approval of the Business Combination Proposal, the Equity Incentive Plan Proposal, the Organizational Documents Proposals, the NYSE American Proposal and the Adjournment Proposal will require an ordinary resolution as a matter of Cayman Islands law, being the affirmative vote of a majority, as of the Record Date, of the outstanding BlueRiver Shares that are present and vote at the Shareholders Meeting. The Organizational Documents Proposals are voted upon on a non-binding advisory basis. The Domestication Proposal and the Charter Proposal will require the affirmative vote of the holders of a majority of at least two-thirds, as of the Record Date, of the BlueRiver Shares that are present and vote at the Shareholders Meeting. The Warrant Amendment Proposal will require the affirmative vote of the holders of at least (i) 65% of the outstanding Public Warrants and (ii) 50% of the outstanding Private Placement Warrants, each voting separately as a class. Approval of the Warrant Holders Adjournment Proposal requires the affirmative vote of the holders of at least 50% of the Warrants present in person, online or represented by proxy at the Warrant Holders Meeting, with such votes cast by BlueRiver warrant holders present or represented by proxy and entitled to vote at the Warrant Holders Meeting. Abstentions and broker non-votes will be considered present for the purposes of establishing a quorum. Broker non-votes will not count as votes cast at the Special Meetings and, therefore, will not have any impact on the proposals presented at the Special Meetings. Additionally, with respect to all Shareholder Proposals except for the NYSE American Proposal and the Equity Inventive Plan Proposal, abstentions will not count as votes cast at the Shareholders Meeting and, therefore, will have no effect on the outcome of such proposals. With respect to the NYSE American Proposal and the Equity Inventive Plan Proposal, abstentions will count as a vote “AGAINST” those proposals in accordance with NYSE American listing rules.

Q.     What Proposals must be passed in order for the Business Combination to be completed?

A.     The Business Combination will not be completed unless the Domestication Proposal, the Business Combination Proposal, the Charter Proposal and the NYSE American Proposal are approved. If BlueRiver does not complete an initial business combination (which will be the Business Combination should it occur) by February 2, 2024, BlueRiver will be required to dissolve and liquidate itself and return the monies held within its Trust Account to its Public Shareholders unless BlueRiver submits and its shareholders approve an extension.

Q.     Why is BlueRiver proposing the Organizational Documents Proposals?

A.     BlueRiver is requesting that its shareholders vote upon, on a non-binding advisory basis, proposals to approve certain governance provisions contained in the Certificate of Incorporation that materially affect shareholder rights. This separate vote is not required by Cayman Islands law separate and apart from the Charter Proposal, but pursuant to SEC guidance, BlueRiver is required to submit these provisions to its shareholders separately for approval. However, the shareholder vote regarding this proposal is an advisory vote, and is not binding on BlueRiver and the BlueRiver Board (separate and apart from the approval of the Charter Proposal). Furthermore, the Business Combination is not conditioned on the separate approval of the Organizational Documents Proposals (separate and apart from approval of the Charter Proposal). Please see the section entitled “Proposal 3 — The Organizational Documents Proposals” for additional information.

Q.     How does the BlueRiver Board recommend that I vote on the Shareholder Proposals?

A.     The BlueRiver Board recommends that the holders of BlueRiver’s ordinary shares entitled to vote on the Shareholder Proposals, vote as follows:

“FOR” approval of the Business Combination Proposal;

“FOR” approval of the Conversion Amendment Proposal

“FOR” approval of the Domestication Proposal;

“FOR” approval of the Equity Incentive Plan Proposal;

“FOR” approval of the Charter Proposal;

“FOR” approval of each of the Organizational Documents Proposals;

“FOR” approval of the NYSE American Proposal; and

“FOR” approval of the Adjournment Proposal, if presented.

Q.     How does the BlueRiver Board recommend that I vote on the Warrant Holder Proposals?

A.     The BlueRiver Board recommends that the holders of BlueRiver’s warrants entitled to vote on the Warrant Holder Proposals, vote as follows:

“FOR” approval of the Warrant Amendment Proposal; and

“FOR” approval of the Warrant Holders Adjournment Proposal, if presented.

Q.     How many votes do I have?

A.     BlueRiver shareholders have one vote per each ordinary share of BlueRiver held by them on the Record Date for each of the Shareholder Proposals to be voted upon. BlueRiver warrant holders have one vote per each BlueRiver Warrant held by them on the Record Date for each of the Warrant Holder Proposals to be voted upon.

Q.     How will the Sponsor and BlueRiver’s officers and directors vote in connection with the Shareholder Proposals?

A.      As of the Record Date, the Sponsor and BlueRiver’s independent directors owned of record an aggregate of [•] Class B ordinary shares, representing approximately [•]% of the issued and outstanding BlueRiver Shares. Pursuant to the Sponsor Letter Agreement, the Sponsor and BlueRiver’s directors and officers have agreed to vote

the ordinary shares owned by them (including the Class B ordinary shares) in favor of the Shareholder Proposals. The Sponsor and BlueRiver’s officers and directors, as of the Record Date, have not acquired any BlueRiver Ordinary Shares during or after our IPO in the open market. However, any subsequent purchases of BlueRiver Ordinary Shares prior to the Record Date by the Sponsor or BlueRiver’s officers and directors in the aftermarket will make it more likely that the Shareholder Proposals will be approved as such shares would be voted in favor of the Shareholder Proposals. As of the Record Date, there were [•] ordinary shares of BlueRiver outstanding.

Q:     What interests do the current officers and directors of BlueRiver have in the Business Combination?

A:     When you consider the BlueRiver Board’s recommendation of the Proposals, you should keep in mind that BlueRiver’s officers and directors have interests in the Business Combination that are different from, or in addition to, those of other shareholders generally, including that the Sponsor or BlueRiver’s directors and officers can earn a positive rate of return on their investment, even if other shareholders experience a negative rate of return in the post-business combination company. BlueRiver’s directors were aware of and considered these interests, among other matters, in evaluating the Business Combination, and in recommending to shareholders that they approve the Business Combination. Shareholders should take these interests into account in deciding whether to approve the Business Combination. See “The Business Combination — Interests of the Sponsor and BlueRiver Directors and Officers in the Business Combination” for additional information. The BlueRiver Board was aware of and considered these interests, among other matters, in recommending that BlueRiver shareholders vote “FOR” each of the Proposals. These interests include, among other things:

•        the fact that the Sponsor holds 800,000 units acquired at a purchase price of $8,000,000, or $10.00 per unit, which include 800,000 Private Placement Shares and 266,667 Private Placement Warrants;

•        the fact that the Sponsor and BlueRiver’s officers and directors have agreed not to redeem any BlueRiver Class A Ordinary Shares held by them in connection with a shareholder vote to approve the Business Combination;

•        the fact that the Sponsor paid an aggregate of $25,000, or approximately $0.0035 per share, for 7,187,500 BlueRiver Founder Shares, 90,000 shares of which were subsequently transferred by the Sponsor to BlueRiver’s independent directors and advisors, and all of which are subject to certain transfer restrictions as described in this proxy statement/prospectus and that such remaining BlueRiver Founder Shares could have a significantly higher value at the time of the Business Combination, which if unrestricted and freely tradable would be valued at approximately $75.5 million, based on the most recent closing price of the BlueRiver Class A Ordinary Shares of $10.50 per share on November 8, 2023;

•        the fact that Randall Mays and John Gregg are managers of BlueRiver and of the Sponsor and each may be deemed to have or share beneficial ownership of the BlueRiver Founder Shares held directly by the Sponsor;

•        the fact that Mr. Mays is the Co-Manager of the General Partner of LLM Family Investment Series 44, L.P. and the Manager of the General Partner of RTM Partners, Ltd., which collectively own approximately 13.39%, or [_____] membership units, of SST equity interests prior to the Business Combination. As a result of the foregoing, Mr. Mays may be deemed to have a significant influence over SST and conflicts of interest in the Business Combination with SST;

•        the fact that RTM Partners II, Ltd., an entity controlled by Randall Mays, will hold a promissory note, which will have a principal amount of up to $3.0 million, will bear interest at a rate of 8.0% per annum, and will mature on the earliest to occur of (i) the completion of the Business Combination, (ii) the completion of another financing transaction, (iii) the completion of a change of control transaction, and (iv) April 30, 2024. The note financing will close [in early 2024] and such promissory note will be repaid in connection with the closing of the Business Combination;

•        if the Trust Account is liquidated, including in the event BlueRiver is unable to complete an Initial Business Combination within the required time period, the Sponsor has agreed to indemnify BlueRiver to ensure that the proceeds in the Trust Account are not reduced below $10.00 per Public Share, or such lesser amount per Public Share as is in the Trust Account on the liquidation date, by the claims of (a) any third party (other than BlueRiver’s independent registered public accounting firm) for services rendered or products sold to BlueRiver or (b) a prospective target business with which BlueRiver has entered into a letter of intent, confidentiality or other similar agreement or business combination agreement, but only if such a third party or target business has not executed a waiver of all rights to seek access to the Trust Account;

•        the fact that BlueRiver’s independent directors and advisors own an aggregate of 90,000 BlueRiver Founder Shares that were transferred from the Sponsor at their original purchase price, or approximately $0.0035 per share, or $315, which if unrestricted and freely tradeable would be valued at approximately $945,000, based on the most recent closing price of the BlueRiver Class A Ordinary Shares of $10.50 per share on November 8, 2023;

•        the fact that the Sponsor and BlueRiver’s officers, and directors may be incentivized to complete the Initial Business Combination, or an alternative initial business combination with a less favorable company or on terms less favorable to stockholders, rather than to liquidate, in which case the Sponsor and BlueRiver’s officers, and directors would lose their entire investment. As a result, the Sponsor and BlueRiver’s officers, and directors may have a conflict of interest in determining whether SST is an appropriate business with which to effectuate a business combination and/or in evaluating the terms of the Initial Business Combination;

•        the fact that the Sponsor and BlueRiver’s officers, directors and advisors will lose their entire investment in BlueRiver if an Initial Business Combination is not completed within the Combination Period; and

•        in addition to these interests of the Sponsor and BlueRiver’s officers, directors and advisors, to the fullest extent permitted by applicable laws, the Existing Organizational Documents waives certain applications of the doctrine of corporate opportunity in some circumstances where the application of any such doctrine would conflict with any fiduciary duties or contractual obligations they may have as of the date of the Existing Organizational Documents or in the future, and BlueRiver will renounce any expectancy that any of the directors or officers of BlueRiver will offer any such corporate opportunity of which he or she may become aware to BlueRiver. BlueRiver does not believe that the pre-existing fiduciary duties or contractual obligations of its officers and directors materially impacted its search for an acquisition target. Further, BlueRiver does not believe that the waiver of the application of the corporate opportunity doctrine in the Existing Organizational Documents had any impact on its search for a potential business combination target.

As a result of the lower price paid by our initial shareholders for their BlueRiver Founder Shares, the initial shareholders may generate a profit on those shares even at prices that would generate a significant loss for the Public Shareholders on their Public Shares. For more information regarding certain conflicts of interests of Prime Impact and its affiliates relating to the Business Combination and Proposals to be presented at the extraordinary general meeting, see “The Business Combination — Interests of the Sponsor and Prime Impact Directors and Officers in the Business Combination.”

The Class A Ordinary Shares to be received by the Sponsor in exchange of the BlueRiver Founder Shares will be subject to a contractual lockup. Based on the most recent closing price of the BlueRiver Class A Ordinary Shares of $10.50 per share on November 8, 2023, these shares would be worth approximately $75.5 million.

Q.     Do I have Redemption Rights with respect to my BlueRiver Shares?

A.     Under Section 8.1 of the Amended and Restated Memorandum and Articles of Association, prior to the completion of the Business Combination, BlueRiver will provide all of the Public Shareholders with the opportunity to have their shares redeemed upon the completion of the Business Combination, subject to certain limitations, for cash equal to the applicable redemption price; provided, however, that BlueRiver may not redeem such shares to the extent that such Redemption would result in BlueRiver having net tangible assets (as determined under the Exchange Act) of less than $5,000,001 upon the completion of the Business Combination.

Public Shareholders may seek to have their shares redeemed regardless of whether they vote for or against the Business Combination, whether or not they were holders of BlueRiver Ordinary Shares as of the Record Date or acquired their shares after the Record Date. The Redemptions will be effectuated in accordance with the Amended and Restated Memorandum and Articles of Association and Cayman Islands law. Any Public Shareholder who holds ordinary shares of BlueRiver on or before [•], 2024 (two business days before the Shareholders Meeting) will have the right to demand that his, her or its shares be redeemed for a pro rata share of the aggregate amount then on deposit in the Trust Account, less any taxes then due but not yet paid, at the completion of the Business Combination; provided that such Public Shareholders follow the procedures provided for exercising such Redemption as set forth in the Amended and Restated Memorandum and Articles of Association, as described below, by such date. However, the proceeds held in the Trust Account could be subject to claims that could take priority over those of Public Shareholders exercising Redemption Rights,

regardless of whether such holders vote for or against the Business Combination Proposal and whether such holders are holders of BlueRiver Ordinary Shares as of the Record Date. Therefore, the per-share distribution from the Trust Account in such a situation may be less than originally anticipated due to such claims. A Public Shareholder will be entitled to receive cash for these shares only if the Business Combination is completed. For more information, see “Shareholders Meeting — Redemption Rights.”

Pursuant to the Sponsor Support Agreement, the Sponsor and certain directors and officers of BlueRiver have agreed to waive their redemption rights with respect to all of the BlueRiver ordinary shares held by them in connection with the consummation of the Business Combination. Such shares will be excluded from the pro rata calculation used to determine the per-share redemption price. No specific consideration was ascribed to the waiver of redemption rights in the Sponsor Support Agreement.

Q.     May the Sponsor, BlueRiver’s directors, officers, advisors or their affiliates purchase shares in connection with the Business Combination?

