- Spinal Stabilization Applied sciences is a pioneer in creating minimally invasive surgical therapies for particular sorts of decrease again ache. It’s focusing on a promising market alternative inside the areas of Augmented Discectomy and Degenerative Disc Illness.
- In March 2021, the FDA granted the PerQdisc Nucleus Substitute System, the Firm’s main product candidate, designation as a Breakthrough System, doubtlessly permitting for a extra streamlined FDA assessment course of and decreased regulatory prices.
- Proposed transaction represents a pre-money fairness worth of $240 million for Spinal Stabilization Applied sciences.
- Present Spinal Stabilization Applied sciences shareholders will roll 100% of their present fairness holdings into fairness of the mixed firm.
SAN ANTONIO, July 24, 2023 (BUSINESS WIRE)– Spinal Stabilization Applied sciences (“SST” or the “Firm”), a medical machine firm, and BlueRiver Acquisition Corp. (“BlueRiver”) (NYSE AM: BLUA), a publicly traded particular function acquisition firm, have entered right into a definitive enterprise mixture settlement. Upon the closing of the proposed transaction between SST and BlueRiver, the mixed firm will function as Spinal Stabilization Applied sciences and be listed on an accepted inventory change.
Spinal Stabilization Applied sciences is a medical machine firm centered on creating after which commercializing a proprietary lumbar implant for nucleus pulposus alternative to alleviate sure sorts of decrease again ache. SST’s flagship product, the PerQdisc, is a lumbar intervertebral disc nucleus alternative. The PerQdisc is an investigational machine within the U.S. and has not been accepted by the FDA.
The PerQdisc, a silicone-based prosthesis shaped in-situ, is designed to emulate the pure operate of the native nucleus pulposus, offering a motion-preserving surgical resolution. SST’s pioneering work has positioned it to be on the forefront of the marketplace for Augmented Discectomy and Degenerative Disc Illness therapies.
Spinal Stabilization Applied sciences Funding Highlights
- FDA Designation as a “Breakthrough System” and Scientific Research: In March 2021, the FDA designated the PerQdisc Nucleus Substitute Systemas a Breakthrough System. The Firm has been rigorously learning the PerQdisc and the process for implanting the PerQdisc in rigorous medical research outdoors the US. The information is being revealed and offered at surgical spine conferences and is getting used to help regulatory filings globally. The Firm web site (www.sstspine.com) shall be up to date with the newest information on an ongoing foundation.
- Underserved Market: Information from thePerQdisc medical trial program suggests PerQdisc could also be a most well-liked surgical possibility for sufferers with delicate to reasonable disc degeneration and with extreme again ache who’ve failed conservative remedy and for sufferers with a disc herniation requiring a discectomy process. These sufferers are normally not candidates for spinal fusion. As such, PerQdisc is designed to supply a much less invasive therapy possibility in comparison with different surgical therapies.
- Vital Progress Alternatives: The Firm, with its PerQdisc product, will search to penetrate the Augmented Discectomy market, a $4.8 billion alternative, and the Degenerative Disc Illness market, a $4.6 billion alternative.(1)
- Robust Product Differentiation: PerQdisc is designed to offer a swift, minimally invasive different to conventional surgical choices like spinal fusion and complete disc alternative therapies. Not like these invasive and time-consuming choices, PerQdisc’s distinctive custom-fit implant process is designated to protect the affected person’s anatomy together with the bones, muscle tissues and different comfortable tissues across the disc. Solely a small portion of the central a part of the disc is eliminated. Then the PerQdisc is inserted within the middle of the disc the place it cures inside 10 minutes. There are not any screws or rods or fixation units positioned throughout the process. Typically the sufferers will be discharged a lot sooner than sufferers receiving a spinal fusion or a complete disc alternative.
- FDA and the Investigational System Exemption trial (the “IDE”): The U.S. pivotal trial, pursuant to an IDE is predicted to start in Q2 2024. The IDE is being designed with enter from international spinal surgeon key opinion leaders who’ve participated in quite a few IDEs and have led many firms by this necessary step within the technique of gaining premarket approval to commercialize the know-how in the USA.