A.      The Sponsor and BlueRiver’s directors, officers, advisors or their affiliates may purchase BlueRiver Shares in privately negotiated transactions or in the open market either prior to or after the Closing, including from BlueRiver shareholders who would have otherwise exercised their Redemption Rights. However, the Sponsor, directors, officers and their affiliates have no current commitments or plans to engage in such transactions and have not formulated any terms or conditions for any such transactions at the date of this proxy statement/prospectus. If BlueRiver engages in such transactions, any such purchases will be subject to limitations regarding possession of any material nonpublic information not disclosed to the seller of such shares and they will not make any such purchases if such purchases are prohibited by Regulation M under the Exchange Act. Any such purchase after the Record Date would include a contractual acknowledgement that the selling shareholder, although still the record holder of BlueRiver Shares, is no longer the beneficial owner thereof and therefore agrees not to exercise its Redemption Rights. In the event the Sponsor or BlueRiver’s directors, officers or advisors or their affiliates purchase shares in privately negotiated transactions from Public Shareholders who have already elected to exercise their Redemption Rights, such selling shareholders would be required to revoke their prior elections to redeem their shares. Any such privately negotiated purchases may be effected at purchase prices that are in excess of the per-share pro rata portion of the aggregate amount then on deposit in the Trust Account. None of the funds in the Trust Account will be used to purchase Public Shares in such transactions. None of the Sponsor, or BlueRiver’s directors, officers, advisors, or any of their respective affiliates will make any such purchases when they are in possession of any material non-public information not disclosed to the seller of such public shares or during a restricted period under Regulation M under the Exchange Act.

Q.     Is there a limit on the number of shares I may redeem?

A.     Each Public Shareholder, together with any affiliate or any other person with whom such Public Shareholder is acting in concert or as a “group” (as defined in Section 13(d)(3) of the Exchange Act), will be restricted from seeking Redemption Rights with respect to 15% or more of the Public Shares. Accordingly, any shares held by a Public Shareholder or “group” in excess of such 15% cap will not be redeemed by BlueRiver. Any Public Shareholder who holds less than 15% of the Public Shares may have all of the Public Shares held by him or her redeemed for cash.

Q.     How do I exercise my Redemption Rights?

A.     If you are a Public Shareholder and you seek to have your shares redeemed, you must (i) demand, no later than 5:00 p.m., Eastern Time, on            , 2024 (two business days before the Shareholders Meeting), that BlueRiver redeem your shares for cash, (ii) affirmatively certify in your request to BlueRiver’s Transfer Agent for Redemption if you “ARE” or “ARE NOT” acting in concert or as a “group” (as defined in Section 13d-3 of the Exchange Act) and (iii) submit your request in writing to BlueRiver’s Transfer Agent, at the address listed at the end of this section and deliver your share certificates (if any) and other redemption forms to BlueRiver’s Transfer Agent physically or electronically using The Depository Trust Company’s DWAC system at least two business days prior to the vote at the Shareholders Meeting.

Any request for Redemption, once made by a Public Shareholder, may not be withdrawn once submitted to the company unless the Board of Directors of the company determine (in their sole discretion) to permit the withdrawal of such redemption request (which they may do in whole or in part). In addition, if you deliver your share certificates (if any) and other redemption forms for Redemption to BlueRiver’s Transfer Agent and later

Q.     If I am a holder of BlueRiver Warrants, can I exercise Redemption Rights with respect to my Warrants?

A.     No. The holders of BlueRiver Warrants have no redemption rights with respect to BlueRiver Warrants. Assuming the maximum redemption scenario representing the redemption of all Public Shares and based on the closing price of such BlueRiver Warrants of $             on Nasdaq as of             , 2024, the aggregate value that can be retained by BlueRiver shareholders who have properly exercised their Redemption Rights is $            . The actual market price of the BlueRiver Warrants may be higher or lower on the date that a holder of BlueRiver Warrants seeks to sell or exercise such BlueRiver Warrants. Additionally, BlueRiver cannot assure the holders of BlueRiver Warrants that they will be able to sell their BlueRiver Warrants in the open market as there may not be sufficient liquidity in such BlueRiver Warrants when a holder thereof desires to sell. Further, while the level of BlueRiver Share Redemption will not directly change the value of the BlueRiver Warrants, as the BlueRiver Warrants will remain outstanding regardless of the level of redemptions, as redemptions of BlueRiver Ordinary Shares increase, a holder of BlueRiver Warrants will ultimately own a greater interest in BlueRiver (or, after completion of the Business Combination, the Surviving Pubco) because there would be fewer BlueRiver Ordinary Shares (or, after completion of the Business Combination, the Surviving Pubco Class A Common Stock) outstanding overall. For additional information see “— Ownership of the Post-Business Combination Company After the Closing.”

Q.     What are the risks for the holders of the BlueRiver Warrants?

A.     If the Warrant Amendment is not approved, BlueRiver has the ability to redeem outstanding warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last sale price of our Class A ordinary shares or Class A common stock, as applicable, equals or exceeds $18.00 per share (as adjusted for share splits, share capitalizations, reorganizations, recapitalizations and the like) on each of 20 trading days within a 30 trading-day period ending on the third trading day prior to the date on which notice of such redemption is given. Please note that the closing price of our Class A ordinary shares has not exceeded $18.00 per share for any of the 30 trading days prior to the date of this Registration Statement. We will not redeem the warrants unless an effective registration statement under the Securities Act covering the Class A common stock issuable upon exercise of the warrants is effective and a current prospectus relating to those Class A common stock is available throughout the 30-day redemption period, except if the warrants may be exercised on a cashless basis and such cashless exercise is exempt from registration under the Securities Act. If and when the warrants become redeemable by us, we may exercise our redemption right even if we are unable to register or qualify the underlying securities for sale under all applicable state securities laws.

Redemption of the outstanding warrants could force you to (i) exercise your warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so, (ii) sell your warrants at the then-current market price when you might otherwise wish to hold your warrants or (iii) accept the nominal redemption price which, at the time the outstanding warrants are called for redemption, is likely to be substantially less than the market value of your warrants. None of the Private Placement Warrants will be redeemable by us so long as they are held by their initial purchasers or their permitted transferees.

In addition, if the Warrant Amendment is not approved, we may redeem your warrants after they become exercisable for a number of Class A ordinary shares or Class A common stock, as applicable, determined based on the redemption date and the fair market value of our Class A ordinary shares or Class A common stock, as applicable. Any such redemption may have similar consequences to a cash redemption described above. In addition, such redemption may occur at a time when the warrants are “out-of-the-money,” in which case you would lose any potential embedded value from a subsequent increase in the value of the Class A ordinary shares or Class A common stock, as applicable, had your warrants remained outstanding.

In the event that we elect to redeem all of the redeemable warrants, we will fix a date for the redemption. Pursuant to the terms of the warrant agreement, notice of redemption will be mailed by first class mail, postage prepaid, by the Company not less than 30 days prior to the redemption date to the registered holders of the redeemable warrants to be redeemed at their last addresses as they appear on the registration books. Any notice mailed in the manner provided in the warrant agreement will be conclusively presumed to have been duly given whether or not the registered holder received such notice.

RISK FACTORS

Following the completion of the Business Combination, Surviving Pubco will operate in a market environment that is difficult to predict and that involves significant risks, many of which will be beyond its control. You should carefully consider the risks described below before voting your shares. Additional risks and uncertainties that are not presently known to SST and BlueRiver or that they do not currently believe are important to an investor, if they materialize, also may adversely affect the Business Combination. If any of the events, contingencies, circumstances or conditions described in the following risks actually occur, Surviving Pubco’s business, financial condition or results of operations could be seriously harmed. If that happens, the trading price of Surviving Pubco’s securities or, if the Business Combination is not consummated, BlueRiver Class A Shares could decline, and you may lose part or all of the value of any Class A ordinary shares or, if the Business Combination is not consummated, all or any part of the value of any BlueRiver Class A Shares that you hold.

Risks Related to SST’s Business and Surviving Pubco Following the Business Combination

Throughout this section, unless otherwise indicated or the context otherwise requires, references in this section to “SST,” “we,” “us,” “our” and other similar terms refer to SST and its subsidiaries prior to the Business Combination and to the Surviving Pubco and its consolidated subsidiaries after giving effect to the Business Combination.

We have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.

We are a clinical stage medical device company with a limited operating history, and we have incurred significant net losses since our inception in 2013. We incurred net losses of approximately $6.1 and $3.6 for the nine months ended September 30, 2023 and 2022, respectively, and net losses of approximately, $4.8 million and $4.7 million for the years ended December 31, 2022 and 2021, respectively. As of September 30, 2023 and December 31, 2022, we had an accumulated deficit of $48.6 and $42.5 million, respectively. We have funded our operations to date primarily with proceeds from the sale of our equity securities in private financing transactions. We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continues our development of, and seek the necessary regulatory approvals for our product candidate, as well as hire additional personnel, pay fees to outside consultants, attorneys and accountants, and, if the planned merger is consummated, incur other increased costs associated with being a public company. In addition, if and when we obtain regulatory approval to conduct a clinical trial of our product candidate, the PerQdisc, in the United States, we will also incur increased expenses in what would be the first in human clinical trial for its product in the US.

We have no products approved for commercial sale and we are devoting, and expect to continue devoting, substantially all our financial resources and efforts to the continued development of our PerQdisc product candidate, investments in training and educating surgeons and other healthcare providers, clinical and regulatory matters for our products, and developing manufacturer and supplier relationships. Investment in medical device development, especially clinical stage products, is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will not successfully undergo or complete necessary clinical trials, fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.

We expect that it could take several years until any of our product candidates, which at present is solely PerQdisc and the tool kit used by surgeons to prepare the disc space for PerQdisc, receive regulatory and marketing approval and are commercialized, and we may never be successful in obtaining regulatory and marketing approval and commercializing product candidates. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our stockholders’ equity and net assets and may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

•        continue our ongoing and planned research and development activities for our PerQdisc device;

•        continue preclinical studies and initiate future clinical trials for PerQdisc;

•        seek to discover and develop additional product candidates and further expand our product pipeline;

•        seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;

•        establish sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidate for which we may obtain regulatory approval;

•        develop and refine the manufacturing process for our product candidates;

•        change or add additional manufacturers or suppliers and scale up our internal manufacturing program;

•        establish or supplement relationships with contract development and manufacturing organizations (“CDMOs”), contract research organizations (“CROs”), and other third party collaborators;

•        develop, maintain, expand and protect our intellectual property portfolio;

•        add clinical, quality control, manufacturing, operational, financial and management information systems personnel, including personnel to support our product development and planned future commercialization efforts; and

•        incur additional legal, accounting and other expenses associated with operating as a public company.

Because of the numerous risks and uncertainties associated with the development, manufacturing, delivery and commercialization of spinal stabilization devices, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical trials or ongoing research and development activities, our expenses could increase, and profitability could be further delayed.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our securities and could impair our ability to raise capital, maintain our research and development efforts, accomplish our strategic objectives, or continue our operations. A decline in the value of our securities could also cause you to lose all or part of your investment.

We have not generated any revenue and may never be profitable.

To become and remain profitable, we must succeed in developing and eventually commercializing products that generate significant revenue. To date, we have not generated any revenue. Our sole product candidate, PerQdisc, is in the early clinical stage of development. We do not expect to generate significant revenue unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, our PerQdisc Nucleus Replacement System, which we do not expect to occur for several years.

This will require us to be successful in a range of challenging activities, including, but not limited to, our ability to:

•        successfully complete additional preclinical studies, clinical trials and safety studies for PerQdisc and the associated tool kit to prepare the disc space for the implant, which are required to obtain U.S. and applicable foreign marketing approval;

•        prepare satisfactory submissions for regulatory authorities, and respond to additional demands from regulators;

•        timely file and receive acceptance of an investigational device exemption application (“IDE”), and amendments thereto, as applicable, in order to commence our planned and future clinical trials;

•        reinstate our CE Mark in the EU, because our CE certificate was suspended in September 2022, which may require additional clinical data;

•        successfully enroll subjects in, and complete, clinical trials for PerQdisc;

•        hire additional staff, including clinical, scientific and management personnel and marketing and sales personnel or consultants;

•        if we receive regulatory approvals, maintain a continued acceptable safety profile of our product candidate following such approvals;

•        obtain and maintain acceptance of PerQdisc, if and when approved, by patients, the medical community and third-party payors;

•        establish sufficient commercial manufacturing capabilities through third-party manufacturers, suppliers, vendors and CDMOs for clinical supply and commercial manufacturing of our product candidates;

•        obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidate;

•        launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;

•        position our product to effectively compete with other medical devices and therapies;

•        obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidate, and obtain favorable physician payments so the medical community will be comfortable offering the PerQdisc to eligible patients;

•        enforce and defend intellectual property rights and claims with respect to our product candidate; and

•        discovering and developing additional product candidates in the future.

These activities will require significant investments. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Moreover, many of the factors listed above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercialize our existing or future product candidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soon after generating product sales, if ever. If we are unable to generate sufficient revenue through the sale of PerQdisc or any future product candidates, we may be unable to continue operations without continued funding.

Surviving Pubco will be a holding company and its only material asset after completion of the Business Combination will be its interest in SST, and it is accordingly dependent upon distributions made by its subsidiaries to pay taxes and pay dividends.

Upon completion of the Business Combination, the Surviving Pubco will be a holding company with no material assets other than its ownership of the Surviving Company Common Units and its managing member interest in SST. As a result, the Surviving Pubco will have no independent means of generating revenue or cash flow. The Surviving Pubco’s ability to pay taxes and pay dividends will depend on the financial results and cash flows of SST and the distributions it receives from SST. Deterioration in the financial condition, earnings or cash flow of SST for any reason could limit or impair SST’s ability to pay such distributions. Additionally, to the extent that the Surviving Pubco needs funds and v are restricted from making such distributions under applicable law or regulation or under the terms of any financing arrangements, or SST is otherwise unable to provide such funds, it could materially adversely affect the Surviving Pubco’s liquidity and financial condition.

SST will continue to be treated as a partnership for U.S. federal income tax purposes and, as such, generally will not be subject to any entity-level U.S. federal income tax. Instead, taxable income will be allocated to holders of SST Common Units. Accordingly, the Surviving Pubco will be required to pay income taxes on its allocable share of any net taxable income of SST. Under the terms of the LLCA, SST is obligated to make tax distributions to holders of SST Common Units (including the Company) calculated at certain assumed tax rates. The Surviving Pubco intends to cause SST to make ordinary distributions and tax distributions to holders of SST Common Units on a pro rata basis in amounts sufficient to cover all applicable taxes, relevant operating expenses and dividends, if any, declared by the Company. However, as discussed below, SST’s ability to make such distributions may be subject

to various limitations and restrictions including, but not limited to, retention of amounts necessary to satisfy the obligations of SST and restrictions on distributions that would violate any applicable restrictions contained in any future SST debt agreement, or any applicable law, or that would have the effect of rendering SST insolvent.

Additionally, although SST generally will not be subject to any entity-level U.S. federal income tax, it may be liable for adjustments to its tax return, absent an election to the contrary arising out of audits of its tax returns for 2022 and subsequent years. In the event SST’s calculations of taxable income are incorrect, SST and/or its members, including the Surviving Pubco, in later years may be subject to material liabilities.

Dividends on the Company’s common stock, if any, will be paid at the discretion of the Surviving Pubco Board, which will consider, among other things, the Company’s available cash, available borrowings and other funds legally available therefor, taking into account the retention of any amounts necessary to satisfy the obligations of the Surviving Pubco that will not be reimbursed by SST, including any restrictions in then applicable bank financing agreements. Financing arrangements may include restrictive covenants that restrict the Surviving Pubco’s ability to pay dividends or make other distributions to its stockholders. In addition, SST is generally prohibited under Delaware law from making a distribution to a member to the extent that, at the time of the distribution, after giving effect to the distribution, liabilities of SST (with certain exceptions) exceed the fair value of its assets. SST’s subsidiaries are generally subject to similar legal limitations on their ability to make distributions to SST. If SST does not have sufficient funds to make distributions, the Surviving Pubco’s ability to declare and pay cash dividends may also be restricted or impaired.

SST’s management has determined that SST lacks the financing required to sustain operations for a reasonable period of time, which raises substantial doubt about SST’s ability to continue as a going concern, and we cannot assure you that consummation of the Business Combination will eliminate this concern.

Our management team has determined that we lack the financing required to sustain operations for a reasonable period of time, which raises substantial doubt about our ability to continue as a going concern, as set forth in our notes to financials included elsewhere in this proxy statement/prospectus. There is no assurance that sufficient financing will be available when needed, or at all, to allow us to continue as a going concern.

The substantial doubts about SST’s ability to continue as a going concern relate primarily to its current cash on hand, recurring losses from operations since inception, access to capital and the future cash needed to continue to operate as a going concern. SST’s ability to continue as a going concern is dependent on various factors, and neither SST nor BlueRiver can assure you that the consummation of the Business Combination will eliminate any doubts about SST’s ability to continue as a going concern. For example, if holders of BlueRiver Class A Shares elect to redeem shares in an amount that is above what BlueRiver expects, there may be less cash available to SST at the consummation of the merger than expected. If SST is unable to continue as a going concern, it may be forced to sell assets, seek bankruptcy relief or otherwise restructure its balance sheet or liquidate and you could lose all or a substantial portion of your investment.

In addition, the substantial doubt as to our ability to continue as a going concern could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. The perception that we may not be able to continue as a going concern may also make it more difficult to operate the business due to concerns about our ability to meet its contractual obligations. Our ability to continue as a going concern is contingent upon, among other factors, the satisfaction of closing conditions for the Business Combination relating to Net Tangible Assets and Available Cash, which are defined in the Merger Agreement and discussed elsewhere in this prospectus, or obtaining alternate financing. We cannot provide any assurance that we will be able to raise additional capital.

If we are unable to secure additional capital, we may be required to curtail our clinical and research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our clinical and regulatory efforts, which is critical to the realization of our business plan. The accompanying consolidated financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. It is not possible for us to predict at this time the potential success of our business. The revenue and income potential of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all of your investment.

Our limited operating history makes it difficult to evaluate our business and assess our future viability and prospects.

We are a clinical stage company with a limited operating history. We commenced operations in 2013, and our operations to-date have been limited to organizing and planning our development efforts, raising capital, conducting discovery and research activities, filing patent applications, undertaking preclinical and clinical studies, and establishing arrangements with third parties for the manufacture of initial quantities of our PerQdisc device. Our completed clinical trials to-date have been conducted outside of the U.S. and have been limited in size. We have not yet demonstrated our ability to successfully complete any registrational clinical trials, obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.

Our business is highly dependent on the success of our sole product candidate, PerQdisc. If we are unable to successfully complete clinical development of, obtain regulatory approval for and successfully commercialize PerQdisc for the treatment of patients in approved indications, or if we experience delays in doing so, our business will be materially harmed.

Our business and future success depends on our ability to advance clinical development, obtain regulatory approval of, and then successfully commercialize our surgical implant system, PerQdisc, which is our sole product candidate. We have not identified other potential product candidates outside of PerQdisc, nor have we identified indications beyond the treatment of moderate to severe discogenic low back pain. Unlike spinal fusion surgery, patient candidates for nucleus replacement cannot present with previous spinal injuries, tumors or infections.

Other companies’ nucleus replacement spinal implants have not succeeded in effectiveness or commercialization. The failure of PerQdisc, or the failure of other spinal implant technologies, including for reasons due to safety, efficacy or durability, may impede our ability to develop our product candidates, and significantly influence physicians’, regulators’, and payors’ opinions with regard to the viability of our entire product offering.

Our silicone implant and the accompanying implementation instruments will require additional non-clinical and clinical development, regulatory review and clearance or approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. If PerQdisc encounters safety issues, efficacy problems, manufacturing problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed.

To date, we have not yet completed any registrational clinical trials that would provide sufficient data and results to support the filing of an application for United States Food and Drug Administration (“FDA”) approval for marketing PerQdisc. In the EU, although we obtained a CE certificate from our notified body and therefore affixed a CE mark to our PerQdisc Nucleus Replacement System Implant in 2021, which would allow commercialization of our PerQdisc device in that region, the indication was limited to replacing the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single level discogenic pain, and our CE certificate was suspended in September 2022 after only limited commercial activity, meaning that we cannot, while the suspension remains in place, affix a CE mark and commercialize our PerQdisc device in the EU.

We plan to continue to work with our notified body to remove the suspension of our CE certificate in the EU, and we may in the future pursue expanded indications, but there is no guarantee that we will be successful in either endeavor. In order to remove the suspension of our CE certificate, our notified body has confirmed that it

requires compliance with challenging patient consent and data requirements analogous to those required under the MDR. If we are unable to reinstate our CE mark, we will need to re-file and receive approval for a new CE mark, which would require us to comply with challenging MDR requirements. Obtaining and maintaining the CE mark is a significant event upon which our business strategy depends. We will not be able to commercialize PerQdisc in the EU unless or until we achieve this clearance.

We will need substantial additional financing to continue developing PerQdisc and implement our operating plans, which financing we may be unable to obtain, or unable to obtain on acceptable terms. If we fail to obtain additional financing, we may be unable to consummate the Business Combination or complete the development and commercialization of our product candidate.

The closing of the Business Combination is subject to the satisfaction of a condition that BlueRiver have over $5.0 million in net tangible assets remaining after the closing of the BlueRiver Share Redemption (as defined in the Merger Agreement) and that Available Cash (as defined in the Merger Agreement) is equal to or greater than $10.0 million. BlueRiver intends to satisfy such conditions in part through new equity financing conducted through a private placement of its common stock, but such financing remains uncertain. BlueRiver may be unable to secure such financing on acceptable terms or at all, or in an amount sufficient to satisfy the closing condition. If BlueRiver is unable to raise additional capital through new financing sources, and in the event that we are unable to secure additional financing and the closing condition is waived by either party, we may have insufficient capital to operate our business following the closing of the Business Combination and the Surviving Pubco would have total liabilities of $3.5 million (assuming no Public Shareholders exercise redemption rights) or $8.1 million (assuming maximum redemptions of Class A Ordinary Shares).

In addition, we expect to spend a substantial amount of capital in the development and manufacturing of PerQdisc, and we will need substantial additional financing to do so. In particular, we will require substantial additional financing to enable commercial production of PerQdisc, train surgeons and other healthcare providers on our surgical implant system, and initiate and complete registrational trials in multiple regions. Further, if approved, we will require significant additional capital in order to launch and commercialize our surgical implant system. Our expected future capital requirements depend on many factors including expanding our surgeon base, the expansion of our sales force, investment in implants and instruments, scaling manufacturing, and the timing and extent of spending on the development of our technology to increase our product offerings.

As of September 30, 2023, SST had approximately $2.6 million in cash and cash equivalents. Changing circumstances may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control. We may also need to raise additional capital sooner than we currently anticipate if we choose to expand more rapidly than we presently plan. In any event, we will require additional capital for the further development and commercialization of our product candidates, including funding our internal manufacturing capabilities.

We cannot be certain that additional funding will be available on acceptable terms, on a timely basis, or at all. We have no committed source of additional capital. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives. We could be required to seek collaborators for our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our product candidate in markets where we otherwise would seek to pursue development or commercialization ourselves.

Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.

Until such time, if ever, as we can generate substantial revenue from the sale of PerQdisc, we will need substantial additional financing to develop our product candidate and implement our operating plans. We cannot be certain that additional funding will be available on acceptable terms, if at all. If we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need to curtail planned activities to reduce costs, which will likely harm our ability to execute on our business plan and continue operations.

Due to inflationary and market factors, equity and debt capital have become substantially more expensive and difficult to raise on attractive terms, especially with respect to securities issued by companies in the medical device and technology sectors. Accordingly, future debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt offerings. If we raise additional funds by issuing equity securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Any future debt or preferred equity financing may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation or asset sale transactions.

In addition, if we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our research programs or product candidates or grant licenses on terms that may not be favorable to us or that may be at less than the full potential value of such rights. If we are unable to raise additional funds through equity or debt financings or other arrangements with third parties when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Nucleus replacement is a novel treatment method for chronic discogenic low back pain, which creates significant challenges for us.

PerQdisc is a novel product candidate and the use of nucleus replacement as a potential treatment for low back pain is nascent. We will face significant challenges in further advancing our surgical implant system, including:

•        manufacturing our product candidate to our or regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization;

•        sourcing clinical and, if approved, commercial supplies for the raw materials used to manufacture our product candidate;

•        establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a new treatment option;

•        educating surgeons, other medical professionals, and patients about the conditions that PerQdisc is approved to treat, and about its benefits, contraindications, and potential adverse side effects; and

•        educating surgeons on proper placement technique for PerQdisc, as device performance is heavily dependent on implant positioning.

Clinical development involves a complex, lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

To obtain and maintain the requisite regulatory approvals to commercialize any medical devices, we must demonstrate through complex clinical studies and clinical trials that such device is safe and effective in humans. For example, unless an exemption applies, each medical device we wish to commercially distribute in the United States will require either clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which is commonly referred to as premarket notification, or 510(k), clearance, or approval of a premarket approval (“PMA”) application from the FDA.

Clinical trials are generally required to support a PMA application and are sometimes required for 510(k) clearance. The PerQdisc, which includes the disc access system, imaging balloons, implant delivery device, implant fill device, and cartridge dispensing gun, will be considered an implantable device that requires approval of a PMA application. For the rongeur devices that are used in connection with PerQdisc, we expect to initially pursue FDA marketing authorization through the 510(k) process.

In order to conduct the registrational clinical trial that will be required to obtain PMA approval, we must either show that the device presents a nonsignificant risk or obtain an investigational device exemption application (“IDE”). An IDE must be approved in advance by the FDA for a specified number of subjects that are specifically identified in a trial protocol, and a specific number of patients. We are currently preparing to submit an IDE to the FDA, which, if approved, would be our first clinical trial in the United States.

The FDA process for gaining approval for an IDE trial is complex, unpredictable, and time consuming. The FDA may change the requirements needed to be met to gain IDE approval, or the FDA may release new standards or test requirements the company must comply with to gain approval for the trial. In addition to the potential for evolving legal requirements, IDE approval standards may change due to internal FDA changes, such as changes to personnel or policies, and we may not have notice or visibility into whether certain conditions will become subject to change. For example, in the past we have experienced delays in the review process due to turnover in FDA staff reviewers.

We do not know when, or if, we will gain FDA approval for our IDE trial. We plan to make a number of required submissions to the FDA in the fourth quarter of 2023. The exact timing of these submission is unknown and relies on numerous vendors and consultants to complete complex workstreams on time. The timeline may change substantially over the next several months and during the course of the approval process, which could take years.

Changes to EU regulatory requirements could delay or prevent our ability to commercialize PerQdisc in the EU.

The medical device industry has faced significant regulatory changes in recent years, with global regulatory authorities either changing or adding significant new regulations and requirements. For example, in the EU, the more stringent requirements under the MDR, including the requirement for a post-market clinical follow-up (“PMCF”) program that applies to certain medical devices, including Class IIb implantable medical devices and Class III devices, means a higher threshold must now be met in order to commercialize a device in the EU.

Our PerQdisc CE certificate, which we obtained from our notified body, GMED, LNE, in May 2021, was suspended in September 2022, which means we can no longer affix the CE mark to our device. We plan to continue to work with our notified body to release the suspension of our CE certificate in the EU, but there is no guarantee that we will be successful or on what timing. In order to remove such suspension, our notified body has confirmed that it requires clinical follow-up data (including data with a statistically relevant number of subjects, a follow-up period and target patient population adapted to the device and the technique) in order to reinstate it, which will present challenging patient consent and record-keeping requirements, which presents challenging patient consent and data requirements.

Even if our notified body agrees that our CE mark may be reinstated, as our original CE certificate was issued under the MDD (which has now been revoked and replaced by the MDR), our device must be re-assessed for conformity with the MDR before the expiration of the transition period in order for us to continue to be able to place our product on the market. The PerQdisc device is a class IIb implantable medical device under the MDD. Class IIb implantable medical devices lawfully placed on the market pursuant to the MDD prior to May 26, 2021 may generally continue to be made available on the market or put into service until, at the latest, 31 December 2027, provided certain requirements under the MDR are fulfilled (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies). This application process for certification under the MDR may also require further clinical investigations and a new conformity assessment must be conducted by our notified body to confirm compliance with the MDR. Given the expanded scope of medical devices that require notified body review and approval under the MDR, we expect that our notified body will face resource limitations. Accordingly, our ability to re-file and obtain CE mark under the MDR is a highly uncertain process and is likely to require substantial additional time and expense.