Transaction Phrases
The mixed firm would have an estimated post-transaction enterprise worth of roughly $302 million, assuming a proposed future $40.0 million fairness increase (the “PIPE”) and assuming 100% redemptions by BlueRiver public shareholders. Proceeds from the transaction, if any, shall be used to execute on the Firm’s marketing strategy together with funding the FDA pivotal trial and business enlargement. The proposed PIPE is topic to market and different situations, and there will be no assurance as as to whether or when the PIPE fairness increase could also be accomplished, or as to the precise measurement or phrases of the PIPE when and if dedicated and consummated.
BlueRiver’s and SST’s respective boards of administrators have accepted the transaction, which is predicted to shut within the fourth quarter of 2023, or early 2024, topic to regulatory and shareholder approvals and the satisfaction of different closing situations, together with the completion of mutual due diligence and a dedicated PIPE or different mutually passable financing leading to web proceeds of a minimum of $10 million. SST shareholders will roll 100% of their current SST fairness holdings and are anticipated to personal equity-linked securities representing roughly 70% of mixed firm on a non-fully diluted foundation instantly following the closing of the proposed enterprise mixture, assuming 100% redemptions by BlueRiver’s public stockholders and a proposed future $40.0 million PIPE increase. Extra details about the proposed transaction, together with a replica of the enterprise mixture settlement and investor presentation, shall be supplied in a Present Report on Type 8-Ok to be filed by BlueRiver with the Securities and Trade Fee (“SEC”) and shall be out there at www.sec.gov. The mixed firm will file a registration assertion (which is able to include a proxy assertion of BlueRiver and prospectus) with the SEC in reference to the transaction.
(1) Supply: Nationwide Ambulatory Medical Care Survey, Life Science Intelligence, International Surgical Process Volumes Database, Clemson College Analysis Basis and Firm estimates. |
Advisors
Cohen & Firm Capital Markets, a division of J.V.B. Monetary Group, LLC (“Cohen”), acts as BlueRiver’s unique monetary advisor and lead capital markets advisor. Goodwin Procter LLP is performing as BlueRiver’s authorized counsel. Kreager Mitchell, PLLC is performing as SST’s authorized counsel.
About Spinal Stabilization Applied sciences
Established in 2010, Spinal Stabilization Applied sciences™ (SST), is a medical machine agency within the U.S., specializing in nucleus pulposus alternative. SST’s flagship investigational machine, the PerQdisc, is an modern lumbar intervertebral disc nucleus alternative designed to alleviate continual decrease again ache related to Degenerative Disc Illness. For extra info, please go to https://www.sstspine.com/.
About BlueRiver
BlueRiver Acquisition Corp. is a particular function acquisition firm (“SPAC”) domiciled within the Cayman Islands shaped for the aim of effecting a merger, share change, asset acquisition, share buy, reorganization or comparable enterprise mixture with a number of companies. For extra info, please go to http://blueriverspac.com/.
Ahead-Wanting Statements
This communication incorporates “forward-looking statements” inside the that means of the U.S. federal securities legal guidelines. Such statements embody statements regarding anticipated future occasions and expectations that aren’t historic details. All statements aside from statements of historic truth are statements that might be deemed forward-looking statements. Ahead-looking statements are usually recognized by phrases comparable to “imagine,” “count on,” “anticipate,” “intend,” “goal,” “estimate,” “proceed,” “positions,” “plan,” “predict,” “mission,” “forecast,” “steerage,” “objective,” “goal,” “prospects,” “doable” or “potential,” by future conditional verbs comparable to “assume,” “will,” “would,” “ought to,” “might” or “might,” or by variations of such phrases or by comparable expressions or the destructive thereof. Precise outcomes might differ materially from these expressed or implied by forward-looking statements primarily based on a lot of elements, together with, with out limitation: (1) dangers associated to the consummation of the proposed transaction, together with the dangers that (a) the proposed transaction is probably not consummated on the phrases of the definitive enterprise mixture settlement or inside the anticipated time interval, or in any respect, (b) BlueRiver might fail to acquire stockholder approval of the proposed enterprise mixture, (c) the events might fail to safe required regulatory approvals below relevant legal guidelines, and (d) different situations to the consummation of the proposed transaction below the enterprise mixture settlement is probably not happy, together with with out limitation, the completion to the events’ mutual satisfaction of customary due diligence and the completion of the PIPE fairness increase or different mutually passable financing; (2) the results that any termination of the enterprise mixture settlement might have on BlueRiver or Spinal Stabilization Applied sciences or their