We will not be able to market or commercialize PerQdisc in the EU unless or until we achieve this clearance. There is no guarantee that we will be able to convince our notified body to remove the suspension of PerQdisc’s CE certificate.

Even if we receive regulatory approval to initiate our clinical trials, the results of the clinical trials may not support our product candidate claims, and the trials may result in the occurrence of adverse events.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. We may be unable to establish or achieve primary and secondary clinical endpoints that applicable regulatory authorities would consider clinically meaningful, and a clinical trial can fail at any stage of testing. Differences in trial design between early-stage clinical trials and later-stage clinical trials mean that the results of earlier clinical trials may differ from those in later clinical trials. Our completed clinical trials to-date have been limited in size.

Our product candidate may ultimately fail to show the desired safety and efficacy in clinical settings despite positive results in preclinical studies or having successfully advanced through initial clinical trials. It is also possible that patients enrolled in clinical trials will experience adverse events that are not currently part of the product candidate’s profile. Failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidate.

In addition, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.

Clinical trials also are subject to extensive monitoring, recordkeeping and reporting requirements. Clinical trials must be conducted under the oversight of an institutional review board (“IRB”), and the relevant clinical trial sites must comply with FDA regulations, including but not limited to those relating to Good Clinical Practice (“GCP”) requirements. To conduct a clinical trial, we also are required to obtain the subjects’ informed consent that complies with both FDA requirements and state and federal privacy and human subject protection regulations. We, the FDA, or the IRB, could suspend a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and effectiveness of the device or may otherwise not be sufficient to obtain FDA clearance or approval to market the product in the United States. Similarly, in Europe and other countries the clinical study must be approved by a local ethics committee and in some cases, including studies with high- risk devices, by the ministry of health in the applicable country.

We may experience delays in initiating or completing clinical trials and preparing for regulatory submissions. We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could delay or prevent our ability to receive marketing approval or commercialize our current product candidate or any future product candidates. Our costs will increase if we experience delays in clinical testing or marketing approvals. We do not know whether any of our clinical trials will begin as planned, will need to be reassigned or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates and harming our business and results of operations. Any delays in our clinical development programs may harm our business, financial condition, and results of operations significantly.

We currently conduct and plan to conduct future clinical studies for our product candidates outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies.

We are conducting clinical studies that involve international centers. We could also in the future plan to conduct one or more future clinical studies of our product candidates outside the United States, including in Europe. The acceptance of study data from clinical studies conducted outside the United States or another jurisdiction by the FDA or comparable foreign regulatory authorities or notified bodies may be subject to certain conditions or may not be accepted at all.

In cases where data from clinical studies conducted outside the United States are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practice; (ii) the studies were performed by clinical investigators of recognized competence and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection

to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical study requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have similar approval requirements.

In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority or notified body will accept data from studies conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable regulatory authority or notified body does not accept such data, it would result in the need for additional studies, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

As an organization, we have never successfully completed any registrational clinical trials, and we may be unable to do so for any product candidates we may develop.

We will need to successfully complete registrational clinical trials in order to obtain the approval of the FDA or comparable foreign regulatory authorities to market our product candidate. Carrying out clinical trials, including later-stage registrational clinical trials, is a complicated process. As an organization, we have not previously completed any registrational clinical trials. In order to do so, we will need to build and expand our clinical development and regulatory capabilities, and we may be unable to recruit and train qualified personnel. We also expect to continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to submission and approval of PerQdisc. We may require more time and incur greater costs than expected. We may not succeed in obtaining regulatory approval of any product that we develop, or competitors may develop similar products that reach the market prior to PerQdisc, allowing them to claim market share and creating a barrier to entry for us. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing PerQdisc.

If we encounter difficulties enrolling patients in any of our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment or in patient follow-up activities in our clinical trials for a variety of reasons, including:

•        the patient eligibility and exclusion criteria defined in the protocol;

•        the size of the patient population required for analysis of the clinical trial’s primary endpoints;

•        the proximity of patients to clinical trial sites;

•        the design of the clinical trial;

•        our ability to recruit clinical trial investigators with the appropriate competencies and experience, and the ability of these investigators to identify and enroll suitable patients;

•        perception of the safety profile of our devices;

•        our ability to obtain and maintain patient consents; and

•        the risk that patients enrolled in clinical trials will drop out of the trials before completion.

In particular, some of our clinical trials will require patients that present specific characteristics in degenerative disc disease. Patients must have been unresponsive to conservative therapy, with no prior spine surgery. They must meet certain back pain and disability scores. The spine must be stable, uninjured, and not affected by tumors or infection.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our PerQdisc and any other product candidates that we may introduce in the future.

Our Breakthrough Device Designation from the FDA may not actually lead to a faster development or regulatory review or approval process, and we may be unable to obtain an investigational device exemption.

Our Breakthrough Device Designation is within the discretion of the FDA. While the FDA has granted that designation to PerQdisc, such designation may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures, and neither designation assures ultimate approval by the FDA. In addition, the FDA may later decide that the product no longer meets the qualification conditions and may rescind such designation.

We may not be able to convince physicians that our product is an attractive alternative to existing surgical and non-surgical treatments for low back pain.

Even if we are able to obtain regulatory approvals for PerQdisc, we will be unable to generate revenue unless we are also able to achieve and maintain market adoption and acceptance. In order to do that, we will need to make significant investments in educating surgeons, other medical professionals, and patients. Surgeons, in consultation with their patients, play the primary role in determining the course of treatment and, ultimately, any product that will be used in treatment. In order for us to sell our products successfully, we must demonstrate to surgeons, through education and training, that treatment with PerQdisc is beneficial, safe, and cost-effective for patients as compared to other surgical and non-surgical treatments and as compared to minimally invasive nucleus replacement products that other companies may develop. We will also need to educate surgeons on the proper placement technique for PerQdisc, as performance of our device is heavily dependent on implant positioning.

Because other companies that have attempted to develop nucleus replacement spinal stabilization devices have not been successful, we may face skepticism from spine surgeons and reluctance to use our surgical implementation system to treat moderate to severe discogenic low back pain. Surgeons also may be reluctant to learn the procedure for our surgical implant system because our approved indications will be more limited than what exists for other medical devices. For example, unlike candidates for spinal fusion surgery, patient candidates for nucleus replacement cannot present with other spinal injuries, tumors or infections. Additionally, there are other exclusion criteria that patient candidates for the PerQdisc cannot present with.

If we fail to effectively educate surgeons and other medical professionals about the clinical merits and patient benefits of PerQdisc, and the proper implantation procedure, they may not consider PerQdisc as a treatment option for its indicated conditions. As a result, the adoption of PerQdisc as a viable treatment option will be limited, which will adversely affect our revenues and profitability. Patient candidates for the PerQdisc also must have certain findings on standard Xrays and MRI imaging that are pre-defined in the clinical trial protocols. If they do not have certain findings, then they may not be candidates for the PerQdisc.

Surgeons may also hesitate to change their medical treatment practices for other reasons, including the following:

•        lack of experience with minimally invasive nucleus replacement procedures;

•        perceived liability risks generally associated with the use of new products and procedures;

•        costs associated with the purchase of new products; and

•        time commitment that may be required for training.

Furthermore, we believe surgeons will not widely use our products unless they determine, based on experience, clinical data, and published peer-reviewed publications, that surgical intervention provides benefits or is an attractive alternative to non-surgical treatments of moderate to severe discogenic low back pain. Until we have completed multiple studies with favorable results, some surgeons may be slow to adopt our products, third-party payors may be slow to provide coverage, and we may be subject to greater regulatory and product liability risks. In

addition, we believe support of our product relies heavily on long-term data showing its benefits. If we are unable to provide that data, surgeons may not use our products. In such circumstances, we may not achieve expected sales and may be unable to achieve profitability.

The acceptance of PerQdisc by other healthcare professionals, and patients, is also critical to our business success. Many patients with low back pain are cared for by pain physicians and other interventionalists, who are generally trained as anesthesiologists or physical medicine and rehabilitation specialists. These physicians often offer a variety of non-surgical and surgical interventions to patients moderate to severe discogenic low back pain, including, but not limited to, steroid injections, pain medication, physical therapy, radiofrequency ablation of the spinal nerves and other implant technologies. We will need to invest significant time and resources in professional education in order to teach these physicians, and other health care providers, about the benefits of PerQdisc, which we believe will prompt these providers to refer their patients with moderate to severe discogenic low back pain to surgeons who have been trained to perform PerQdisc’s minimally invasive surgical procedure.

These providers may, however, prefer to continue to treat these patients with the interventions they offer because they feel that these interventions are superior or because they have a financial interest in offering additional treatments to these patients. If we are unable to demonstrate to potential referring health care providers the comparative benefits of PerQdisc, and we are therefore unable to prompt sufficient numbers of these providers to refer their patients with moderate to severe discogenic low back pain for treatment by surgeons trained to implant PerQdisc, sales of PerQdisc could be limited, which would adversely affect our business, results of operations and financial condition.

Even if we are able to obtain regulatory approvals for our product candidate, our success will continue to depend on surgeons’ clinical experience with our PerQdisc Nucleus Replacement System. If our device does not result in positive outcomes for patients, or if clinical trials involving the use of our product candidate fail to show meaningful patient benefit, our business will be materially harmed.

Even if we are able to market the PerQdisc in the U.S. or other countries, surgeons initially will have no clinical experience with our device. Surgeons will not know if nucleus replacement surgery will result in patient benefit. If surgeons’ clinical experience with our implants in these procedures is not positive, or if our clinical trials do not show meaningful benefits to the patients undergoing this procedure, we will be unable to gain market acceptance for our product and our business will be materially harmed.

If hospitals, surgeons, and other healthcare providers are unable to obtain and maintain adequate or any coverage and reimbursement from third-party payors for procedures performed using our products, we may be unable to sell our product, and it is unlikely that it will gain market acceptance.

Even if we are able to obtain regulatory approval to market our product, our ability to gain market acceptance and sell our product will depend on the availability of adequate coverage and reimbursement from third-party payors, including, in the United States, government programs such as Medicare and Medicaid, private insurance plans, and managed care programs. Hospitals, surgeons, and other healthcare providers that purchase or use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated with the procedures performed with these devices. In order to qualify for reimbursement for a procedure using our PerQdisc Nucleus Replacement System, both the surgeon and the healthcare facility, either a hospital or ambulatory surgical center, will need to submit claims for reimbursement to the healthcare payor. We may be unable to sell our products on a profitable basis if third-party payors deny coverage, or if reimbursement levels are insufficient to support use of our products by healthcare facilities or to compensate surgeons for their time spent diagnosing patients and performing procedures using our products. Surgeons may be reluctant to put effort into learning and performing our nucleus replacement procedure, as well as to spend time to diagnose patients and obtain prior authorization from insurers, if third-party payors’ physician fee reimbursement levels are lower than what surgeons consider adequate.

Because nucleus replacement is a nascent treatment and no other similar spinal stabilization devices have been successfully commercialized to-date, third-party payors may treat the procedure as experimental or investigational, which would make it unlikely that they would regularly reimburse for the procedure or may increase the risk of claims being subject to frequent denials and/or appeals. Future action by the Centers for Medicare and Medicaid Services (“CMS”) or other third-party payors may further reduce the likelihood of payments to physicians, outpatient surgery centers, and/or hospitals for procedures using our products. For example, volatility in the payment rates that physicians and hospitals receive from CMS may have a material impact on their willingness to perform procedures including our products, as well as place additional pressure on pricing of our implants.

The healthcare industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs. Payors are imposing lower payment rates and negotiating reduced contract rates with service providers and being increasingly selective about the technologies and procedures they choose to cover. Payors may adopt policies in the future restricting access to medical technologies like ours and/or the procedures performed using such technologies. Therefore, we cannot be certain that our product or the procedures performed with our product will ever be approved for reimbursement, or approved at levels that will support market acceptance.

Market acceptance of our products in foreign markets may depend, in part, upon the availability of coverage and reimbursement within prevailing healthcare payment systems. Reimbursement and healthcare payment systems in international markets vary significantly by country and include both government-sponsored healthcare and private insurance. We may not obtain additional international coverage and reimbursement approvals in a timely manner, if at all. Our failure to receive such approvals would negatively impact market acceptance of our products in the international markets in which those approvals are sought.

The healthcare industry is experiencing fundamental changes that may make it more difficult for our product to qualify for reimbursement at levels that would support market acceptance.

Recent political, economic, and regulatory influences are subjecting the healthcare industry to fundamental changes that can impact coverage and reimbursement from third-party payors. We expect that the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2011, as currently enacted or as may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our existing products. CMS budget neutrality requirements may impose cuts to the Medicare physician fee schedule, which may be mitigated by acts of Congress or other changes to regulations. Other federal laws, known as budget sequestration, further reduce Medicare’s payments to providers. Under current legislation, the reduction in Medicare payments will vary from 2% under the Budget Control Act of 2011 (currently set to expire in 2031) to 4% if budget sequestration is triggered under the Statutory Pay-As-You-Go Act of 2010.

These reductions may reduce the level of reimbursement for which our product may eventually qualify, which could materially harm our business, and may also reduce providers’ revenues or profits, which could affect their ability to purchase new technologies. Both the federal and state governments in the U.S. and foreign governments continue to propose and pass new legislation and regulations designed to contain or reduce the cost of healthcare. Such legislation and regulations may result in decreased reimbursement for medical devices, which may further exacerbate industry-wide pressure to reduce the prices charged for medical devices. This could harm our ability to develop and market our products and generate sales, which would adversely affect our business, results of operations and financial condition.

If use of PerQdisc results in adverse events or serious adverse events, this may prevent our product from reaching or staying on the market, require safety warnings or otherwise limit sales.

Unforeseen adverse events and serious adverse events related to our products could arise either during clinical development or, if cleared, approved, or if CE certification has been obtained, after the product has been marketed. In clinical research, the most common adverse event related to our implant has been disruption of the implant, as a result of intraoperative damage to the cartilaginous endplates causing the implant to come into contact with the cortical bone. The surgical technique was updated to mitigate the risk of device disruptions. The most common adverse event related to the PerQdisc procedure was related to an increase in pain after surgery.

Additional adverse effects from our product candidate could arise either during clinical development or, if approved, cleared, or if CE certification has been obtained, after the product has been marketed. If we or others later identify adverse events caused by our product:

•        sales of the product, if any, may decrease significantly, and we may not achieve the anticipated market share;

•        regulatory authorities or our notified body may suspend, limit or withdraw approvals or certifications of such product, or seek an injunction against its manufacture or distribution;

•        regulatory authorities or our notified body may require changes to the labeling of our product. This may include the addition of labeling statements, specific warnings, and contraindications and issuing field alerts to physicians and patients;

•        we may be required to change instructions regarding the way the product is implanted or conduct additional clinical trials;

•        we may be subject to limitations on how we may promote the product;

•        regulatory authorities may require us to temporarily or permanently take our approved product off the market or to conduct other field safety corrective actions;

•        we may be subject to fines, injunctions or the imposition of criminal penalties;

•        we may be required to modify our product;

•        we may be subject to litigation fines or product liability claims; and

•        our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our products.

We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses.

Our business exposes us to potential product liability claims that are inherent in the testing, design, manufacture, and sale of surgical devices. Orthopedic spine surgeries involve significant risk of serious complications, including bleeding, nerve injury, paralysis, and even death. Surgeons or non-surgeon physicians may misuse or ineffectively use our products, which may result in unsatisfactory patient outcomes or patient injury. In addition, if longer-term patient results and experience indicate that our products or any component of a product cause tissue damage, motor impairment, or other adverse effects, we could be subject to significant liability. We could become the subject of product liability lawsuits alleging that component failures, manufacturing flaws, design defects, or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to patients. Product liability lawsuits and claims, safety alerts, or product recalls, regardless of their ultimate outcome, may have a material adverse effect on our business and our results of operations or financial condition, due to:

•        decreased demand for our product candidates or products that we may develop;

•        injury to our reputation;

•        withdrawal of clinical trial participants;

•        initiation of investigations by regulators;

•        costs to defend the related litigation;

•        a diversion of management’s time and our resources;

•        substantial monetary awards to trial participants or patients;

•        product recalls, withdrawals or labeling, marketing or promotional restrictions;

•        loss of revenue;

•        exhaustion of any available insurance and our capital resources;

•        the inability to commercialize any product candidate; and

•        a decline in our stock price.

Although we maintain third-party product liability insurance coverage, it is possible that claims against us may exceed the coverage limits of our insurance policies or cause us to record a self-insured loss. Even if any product liability loss is covered by an insurance policy, these policies typically have substantial retentions or deductibles that we are responsible for. Product liability claims in excess of applicable insurance coverage could have a material adverse effect on our business, results of operations, and financial condition.

In addition, any product liability claim brought against us, with or without merit, could result in an increase of our product liability insurance rates. Insurance coverage varies in cost and can be difficult to obtain, and we cannot guarantee that we will be able to obtain insurance coverage in the future on terms acceptable to us or at all.

We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if licensed, we may not be able to generate product revenue.

We currently have no sales, marketing or distribution capabilities and have no experience in marketing products. If we gain regulatory and marketing approval, we intend to develop an in-house marketing organization and direct sales force, which will require significant capital expenditures, management resources and time. We will have to compete with other medical device companies to recruit, hire, train and retain marketing and sales personnel.

If we gain regulatory and marketing approval, we also plan to market and sell our implants through third-party distributors. There can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidates entirely by ourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates.

There can be no assurance that we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas.

The Company’s ability to be successful following the Business Combination will depend upon the efforts of the Company Board and SST’s key personnel and the loss of such persons could negatively impact the operations and profitability of the Company’s business following the Business Combination.

The Company’s ability to be successful following the Business Combination will be dependent upon the efforts of the Company Board and key personnel. As of September 1, 2023, SST had approximately 10 employees in roles supporting, product development, clinical programs, regulatory, quality, manufacturing and general administrative and accounting, both domestically and internationally. We cannot assure you that, following the Business Combination, the Company Board and the Company’s key personnel will be effective or successful or remain with the Company. The loss of key personnel, or our inability to attract or retain other qualified personnel or advisors, could disrupt various business functions and have a material adverse effect on our business, results of operations, and financial condition. In particular, the loss of the services of our President and Chief Executive Officer, Mark Novotny, our Controller and General Manager of SST Spine Ltd., Brian Dowling, our Vice President of Research and Development, Loren Francis, or our Director of Regulatory and Quality, Molly Bond, could significantly delay or prevent the achievement of our strategic objectives.

Many of our employees have developed specialized skills which are valuable within the medical device and life sciences industry, and, in some cases, in a broader variety of industries. Competition for skilled employees is significant, and some of the labor markets we compete in have experienced tightening in the past year. If these conditions persist, we could experience turnover among our employees, or problems finding and recruiting new employees, which could become difficult and more costly to manage, adversely impacting our results of operation. Sustained pressure in these labor markets could also cause prevailing wages to rise, which could adversely impact our business, results of operation and financial condition.

Our employment agreements with our executive officers and other key personnel do not require them to continue to work for us for any specified period. We do not maintain “key person” insurance for any of our executives or employees. Although our U.S.-based employees, including executives, are generally subject to

24-month non-competition restrictions following termination of their employment, there is no guarantee that these agreements will be enforceable to the full extent of their terms or at all, particularly if pending rulemaking from the Federal Trade Commission is adopted to ban non-competition clauses. If we are unable to enforce these agreements, our executives or other key personnel could terminate their employment with us at any time and the adverse effect resulting from the loss of certain individuals could be compounded by our inability to prevent them from competing with us.

We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results will be adversely affected.

There is intense competition to commercialize an effective treatment for low back pain. Although we are not aware of any other approved nucleus replacement products in any market worldwide, other companies are researching this treatment option, including major medical device companies with more established reputations and longer histories of operations, and that have substantially greater financial, technical, and marketing resources than we do. These companies have greater resources to devote to research and development, and they may succeed in developing products that would render PerQdisc obsolete or noncompetitive. Many of these companies also have large sales forces which allow them to reach more surgeons.

We also compete with companies that offer spine fusion and total disc replacement products. Some of our current and potential competitors have wide product offerings for spine and orthopedic surgery, which allow them to bundle products in order to win large hospital group contracts and can create a barrier to entry for us. For example, some of our competitors offer fusion and or total disc replacement products which integrate with their surgical navigation and robotics platforms, enabling navigation of their procedures or performance of these procedures by surgical robots. If these competitors use technology, contracts, or intellectual property measures to limit or eliminate the compatibility of their surgical imaging, navigation and robotic systems with our products, sales of our product could be limited, which could adversely affect our business and results of operations.

We also expect there to be a continued push for non-surgical alternatives. Potential competitors are attempting to develop cell-based therapies for simple direct injection into a spinal disc or direct injection of biologic products or stem cells to try and rehabilitate the disc itself. Many of these potential competitors are early-stage smaller companies and target interventional pain and other physicians not trained as orthopedic and neurological surgeons for use of these products.

The existence of alternative treatments, and the introduction by competitors of products that are or claim to be superior to PerQdisc, may make it difficult to differentiate the benefits of our product over competing products and therapies. In addition, the entry of multiple new products and competitors may lead some of our competitors to employ pricing strategies that could adversely affect the pricing of our products and pricing in the market generally.

Our ability to compete successfully will depend on our ability to obtain regulatory approvals for PerQdisc in the U.S. and other countries, reach the market in a timely manner, receive adequate coverage and reimbursement from third-party payors, and be viewed as safer, less invasive, and more effective than alternatives available for similar purposes as demonstrated in peer-reviewed clinical publications. Because of the size of the potential market, other companies have dedicated, and likely will continue to dedicate, significant resources to developing competing products, and our competitive position will be subject to rapid change.

In the United States and Europe, we believe that our primary competitors marketing implantable devices currently are Medtronic, Johnson & Johnson, NuVasive, Stryker, and Globus, as well as a number of development-stage privately held companies. At any time, these or other industry participants may develop alternative treatments, products or procedures for the treatment of the low back pain that compete directly or indirectly with our PerQdisc Nucleus Replacement System. They may also develop and patent processes or products earlier than we can, or obtain domestic and international regulatory clearances or approvals and CE certification for competing products in the EU, more rapidly than we can, which could impair our ability to develop and commercialize similar processes or products. If alternative treatments are, or are perceived to be, superior to our products, we may be unable to successfully commercialize our product candidate, and our business will be materially harmed.

In the future our products may become obsolete, which would negatively affect operations and financial condition.

The medical device industry is characterized by rapid and significant change. Currently, PerQdisc is our sole product candidate, and we have not identified other potential product candidates outside of PerQdisc. There can be no assurance that other companies will not succeed in developing or marketing devices and products that are more effective than PerQdisc or that would render our PerQdisc surgical implant system obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our product.

As a result, without the timely introduction of new products and enhancements, our product may become obsolete over time. We might not be able to successfully develop, obtain domestic and international regulatory clearances or approvals, or CE certification for, or market new or modified products, and our future products, if any, might not be accepted by the surgeons or the third-party payors who reimburse for many of the procedures performed with our products. The success of any new product offering or enhancement to an existing product will depend on numerous factors, including those described elsewhere in this “Risk Factors” discussion. See “— Modifications to our products may require 510(k) clearances or premarket approvals and new conformity assessment by our notified body, or may require us to cease marketing or recall the modified products until clearances, approvals, or CE certification are obtained.”

If we do not develop and obtain domestic and international regulatory clearances or approvals and CE certification for new products or product enhancements in time to meet market demand, or if there is insufficient demand for these products or enhancements, our business could be adversely affected. Our research and development efforts may require a substantial investment of time and money before we are adequately able to determine the commercial viability of a new product, technology, material, or other innovation. In some cases, following a successful product development effort, we may need to invest substantial resources in surgical instrumentation and implant inventory, prior to launch of the product, and before we understand the demand for such product. If we overestimate the demand for such products and invest too heavily in inventory to support the product line, we may not achieve a positive return on such investments, which could cause our financial results to suffer. In addition, even if we are able to successfully develop enhancements or new generations of our products, these enhancements or new generations of products may not produce sales in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.

Pricing pressure from our competitors, changes in third-party coverage and reimbursement, healthcare provider consolidation, payor consolidation and the presence of “physician-owned distributorships” may impact our ability to eventually sell our product at prices necessary to support our current business strategies.

If competitive forces drive down the prices we expect to be able to charge for our product, the viability of our business strategy may be adversely affected and we may determine to abandon development of our product candidate or pursue alternative strategies. The low back pain market attracts numerous new companies and technologies. We believe there will be continuing increased pricing pressure.

Consolidation in the healthcare industry, including both third-party payors and healthcare providers, could lead to demands for price concessions or to the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business, results of operations, or financial condition.

Because healthcare costs have risen significantly over the past several years, numerous initiatives and reforms initiated by legislators, regulators, and third-party payors to curb these costs have resulted in a consolidation trend in the healthcare industry to aggregate purchasing power. As the healthcare industry consolidates, competition to provide products and services to industry participants has become and will continue to become more intense. This in turn has resulted and will likely continue to result in greater pricing pressures and the exclusion of certain suppliers from important market segments as group purchasing organizations, independent delivery networks, and large single accounts continue to use their market power to consolidate purchasing decisions for hospitals.

We expect that market demand, government regulation, third-party coverage, and reimbursement policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations and alliances among our customers, which may reduce competition, exert further downward pressure

on the prices of our products, and adversely impact our business, results of operations, or financial condition. We will face similar risks relating to adverse changes in coverage and reimbursement procedures and policies in Europe and other international markets.

Practice trends or other factors, including the COVID-19 pandemic, have caused, and may continue to cause, procedures to shift from the hospital environment to ambulatory surgical centers, or ASCs, where pressure on the prices of our products is generally more acute.

We anticipate that more outpatient eligible procedures will be performed in ASCs as a cost control measure within the healthcare system. This shift accelerated during the COVID-19 pandemic, and we expect it to continue because ASCs are generally a more economically favorable site of service, and surgeons performing the procedures sometimes have ownership interests in the ASC. Because ASC facility fee reimbursement is typically less than facility fee reimbursement for hospitals and due to surgeons’ economic interest in ASCs, we would expect to experience more pressure on the pricing of our products by ASCs than by hospitals, and we would expect the average price for which we sell our products to ASCs to be less than the average prices we would be able to charge to hospitals. In addition, some surgeons may choose to use fewer implants due to their interest in the profitability of the ASC. An accelerated shift of procedures using our products to ASCs could adversely impact the potential average selling price of our product and may affect our business strategy.

We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results.

Commercialization of PerQdisc in international markets is an element of our business strategy and involves risk. Operations in different countries, including the purchase of components and products from international sources, and the shipment of our products from the U.S. to Ireland for kitting, could expose us to additional and greater risks and potential costs, including:

•        fluctuations in currency exchange rates,

•        cross-border shipment delays that may affect our ability to deliver products to trial sites in a timely manner,

•        healthcare reform legislation,

•        the need to comply with different regulatory regimes worldwide that are subject to change and that could restrict our ability to manufacture and sell our products, including but not limited to challenging MDR requirements,

•        local product preferences and product requirements,

•        longer-term receivables than are typical in the U.S.,

•        economic sanctions, export controls, trade protection measures, tariffs and other border taxes, and import or export licensing requirements,

•        less intellectual property protection in some countries outside the U.S. than exists in the U.S.,

•        different labor regulations and workforce instability,

•        political and economic instability, including as a result of wars and insurrections,

•        the expiration and non-renewal of foreign tax rulings and/or grants,

•        potentially negative consequences from changes in or interpretations of tax laws, and

•        economic instability and inflation, recession or interest rate fluctuations.