respective enterprise, together with the dangers that BlueRiver’s share worth might decline considerably if the proposed transaction shouldn’t be accomplished; (3) the results that the announcement or pendency of the proposed transaction might have on Spinal Stabilization Applied sciences’ and its enterprise, together with the dangers that in consequence (a) BlueRiver’s enterprise, working outcomes or inventory worth might undergo or (b) BlueRiver’s or Spinal Stabilization Applied sciences’ present plans and operations could also be disrupted; (4) the shortcoming to acknowledge the anticipated advantages of the proposed transaction; (5) sudden prices ensuing from the proposed transaction; (6) adjustments typically financial situations; (7) regulatory situations and developments; (8) adjustments in relevant legal guidelines or laws; (9) the character, value and final result of pending and future litigation and different authorized proceedings, together with any such proceedings associated to the proposed transaction and instituted in opposition to BlueRiver, Spinal Stabilization Applied sciences and others; and (10) different dangers and uncertainties indicated occasionally within the registration and proxy assertion referring to the proposed transaction, together with these below “Threat Elements” therein, and in BlueRiver’s filings with the SEC. Potential buyers, shareholders and different readers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date on which they’re made. Neither BlueRiver nor Spinal Stabilization Applied sciences assumes any obligation to publicly replace any forward-looking assertion after it’s made, whether or not on account of new info, future occasions or in any other case, besides as required by legislation.
Extra Data and The place to Discover It
In reference to the proposed transaction, Spinal Stabilization Applied sciences intends to file with the SEC a registration assertion on Type S-4, which is able to embody a preliminary proxy assertion/prospectus and different related paperwork, which shall be each the proxy assertion to be distributed to BlueRiver’s stockholders in reference to BlueRiver’s solicitation of proxies for the vote by BlueRiver’s stockholders with respect to the proposed enterprise mixture and different issues as could also be described within the Registration Assertion, in addition to the prospectus referring to the provide and sale of the securities of Spinal Stabilization Applied sciences to be issued in reference to the enterprise mixture. STOCKHOLDERS OF BLUERIVER ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN) AND OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT SPINAL STABILIZATION TECHNOLOGIES AND BLUERIVER WILL FILE WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Stockholders and buyers will be capable of acquire free copies of the proxy assertion/prospectus and different related supplies (after they develop into out there) and different paperwork filed by Spinal Stabilization Applied sciences and BlueRiver on the SEC’s web site at www.sec.gov. Copies of the proxy assertion/prospectus (after they develop into out there) and the filings that shall be integrated by reference therein may be obtained, with out cost, on BlueRiver’s web site at https://www.blueriverspac.com/ or by directing a request to: BlueRiver Acquisition Corp., 250 West Nottingham Drive, Suite 400 San Antonio, Texas 78209.
Members in Solicitation
Every of BlueRiver and Spinal Stabilization Applied sciences and their respective administrators, govt officers and sure workers, could also be deemed, below SEC guidelines, to be members within the solicitation of proxies in respect of the proposed transaction. Data concerning BlueRiver’s administrators and govt officers is on the market in BlueRiver’s closing prospectus dated January 28, 2021 referring to its preliminary public providing and in BlueRiver’s subsequent filings with the SEC. Different info concerning Spinal Stabilization Applied sciences and the opposite members within the proxy solicitation and an outline of their direct and oblique pursuits, by safety holdings or in any other case, shall be contained within the proxy assertion/prospectus and different related supplies to be filed with the SEC (after they develop into out there). These paperwork will be obtained freed from cost from the sources indicated above.
No Supply or Solicitation
This communication is for informational functions solely and never supposed to and doesn’t represent a suggestion to subscribe for, purchase or promote, the solicitation of a suggestion to subscribe for, purchase or promote or an invite to subscribe for, purchase or promote any securities or the solicitation of any vote or approval in any jurisdiction pursuant to or in reference to the proposed transaction or in any other case, nor shall there be any sale, issuance or switch of securities in any jurisdiction in contravention of relevant legislation. No provide of securities shall be made besides via a prospectus assembly the necessities of Part 10 of the Securities Act of 1933, as amended, and in any other case in accordance with relevant legislation.
Contacts
John Gregg
admin@blueriverspac.com
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