The Russia-Ukraine conflict and resulting sanctions and export restrictions, as well as the changing relationship between the U.S. and China, are creating barriers to doing business in these countries and adversely impacting global supply chains. While we have no manufacturing, distribution or direct material suppliers in these regions, we continue to closely monitor the potential raw material/sub-tier supplier impact in Russia, Ukraine,

Belarus and China. China and Russia are significant contributors to the global supply of silicon, which is a key raw material for our product. Additional sanctions, export restrictions, and potential countermeasures within Russia may lead to greater uncertainty and geopolitical shifts in Asia that could cause additional adverse impacts on global supply chains and our business, results of operations, financial condition, and cash flows.

If our security measures, or those of our collaborators, contractors, consultants or other third parties upon whom we rely, are compromised or the security, confidentiality, integrity or availability of our information technology, software, services, networks, communications or data is compromised, limited or fails, we could experience a material adverse impact.

The efficient operation of our business depends on our information technology systems. In the ordinary course of our business, we may collect, process, receive, store, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively processing) proprietary, confidential and sensitive information, including personal data (including health information), clinical trial data, intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other parties. We rely on our information technology systems to effectively manage:

•        accounting and financial functions;

•        compliance and regulatory reporting requirements;

•        clinical trial databases;

•        our quality management system;

•        engineering and product development tasks; and

•        our research and development data.

Our information technology systems are vulnerable to damage or interruption from:

•        earthquakes, fires, floods, and other natural disasters;

•        terrorist attacks and attacks by computer viruses or hackers or internal or external breaches of our cybersecurity;

•        power losses; and

•        computer systems, internet, telecommunications, or data network failures.

The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our business operations, prevent or delay our clinical trials and regulatory approval processes, and prompt allegations of legal liability, all of which could have a material adverse effect on our reputation, business, results of operations, and financial condition. Our limited staffing and resources mean that we are able to devote less attention to our information technology environment than some larger companies, which affects our internal controls as well as our overall vulnerability to a breach.

Cybersecurity attacks, incidents, and interruptions are becoming increasingly prevalent and severe and can result in: the unauthorized publication of our confidential business or proprietary information; the unauthorized release of employee, customer or vendor data and payment information; significant interruptions, delays, or outages in our operations; disruptions to our clinical trials; loss of data (including data related to clinical trials); modification, destruction, loss, alteration, encryption, disclosure of, or access to other sensitive information; significant expense to restore data or systems; reputational loss; and the diversion of funds. In addition, the cost and operational consequences of implementing further data protection or data restoration measures could be significant.

We may also share or receive sensitive information from third parties, which presents risks. For example, supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach to our information technology systems or the third-party information technology systems that support us and our services. Our ability to monitor third parties’ information security practices is

limited, and these third parties may not have adequate information security measures in place. If a third party upon whom we rely experiences a security incident or is perceived to have experienced a security incident, we may also experience disruptions to our ability to manufacture or deliver our product candidate, or other adverse consequences.

We may expend significant resources, or modify our business activities and operations, including our clinical trial activities, in an effort to protect against security incidents. Certain data privacy and security obligations may require us to implement and maintain specific security measures or use industry-standard or reasonable security measures to protect our information technology systems and sensitive information.

We may experience phishing attacks on our email systems, other cyber-attacks, industrial espionage, insider threats, computer denial-of-service attacks, computer viruses, ransomware and other malware, wire fraud or other cyber incidents. Although we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. In addition, other entities that we work with, including our manufacturers, suppliers, clinical trial sites, and vendors, may experience incidents that would have an adverse impact on our business.

We may be unable to detect vulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities. Any failure to prevent or mitigate security incidents or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liability under state, federal, and international law and may cause a material adverse impact to our reputation, affect our ability to conduct our clinical trials and potentially disrupt our business.

Applicable data protection laws, privacy policies and data protection obligations may require us to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may also experience adverse consequences. These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other similar harms.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that the limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.

We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or adequately mitigate liabilities arising out of our privacy and security practices, or that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

Epidemic diseases, or the perception of their effects, may continue to adversely affect our business, financial condition, results of operations, or cash flows.

As the COVID-19 global pandemic enters its fourth year, the impact of COVID-19 on our business remains highly dependent on future developments, which are uncertain and unpredictable. Surgery for back pain is typically considered an elective procedure, which patients or healthcare providers may choose to delay in the event of any infectious disease outbreak. In addition, an outbreak of an infectious disease or an escalation of the COVID-19 pandemic, and governmental and societal responses to such events, could:

•        halt or suspend our clinical trials;

•        result in temporary closures of our facilities or the facilities of our suppliers and their contract manufacturers;

•        create delays or difficulties in enrolling and retaining patients in our clinical trials, including as a result of limitations imposed by federal, state or local governments or public concerns about contracting COVID-19 or any other infectious diseases;

•        interrupt key clinical trial activities, such as obtaining laboratory materials for collecting patient samples, clinical trial site data monitoring and efficacy, safety and translational data collection, processing and analyses, due to limitations on travel imposed or recommended by federal, state or local governments, employers and others or interruption of clinical trial subject visits, which may impact the collection and integrity of subject data and clinical study endpoints;

•        delay or disrupt the initiation or expansion of clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff;

•        increase adverse events and deaths in our clinical trials due to COVID-19 or other infections from an infectious disease;

•        increase rates of patients withdrawing from our clinical trials following enrollment as a result of contracting an infectious disease, such as COVID-19, or being forced to quarantine;

•        divert of healthcare resources away from the conduct of clinical trials or inability of clinical trial sites to hire and retain staff, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

•        delay or disrupt preclinical experiments and studies due to restrictions of on-site staff and unforeseen circumstances at contract research organizations and vendors;

•        interrupt or delay the operations of the FDA, the EMA, Notified Bodies, Competent Authorities, Ministries of Health, and comparable foreign regulatory agencies;

•        create interruptions or delays in receiving supplies of our raw materials or product candidates from our suppliers and CDMOs due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems, or due to prioritization of production for specific therapies or vaccines to address a public health crisis;

•        limit employee resources that would otherwise be focused on advancing our business, including because of sickness of employees or their families, including executive officers and other key employees, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions;

•        cause other disruptions to employee productivity, such as due to limited in person contact and reduction in employee morale; and

•        state and local government responses to a health epidemic or pandemic included and may in the future include “shelter in place,” “”stay at home” and similar types of orders, which have previously limited and may in the future limit travel and business operations in our locations, the location of our clinical trial sites, and the location of key vendors.

Any of these events could have a material adverse effect on our business.

In addition, the COVID-19 pandemic has adversely affected, and may continue to adversely affect, the economies and financial markets of many countries, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could curtail or delay spending by hospitals and affect demand for medical devices. These market disruptions could impair our ability to raise capital.

COVID-19 and the current financial, economic, and capital markets environment, and future developments in these and other areas present material uncertainty and risk with respect to our business, preclinical studies, clinical trials, performance, and financial condition. Due to the uncertain scope and duration of the pandemic and uncertain timing of global recovery and economic normalization, we are unable to estimate the long-term impacts on our operations and financial results.

The existence and further duration of the COVID-19 pandemic may also further exacerbate certain of the risks described herein.

We may encounter facility disruptions that would affect our ability to deliver packaged products to trial sites and customers, which could result in an adverse effect on our business and financial results.

We contract manufacture 100% of our products at a third-party facility in the U.S. The sub-assemblies are then shipped to our facility in Kilkenny, Ireland. We package 100% of our PerQdisc procedure kits at our Kilkenny facility, and from there we ship the kits to clinical trial sites or hospitals. Our Kilkenny facility is ISO-certified for the design, development, and manufacture of orthopedic implants. Accordingly, we are required to obtain and maintain various quality assurance and quality management certifications, including those issued by GMED, LNE our notified body. We are required to demonstrate continuing compliance with applicable regulatory requirements to maintain these certifications and will continue to be periodically inspected by international regulatory authorities for certification purposes. If the Kilkenny facility fails an ISO inspection, product development may still continue; however, a failed inspection may result in delivery delays to trial sites and customers, damage to our reputation, and could result in additional scrutiny of our CE certification by our notified body.

In addition to complying with regulatory requirements, we must assemble our products in adequate quantities and at an acceptable cost in order to commercialize PerQdisc and become profitable. Increasing our capacity to assemble, test and distribute our products will require us to improve internal efficiencies. We may encounter a number of difficulties in increasing our assembly and testing capacity, including:

•        maintaining quality control and assurance;

•        providing component and service availability;

•        maintaining adequate control policies and procedures;

•        hiring and retaining qualified personnel; and

•        responding appropriately to any facility shut-downs, which occur due to public health crises, labor shortages or disputes, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, closures from riots or public protests, and actions by businesses, communities and governments in response to any of the foregoing.

If we are unable to satisfy commercial demand for our products due to our inability to contract-manufacture, assemble and test, our ability to generate revenue would be impaired, market acceptance of our products could be adversely affected and customers may instead purchase or use our competitors’ products.

Risks Related to SST’s Reliance on Third Parties

Reduction or interruption in supply or other manufacturing difficulties may adversely affect our ability to conduct clinical trials and obtain regulatory approvals.

The manufacture of our PerQdisc Nucleus Replacement System requires the timely delivery of a sufficient amount of quality components and materials and is highly exacting and complex, due in part to strict regulatory requirements.

We, our contract manufacturer, and certain of our suppliers are required to comply with all applicable domestic and international regulations and current good manufacturing practices, which cover, among other things, the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of our products. If we or our any of the third parties that supply or manufacture our product or its components fail to adhere to current good manufacturing practice requirements, this could delay production of our product and lead to fines, difficulties in obtaining regulatory approvals, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could, in turn, have a material adverse effect on our financial condition or results of operations.

In addition, disruptions in the manufacturing, sterilization, or delivery process for any reason, including those that are outside of our direct control, could adversely affect our ability to complete our clinical trials, or complete them in a timely manner, and to receive regulatory approvals for our product. Mistakes and mishandling are not uncommon and can affect supply and delivery. Some of these risks include:

•        infrastructure, information and equipment malfunction;

•        failure to follow specific protocols and procedures;

•        failure to complete sterilization on time or in compliance with the required regulatory standards;

•        transportation and import and export risk;

•        delays in analytical results or failure of analytical techniques that we depend on for quality control and release of products;

•        defective raw materials, raw material availability, or other supply chain disruptions, including those caused by material and labor supply shortages in the wake of COVID-19; and

•        latent defects that may become apparent after products have been delivered for use in a clinical trial.

If any of these risks were to materialize, they could jeopardize the quality and safety of our products, which could prevent or delay our clinical trials, product development, and regulatory approval process.

We are dependent on a limited number of third-party suppliers, some of them single-source and some of them in single locations, for our products and components, and the loss of any of these suppliers, or their inability to deliver products in accordance with our specifications in a timely and cost-effective manner, could materially adversely affect our business.

We currently rely on a limited number of suppliers for silicone and other component materials. For us to be successful, our suppliers must be able to provide us with products and components in adequate quantities, in compliance with regulatory requirements, in accordance with agreed upon specifications, at acceptable prices, and on a timely basis.

All of the silicone materials of construction for the PerQdisc implant and imaging balloon membranes are sourced from a single supplier, and we currently are not aware of acceptable alternative suppliers. Although we maintain an inventory of raw materials that would allow us to continue manufacturing our product for several months if our supply was disrupted, any long-term disruption to our silicone parts supplier would significantly harm our business. Under our Master Supply Agreement, our supplier would be required to provide six months’ notice in order to terminate the agreement; however, that may not be sufficient time for us to find an acceptable alternative. We cannot guarantee that the Master Supply Agreement will be renewed on acceptable terms or at all, which means that our production may be halted or delayed upon its expiration, and we cannot guarantee that our supplier will continue to adequately perform under the terms of the agreement.

In addition, our Master Supply Agreement requires us to purchase 100% of our silicone requirements from this supplier, which further limits our ability to procure backup arrangements that would meet our needs.

We cannot assure investors that we will be able to obtain sufficient quantities of silicone or other components in the future. We may be unable to renew the agreements with our manufacturer and suppliers upon their respective expirations or terminations. Even if we are able to renew these agreements, we may be unable to do so with pricing and other terms that are favorable to us. Moreover, our dependence on such a limited number of suppliers exposes us to risks, including, among other things:

•        suppliers may fail to comply with regulatory requirements or make errors in manufacturing that could negatively affect the safety or effectiveness of our products or cause delays in product deliveries;

•        suppliers may fail to maintain good manufacturing practices, leading to quality control problems or regulatory findings that could cause disruptions in their manufacturing processes and lead to delays in deliveries of our products;

•        suppliers may be subject to price fluctuations due to a lack of long-term supply arrangements for key components;

•        suppliers may lose access to critical services, raw materials and components, or experience significant delays in obtaining them, resulting in an interruption in the manufacture and delivery of our products;

•        we may experience delays in delivery by our suppliers due to changes in demand from us or their other customers;

•        fluctuations in demand for products that our suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner;

•        our suppliers may wish to discontinue supplying components or services to us for risk management reasons;

•        we may not be able to find new or alternative components or reconfigure our processes in a timely manner if the necessary supplies or components become unavailable; and

•        our suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.

In addition, our suppliers may experience facility shut-downs, which occur due to public health crises, labor shortages or disputes, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, closures from riots or public protests, and actions by businesses, communities and governments in response to any of the foregoing. One of the facilities used by our single-source silicone supplier is located in a region in California prone to natural disasters, and we may experience a supply disruption if they are forced to relocate significant operations to alternative facilities on an unplanned basis.

If any one or more of these risks materialize, it could significantly increase our costs and impact our ability to complete our clinical trials and obtain regulatory approvals for our product candidate. If we are unable to complete our clinical trials in a timely manner, our ability to obtain regulatory approvals, commercialize our product and generate revenue will be impaired. Additionally, we could be forced to seek alternative sources of supply, which may be difficult.

In addition, most of our supply and manufacturing agreements do not have minimum manufacturing or purchase obligations. As such, with many of our suppliers, we have no obligation to buy any given quantity of products, and the suppliers have no obligation to sell us or to manufacture for us any given quantity of components or products. As a result, our ability to purchase adequate quantities of components or our products may be limited, and we may not be able to convince suppliers to make components and products available to us in some instances.

In addition, there is a risk that certain components could be discontinued and no longer available to us. We may be required to make significant “last time” purchases of component inventory that is being discontinued by the supplier to ensure supply continuity.

If we fail to obtain sufficient quantities of high-quality components to meet demand for our products in a timely manner or on terms acceptable to us, we would have to seek alternative sources of supply. Securing a replacement third-party manufacturer or supplier could be difficult. The introduction of new or alternative manufacturers or suppliers also may require design changes to our PerQdisc surgical implant system that would be subject to additional domestic and international regulatory clearances or approvals and the review of our notified body.

Because of the nature of our internal quality control requirements, regulatory requirements, and the custom and proprietary nature of the parts, we may not be able to quickly engage additional or replacement suppliers for many of our critical components. We may also be required to assess any potential new manufacturer’s compliance with all applicable regulations and guidelines, which could further impede our ability to manufacture our products in a timely manner. As a result, we could incur increased production and clinical trial costs, experience delays in the regulatory approval process, suffer damage to our reputation, and experience an adverse effect on our business and financial results.

We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA, our notified body and the competent authorities in the countries of the EU, or other foreign regulatory authorities, and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to delays in obtaining clearances or approvals, regulatory action including warning letters, product recalls, termination of distribution, product seizures, civil, administrative, or criminal penalties and the suspension, variation, or withdrawal of our CE certification. We could incur delays while we locate and engage qualified alternative suppliers, and we may be unable to engage alternative suppliers on favorable terms or at all. Any such disruption or increased expenses could harm our product development and commercialization efforts and adversely affect our ability to generate sales.

We currently rely and expect to rely in the future on the use of third-party manufacturing facilities or on third parties to manufacture our products. Our business could be adversely affected if we are unable to use third-party manufacturing facilities or if the third-party manufacturers encounter difficulties in production.

We contract manufacture 100% of our PerQdisc Nucleus Replacement Systems through Prospect Life Sciences (“PLS”) at a third-party facility in Colorado, pursuant to project-based statements of work that are governed by Master Terms & Conditions. Our current statements of work can be terminated upon 30 days’ notice by either party. In the event such agreements are terminated by either party upon 30 days’ notice, PLS will work with us to provide six months of our inventory requirements. We also rely on third-party manufacturers and manufacturing facilities for component parts, and procure important third-party services, such as sterilization services, at a facility located in California. Our current Master Terms & Conditions had an initial five-year term and were extended through August 23, 2026. We cannot guarantee that our service providers will perform to our specifications or will continue to perform under the terms of our existing contracts. If any third-party manufacturer with whom we contract fails to perform its obligations we will be forced to enter into an agreement with a different manufacturer. We cannot guarantee that we will be able to find alternative service providers in a timely manner and upon reasonable terms, or at all.

Our manufacturer operates at a facility in a single location, and substantially all of our inventory of component supplies and finished goods is held at that location prior to its shipment to our Kilkenny facility. A local public health crisis, vandalism, terrorism, or a natural or other disaster, such as a fire or flood, could damage or destroy equipment or our inventory of component supplies or finished products, cause substantial delays in our operations, result in the loss of key information, and cause us to incur additional expenses. Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our manufacturer’s facilities could harm our business, financial condition, and operating results.

We may not control the manufacturing process of, and may be completely dependent on, our contract manufacturing partners for compliance with regulatory requirements. Beyond periodic audits, we have no control over the ability of our CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our programs or if it withdraws any approval in the future, we may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs and materially adversely affect our ability to develop, obtain regulatory approval for or market our programs, if approved. Similarly, our failure, or the failure of our CMOs, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products and harm our business and results of operations.

Moreover, our dependence on such a limited number of manufacturers exposes us to risks, including, among other things:

•        our manufacturers may lose access to critical services, raw materials and components, or experience significant delays in obtaining them, resulting in an interruption in the manufacture and delivery of our products;

•        we may experience delays in delivery by our manufacturers due to changes in demand from us or their other customers;

•        fluctuations in demand for products that our manufacturers produce for others may affect their ability or willingness to deliver products to us in a timely manner;

•        our manufacturers may wish to discontinue supplying components or services to us for risk management reasons;

•        our manufacturers may experience facility shut-downs, which occur due to public health crises, labor shortages or disputes, natural disasters such as hurricanes, tornadoes, earthquakes, or wildfires, closures from riots or public protests, and actions by businesses, communities and governments in response to any of the foregoing;

•        we may not be able to find new or alternative manufacturers or reconfigure our processes in a timely manner if the necessary components or services become unavailable; and

•        our manufacturers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.

We and any of our CMOs may also face product seizure or detention or refusal to permit the import or export of products. Our business could be materially adversely affected by business disruptions to our third-party providers that could materially adversely affect our anticipated timelines, potential future revenue and financial condition and increase our costs and expenses. Each of these risks could delay or prevent the completion of our preclinical studies and clinical trials or the approval of our product candidate by the FDA, result in higher costs or adversely impact commercialization of our product candidate.

We have not yet caused our products to be manufactured on a commercial scale and may not be able to do so, if approved.

If any suppliers or manufacturers on which we will rely fail to supply or manufacture quantities of our products at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand at a cost that allows us to achieve profitability, our business, financial condition and prospects could be materially and adversely affected.

We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our programs.

We have utilized and plan to continue to utilize and depend upon independent investigators and collaborators, such as medical institutions, CROs, contract testing labs, specialized vendors, and strategic partners, to conduct and support our preclinical studies and clinical trials under agreements with us. We will rely heavily on these third parties over the course of our preclinical studies and clinical trials, and we control only certain aspects of their activities. As a result, we will have less direct control over the conduct, timing and completion of these preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff.

Nevertheless, we are responsible for ensuring that each of our studies and trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and our third-party contractors and CROs are required to comply with GCP regulations, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for all of our programs in clinical development. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting our clinical trials will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether they devote sufficient time and resources to our programs. These third parties may be involved in mergers, acquisitions or similar transactions and may have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could negatively affect their performance on our behalf and the timing thereof and could lead to products that compete directly or indirectly with our current or future programs. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our programs.

Disruptions at the FDA and other government agencies, both domestic and internationally, which may be caused by funding shortages, lack of qualified personnel, or global health concerns, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical personnel and stop critical activities. If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, supply agreements, or partnerships with third-parties that may not result in the generation of significant future revenue and may ultimately harm our competitive position.

In the ordinary course of our business, we may, in the future, enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, partnerships, supply agreements, or other arrangements to develop products and to pursue new markets and revenue streams. Proposing, negotiating, and implementing these arrangements may be a lengthy and complex process. Other companies, including those with substantially greater financial, marketing, sales, technology, or other business resources, may compete with us for these opportunities or arrangements, and some potential partners may be reluctant to enter into arrangements with us prior to our product receiving full regulatory approval.

We may not identify, secure, or complete any such transactions or arrangements in a timely manner, on a cost-effective basis, on acceptable terms or at all. We have limited institutional knowledge and experience with respect to these business development activities, and we may also not realize the anticipated benefits of any such transaction or arrangement. In particular, these collaborations may not result in significant revenue and could be terminated prior to experiencing any business benefit.

Disputes between us and our business parties may result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions and arrangements may not provide us with full intellectual property rights, or could impose various commercial or other obligations on us, which may adversely affect our competitive position.

Risks Related to Our Legal and Regulatory Environment

We, our suppliers, and our third-party manufacturers are subject to extensive governmental regulation both in the U.S. and abroad, and failure to comply with applicable requirements could cause our business to suffer.

The medical device industry is regulated extensively by governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies. The FDA and other U.S. and foreign governmental agencies regulate, among other things, with respect to medical devices:

•        design, development, and manufacturing;

•        testing, labeling, content, and language of instructions for use and storage;

•        clinical trials;

•        product safety;

•        marketing, sales, and distribution;

•        premarket clearance and approval;

•        conformity assessment procedures;

•        record keeping procedures;

•        advertising and promotion;

•        compliance with good manufacturing practices requirements;

•        recalls and field safety corrective actions;

•        post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury;

•        post-market approval studies; and

•        product import and export.

The regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, difficulties achieving new product clearances, higher than anticipated costs or lower than anticipated sales.

We must obtain FDA premarket approval in order to market and sell our product in the U.S., which is a complex, lengthy, and unpredictable process. If we are unable to obtain premarket approval, our business will be materially adversely affected.

Before we can market or sell a new regulated product in the U.S., with limited exceptions, we must obtain either clearance under Section 510(k) of the FDCA or approval of a PMA application from the FDA. The PerQdisc implant is regulated as a Class III device, which means that we must pursue the complex and expensive PMA application process. Moreover, because the PerQdisc will be considered a “first-of-a-kind” device, we believe our product will require review and recommendation by an FDA advisory panel, which is a particularly unpredictable and complex step in the PMA process.

The process of obtaining a PMA is costly, uncertain, and typically takes from one to three years, or even longer, from the time the application is submitted to the FDA until an approval is obtained. The process of obtaining domestic and international regulatory clearances or approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all.

The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:

•        we may not be able to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended uses;

•        the data from our preclinical studies and clinical trials may be insufficient to support clearance or approval, where required; or

•        the manufacturing process or facilities we use may not meet applicable requirements.

In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions which may prevent or delay clearance or approval of our products under development or impact our ability to modify our currently approved or cleared products on a timely basis. Any delay in, or failure to receive or maintain, clearance or approval for our products under development could prevent us from generating revenue from these products or achieving profitability.

Our devices must be approved under the medical devices legislation in the EU in order to be marketed in the EU. If we are unable to obtain and maintain a CE mark for our devices, our business will be materially adversely affected.

International jurisdictions require separate regulatory approvals and compliance with numerous and varying regulatory requirements. In the EU, a single regulatory approval process exists, and conformity with its requirements is required to affix a CE mark to our medical devices, without which they cannot be marketed or sold in the EU. To obtain a CE mark, devices must meet minimum standards of performance, safety, and quality, and then, according to their classification, undergo a conformity assessment procedure. Except for low-risk medical devices, a conformity assessment procedure requires the intervention of a third-party organization designated by the competent authorities of an EU country, known as a notified body. The competent authorities of the EU countries separately regulate the clinical research for medical devices and the market surveillance of products once they are placed on the market.

The PerQdisc was categorized as a class IIb device according to the MDD. Under the MDR (which has repealed and replaced the MDD), the PerQdisc device will be up classified as a class III medical device. MDR classification of medical devices is a risk-based system that takes into account the vulnerability of the human body and the potential risks associated with the medical device. The device classification system uses criteria such as duration of contact with the body, degree of invasiveness, local versus systemic effects, and potential toxicity. The MDR classification rules are established in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). The medical device classification dictates the regulations that are applicable to the device and outlines conformity assessment routes as well as clinical investigation requirements and post-market surveillance requirements.

Our PerQdisc CE certificate, which we obtained from our notified body, GMED, LNE, in May 2021, was suspended in September 2022 meaning we can no longer affix the CE mark to our PerQdisc device. We plan to continue to work with our notified body to remove the suspension of our CE certificate in the EU, but there is no guarantee that we will be successful or on what timing. In order to remove the suspension of our CE certificate, our notified body has confirmed that they require clinical evaluation data (including data with a statistically relevant number of subjects, a follow-up period and target patient population adapted to the device and the technique), which will present challenging patient consent and record-keeping requirements.

Even if our notified body agrees that our CE mark may be reinstated, as our original CE certificate was issued under the MDD (which has now been repealed and replaced by the MDR), our device must be re-assessed for conformity with the MDR before the expiration of the transition period in order for us to continue to be able to place our product on the market. The PerQdisc device is a class IIb implantable medical device under the MDD. Class IIb implantable medical devices lawfully placed on the market pursuant to the MDD prior to May 26, 2021 may generally continue to be made available on the market or put into service until, at the latest, 31 December 2027, provided certain requirements under the MDR are fulfilled (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies). This application process for certification under the MDR may require further clinical investigations and a new conformity assessment must be conducted by our notified body to confirm compliance with the MDR. Given the expanded scope of medical devices that require notified body review and approval under the MDR, we expect that our notified body will face resource limitations. Accordingly, our ability to re-file and obtain our CE mark under the MDR is a highly uncertain process and is likely to require substantial additional time and expense. See “— U.S. and European regulatory reforms may make it more difficult and costly for us to obtain regulatory clearances or approvals, and to manufacture, market, and distribute our products after approval is obtained.”

We will not be able to market or commercialize PerQdisc in the EU unless or until we achieve this clearance. There is no guarantee that we will be able to convince our notified body to remove the suspension for PerQdisc’s CE certificate.

We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.

The MDR and associated rules are generally applicable in the European Economic Area, which consists of the 27 EU Member States plus Norway, Liechtenstein and Iceland. In addition to the U.S. and the EU, we intend to continue to seek domestic and international regulatory clearance or approval to market our product in Great Britain (i.e., England, Wales and Scotland), Japan, China, and other key markets. The approval procedures vary among countries and may involve requirements for substantial additional testing, and the time required to obtain approval may differ from country to country.

For example, we must register our device with the Medicines and Healthcare Products Regulatory Agency (“MHRA”) before we are able to place them on the Great Britain Market. The MHRA will only register devices where the manufacturer or their United Kingdom Responsible Person has a registered place of business in the United Kingdom. Manufacturers based outside the United Kingdom will need to appoint a UK Responsible Person that has a registered place of business in the United Kingdom to register devices with the MHRA. In Great Britain, all medical devices also will require a UK Conformity Assessed (“UKCA”) mark. CE certificates issued by EU notified bodies will remain valid until, at the latest, June 30, 2030, but UKCA marks are not recognized in the EU. The rules for placing medical devices on the market in Northern Ireland, which is part of the United Kingdom, differ from those in the rest of the United Kingdom. We cannot guarantee that we will be able to comply with these regulations, which would prevent us from marketing or selling our products in Great Britain.

Clearance or approval by the FDA or obtaining a CE certification does not ensure approval or certification by regulatory authorities in other countries or jurisdictions, and approval or certification by one foreign regulatory authority does not ensure approval or certification by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval or certification process may include all of the risks associated with obtaining FDA clearance or approval, or a CE certification for a medical device in the EU, in addition to other risks. The time required to obtain foreign approval may differ from that required to obtain FDA clearance or approval, or a CE certification in the EU, and we may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals or certifications and may not receive necessary approvals to commercialize our products in any market. If we fail to receive necessary approvals or certifications to commercialize our products in foreign jurisdictions on a timely basis, or at all, our business, results of operations, and financial condition could be adversely affected.

U.S. and European regulatory reforms may make it more difficult and costly for us to obtain regulatory clearances or approvals, and to manufacture, market, and distribute our products after approval is obtained.

From time to time, Congress introduces legislation that could significantly change the statutory provisions governing the regulatory approval, manufacture, and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA, including as a result of leadership, personnel and structural changes within the FDA as well as federal election outcomes. Regulations and guidance may be revised or reinterpreted in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times for our product candidate, and could make it more difficult and costly to obtain clearance or approval. Significant delays in receiving clearance or approval, or the failure to receive clearance or approval for our product would jeopardize our ability to continue operations.

The MDR was published by the E.U. in 2017 and became effective on May 26, 2021. New medical devices marketed in the EU now require certification according to these new requirements, however devices with an existing certificate under the MDD must be certified under the MDR before the expiration of the applicable transition period. The PerQdisc device is a class IIb implantable medical device under the MDD. Class IIb implantable medical devices lawfully placed on the market pursuant to the MDD prior to May 26, 2021 may generally continue to be made available on the market or put into service until, at the latest, 31 December 2027, provided certain requirements under the MDR are met (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies). However, SST’s CE mark for PerQdisc as a class IIb device under the MDD was suspended and is unlikely to be reinstated. As a result, SST will likely need to re-file for a CE mark under the new MDR, pursuant to which the PerQdisc is a class III medical device.

The new EU MDR includes significant changes to the rules for placing medical devices on the market and requires extensive post-market surveillance. Changes include:

•        strengthening the rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market;

•        strengthening of the clinical data requirements related to medical devices;

•        strengthening of the designation and monitoring processes governing notified bodies;

•        creating the obligation for manufacturers and authorized representative to have a person responsible for regulatory compliance continuously at their disposal;

•        providing that authorized representatives are held legally responsible and liable for defective products placed on the EU market;

•        providing for increased traceability of medical devices following the introduction of a Unique Device Identification (“UDI”), system;

•        creating new rules governing the reprocessing of medical devices; and

•        creating increased transparency with the establishment of an EU database on medical devices (“EUDAMED”) containing information on economic operators, CE certificates, notified bodies, clinical investigations, UDI and device registration, adverse event reporting and market surveillance that would be available to the public.

The MDR also substantially impacts clinical investigations of medical devices. Among other things, it imposes specific obligations concerning incapacitated subjects, minors, pregnant or breastfeeding women and clinical investigations in emergency situations. In addition to detailed provisions concerning the authorization and conduct of clinical investigations, the MDR imposes on non-EU sponsors a responsibility to appoint a legal representative established in the EU and an obligation on EU Member States to ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place and places on sponsors and investigators the obligation to ensure they make use of these systems.

It will be challenging for us to comply with the MDR’s heightened compliance standards for PMCF. The PMCF process requires a full investigation protocol and collecting clinical data on a significant number of patients after a product is commercialized. The data collection process requires patient consent procedures that many hospitals are unable or unwilling to comply with, which restricts the number of available sites for conducting the clinical follow-up that the MDR requires. We expect these requirements to restrict the number of centers who are willing to purchase our product, which will harm our business.

The Company and the Notified Bodies who will oversee compliance to the new MDR face significant uncertainties as the MDR is rolled out and enforced by the applicable regulatory authorities in the upcoming years. Notified Bodies have lengthened their review times and may not have sufficient resources or expertise to implement the MDR, which could result in the issuance of CE marks under the MDR to be significantly delayed, canceled, or otherwise rejected. Penalties for regulatory non-compliance can be severe, including fines and revocation or suspension of a company’s business license, mandatory price reductions and criminal sanctions.

In addition, in Great Britain, all medical devices will require a UK Conformity Assessed (“UKCA”) mark. Compliance with the UK medical devices legislation is a prerequisite to be able to affix the UKCA mark to our products, when and if approved, without which they cannot be sold or marketed in Great Britain.

Even if our products are approved by regulatory authorities, if we, our contractors, or our suppliers fail to comply with ongoing FDA or other foreign regulatory requirements, or if we experience unanticipated problems with our current or future products, these products could be subject to restrictions or withdrawal from the market.

If we receive regulatory clearance or approval of PerQdisc or other future products, we will remain subject to ongoing and pervasive regulatory requirements governing, among other things, the manufacture, marketing, advertising, medical device reporting, post-approval clinical data, sale, promotion, import, export, registration, and listing of devices.

In addition, we will be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting to the FDA and the EU authorities of adverse events and malfunctions related to our products and submitting periodic reports to the FDA. If we fail to report these events to the FDA or applicable authority in another country within the required timeframes, the FDA or other applicable authorities could take enforcement action against us.

We and our suppliers and manufacturers also must continue to comply with FDA’s Quality System Regulations (“QSR”) and International Standards Organization (“ISO”) regulations for the manufacture of our products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage, and shipping of any product for which we obtain regulatory clearance or approval, or a CE certification.

The FDA and other regulatory authorities, including foreign authorities, have broad enforcement powers. The failure by us or one of our suppliers to comply with applicable statutes and regulations, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions:

•        untitled letters, warning letters, fines, injunctions, consent, and civil penalties;

•        unanticipated expenditures to address or defend such actions;

•        customer notifications for repair, replacement, refunds;

•        voluntary or mandatory recall, detention, or seizure of our products;

•        operating restrictions or partial suspension or total shutdown of production;

•        refusing or delaying our requests for 510(k) clearance or PMA and conformity assessments of new products or modified products;

•        changes to labeling and limitations on the intended uses for which the product may be marketed;

•        withdrawing 510(k) clearances or PMA approvals that have already been granted;

•        future additional suspensions, variations or withdrawals of CE certificates;

•        refusal to grant export approval for our products; and

•        criminal prosecution.

If product malfunctions do occur, we may be unable to correct the malfunctions adequately or prevent further malfunctions, in which case we may need to cease manufacture and distribution of the affected products, initiate voluntary recalls, and redesign the products. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

Regulatory enforcement or inquiries, or other increased scrutiny on us, could also adversely affect our reputation and the perceived safety and effectiveness of our products, which would dissuade some surgeons from using them. In addition, our response to adverse regulatory action could result in inability to produce our products in a cost-effective and timely manner or at all, decreased sales, higher prices, lower margins, additional unplanned costs or actions, damage to our reputation, and could have material adverse effect on our reputation, business, results of operations, and financial condition.

We may be subject to enforcement action, including fines, penalties or injunctions, if we are determined to be engaging in the off-label promotion of our products.

If we obtain approval for PerQdisc or any future product candidates, our promotional materials and training methods must comply with FDA and other applicable national and foreign laws and regulations, including the prohibition of the promotion of off-label use. Physicians may use our products off-label, as the FDA and equivalent third country authorities do not restrict or regulate a physician’s choice of treatment within the practice of medicine.

If the FDA or foreign or state regulator determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or promotional materials, require us to stop promoting our products for those specific procedures until we obtain FDA or third country authority clearance or approval for them, or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fines, and criminal penalties. Such an event could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false or fraudulent claims for payment of government fund.

In that event, our reputation could be damaged and adoption of the products would be impaired. In addition, the off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us and harm our reputation.

Modifications to our products may require 510(k) clearances or premarket approvals and new conformity assessment by our notified body, or may require us to cease marketing or recall the modified products until clearances, approvals, or CE certifications are obtained.

If we obtain regulatory approvals to market PerQdisc, we will continue to consider product improvements in order to remain competitive. Products that are approved through a PMA application generally need FDA approval before they can be modified. Similarly, for products initially cleared through a 510(k), any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in the intended use, design, or manufacture, requires a new 510(k) clearance or, possibly, a PMA. Both the 510(k) and PMA processes can be uncertain, expensive and lengthy and require the payment of significant fees, unless exempt.

The FDA requires every manufacturer to determine and document whether a proposed modification would require additional clearance or approval, which is dependent on whether the proposed modification could significantly affect safety or effectiveness of a previously approved product or represents a major change in its intended use. The FDA may review any manufacturer’s decision and may not agree with the manufacturer’s decisions regarding whether new clearances or approvals are necessary. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until such marketing authorization has been granted. The FDA may also on its own initiative determine that a new clearance or approval is required. If we market and sell a modified product without obtaining a new clearance or approval that the FDA deems to be required, we may be subject to significant enforcement actions, regulatory fines, or penalties, which could require us to redesign our products and harm our operating results.

Where we determine that modifications to our products require a 510(k) clearance or PMA, we may not be able to obtain those additional clearances or approvals for the modifications or additional indications in a timely manner, or at all. FDA’s ongoing review of the 510(k) program may make it more difficult for us to make modifications to our previously cleared products, either by imposing more strict requirements on when we must submit a new application for a modification to a previously cleared product, or by applying more onerous review criteria to such submissions.

In the EU, we must inform the notified body that carried out the conformity assessment of the medical devices we market or sell in the EU of any planned substantial changes to our quality system, manufacturing process, or changes to our devices which could affect compliance with the essential requirements or the devices’ intended use. The notified body will then assess the changes and verify whether they affect the products’ conformity with the general safety and performance requirements under the EU medical devices legislation. There can be no assurances that the assessment will be favorable and that the notified body will attest to our compliance with the applicable requirements, which will prevent us from selling our products in the EU. Moreover, any substantial changes that take place in the coming years may impact the continuing effectiveness of our CE certification that was issued on the basis of the MDD.

There is no guarantee that the FDA will grant 510(k) clearance or PMA of our future products or that our notified body will issue the required CE certificate, and failure to obtain necessary clearances or approvals for our future products would adversely affect our business prospects.

We and our sales representatives must comply with U.S. federal and state fraud and abuse laws, including those relating to healthcare provider kickbacks and false claims for reimbursement, and other applicable federal and state healthcare laws, as well as equivalent foreign laws, and failure to comply could negatively affect our business.

Healthcare providers, distributors and third-party payors play a primary role in the distribution, recommendation, ordering, and purchasing of any implant or other medical device for which we have or obtain marketing clearance or approval. If we obtain regulatory approval for PerQdisc and begin commercializing our surgical implant system, particularly if such activities occur in the United States, we expect that our arrangements with customers and third-party payors will expose us to the risk that our employees, independent contractors, principal investigators, consultants, vendors, or third-party distributors may engage in fraudulent or other illegal activity.

Misconduct by these parties could include, among other infractions or violations, intentional, reckless and/or negligent conduct or unauthorized activity that violates FDA regulations, manufacturing standards, federal and state healthcare fraud and abuse laws and regulations, laws that require the true, complete, and accurate reporting of financial

information or data, other commercial or regulatory laws or requirements, and equivalent foreign rules. It is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations, and government authorities may conclude that our business practices do not comply with applicable fraud and abuse or other healthcare laws and regulations or guidance despite our good faith efforts to comply.

There are numerous U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback, physician self-referral and false claims laws. Our relationships and our potential distributors’ relationships with surgeons, other healthcare professionals, and hospitals are subject to scrutiny under these laws. For example, we are subject to the federal health care Anti-Kickback Statute, the federal civil False Claims Act, the Health Insurance Portability and Accountability Act (“HIPAA”) and the U.S. Physician Payments Sunshine Act, each of which is described in detail in the sections entitled, “SST’s Business — Healthcare Fraud and Abuse” and “SST’s Business — Data Privacy and Security Laws.”

Certain states and countries also have enacted analogous state and foreign law equivalents of each of the above federal laws and may also mandate implementation of corporate compliance programs, require compliance with the industry’s voluntary compliance guidelines, impose restrictions on device manufacturer marketing practices, and/or require tracking and reporting of gifts, compensation, and other remuneration to healthcare professionals and entities. Many of these state and foreign laws differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

If we or our employees are found to have violated any of the above laws we may be subject to significant administrative, civil and criminal penalties, including imprisonment, exclusion from participation in federal healthcare programs, such as Medicare, Medicaid, and equivalent foreign programs, significant fines, monetary penalties and damages, imposition of compliance obligations and monitoring, the curtailment or restructuring of our operations, and damage to our reputation.

We have relationships with physicians and other professionals who may in the future become customers or refer patients and other professionals to our product. For example, certain SST equity owners are surgeons who have either purchased SST membership units or received units as consideration for services. At the Effective Time, the SST membership units held by these individuals will convert into Surviving Company Class A Membership Units and shares of Surviving Pubco Class V Common Stock in accordance with the Merger Agreement. In addition, we currently compensate three surgeons for consulting and advisory services that they provide to us, including Dr. Frank Phillips, who is expected to serve on the Board of Surviving Pubco following the Business Combination. Certain of these individuals also hold Class RB2 Units of SST, which are incentive awards intended to constitute profits interests. Their Class RB2 Units will vest in full and convert into Surviving Company Class A Membership Units and shares of Surviving Pubco Class V Common Stock upon consummation of the Business Combination, as provided in the Merger Agreement.

While we endeavor to comply with applicable exceptions and safe harbors under anti-kickback and other laws, certain of our current arrangements with physicians and other potential referral sources may not qualify for safe harbor protection. Failure to meet a safe harbor does not mean that the arrangement necessarily violates a statute, but it may subject the arrangements to greater scrutiny. We cannot offer assurances our practices will be found to comply with these regulations. Regulatory agencies may view these transactions as prohibited arrangements that must be restructured, or discontinued, or for which we could be subject to significant penalties and criminal, civil and administrative liability. We would be materially and adversely affected if regulatory agencies interpret our financial relationships with surgeons who order our products to be in violation of applicable laws and we were unable to comply with such laws.

Various state and federal regulatory and enforcement agencies continue actively to investigate violations of health care laws and regulations. To enforce compliance with the federal laws, the U.S. Department of Justice exercises continued scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. Dealing with a government investigation can be time- and resource-consuming and can divert management’s attention from the business. Additionally, if a healthcare company settles an investigation with the Department of Justice or other law enforcement agencies, it may need to agree to additional onerous compliance and reporting requirements as part of a consent decree, deferred or non-prosecution agreement, or corporate integrity agreement. Any such investigation