- Spinal Stabilization Technologies is a pioneer in developing
minimally invasive surgical treatments for specific types of lower
back pain. It is targeting a promising market opportunity within
the areas of Augmented Discectomy and Degenerative Disc
Disease.
- In March 2021, the FDA granted the PerQdisc Nucleus Replacement
System, the Company’s leading product candidate, designation as a
Breakthrough Device, potentially allowing for a more streamlined
FDA review process and reduced regulatory costs.
- Proposed transaction represents a pre-money equity value of
$240 million for Spinal Stabilization Technologies.
- Existing Spinal Stabilization Technologies shareholders will
roll 100% of their current equity holdings into equity of the
combined company.
Spinal Stabilization Technologies (“SST” or the “Company”), a
medical device company, and BlueRiver Acquisition Corp.
("BlueRiver") (NYSE AM: BLUA), a publicly traded special purpose
acquisition company, have entered into a definitive business
combination agreement. Upon the closing of the proposed transaction
between SST and BlueRiver, the combined company will operate as
Spinal Stabilization Technologies and be listed on an approved
stock exchange.
Spinal Stabilization Technologies is a medical device company
focused on developing and then commercializing a proprietary lumbar
implant for nucleus pulposus replacement to alleviate certain types
of lower back pain. SST's flagship product, the PerQdisc, is a
lumbar intervertebral disc nucleus replacement. The PerQdisc is an
investigational device in the U.S. and has not been approved by the
FDA.
The PerQdisc, a silicone-based prosthesis formed in-situ, is
designed to emulate the natural function of the native nucleus
pulposus, providing a motion-preserving surgical solution. SST's
pioneering work has positioned it to be at the forefront of the
market for Augmented Discectomy and Degenerative Disc Disease
treatments.
Spinal Stabilization Technologies Investment
Highlights
- FDA Designation as a "Breakthrough Device" and Clinical
Studies: In March 2021, the FDA designated the PerQdisc Nucleus
Replacement System as a Breakthrough Device. The Company has been
carefully studying the PerQdisc and the procedure for implanting
the PerQdisc in rigorous clinical studies outside the US. The data
is being published and presented at surgical spine conferences and
is being used to support regulatory filings globally. The Company
website (www.sstspine.com) will be updated with the latest data on
an ongoing basis.
- Underserved Market: Data from the PerQdisc clinical
trial program suggests PerQdisc may be a preferred surgical option
for patients with mild to moderate disc degeneration and with
severe back pain who have failed conservative therapy and for
patients with a disc herniation requiring a discectomy procedure.
These patients are usually not candidates for spinal fusion. As
such, PerQdisc is designed to offer a less invasive treatment
option compared to other surgical treatments.
- Significant Growth Opportunities: The Company, with its
PerQdisc product, will seek to penetrate the Augmented Discectomy
market, a $4.8 billion opportunity, and the Degenerative Disc
Disease market, a $4.6 billion opportunity.(1)
- Strong Product Differentiation: PerQdisc is designed to
provide a swift, minimally invasive alternative to traditional
surgical options like spinal fusion and total disc replacement
treatments. Unlike these invasive and time-consuming options,
PerQdisc's unique custom-fit implant procedure is designated to
preserve the patient’s anatomy including the bones, muscles and
other soft tissues around the disc. Only a small portion of the
central part of the disc is removed. Then the PerQdisc is inserted
in the center of the disc where it cures within 10 minutes. There
are no screws or rods or fixation devices placed during the
procedure. In most cases the patients can be discharged much
earlier than patients receiving a spinal fusion or a total disc
replacement.
- FDA and the Investigational Device Exemption trial (the
“IDE”): The U.S. pivotal trial, pursuant to an IDE is expected
to begin in Q2 2024. The IDE is being designed with input from
global spinal surgeon key opinion leaders who have participated in
numerous IDEs and have led many companies through this important
step in the process of gaining premarket approval to commercialize
the technology in the United States.
Transaction Terms
The combined company would have an estimated post-transaction
enterprise value of approximately $302 million, assuming a proposed
future $40.0 million equity raise (the “PIPE”) and assuming 100%
redemptions by BlueRiver public shareholders. Proceeds from the
transaction, if any, will be used to execute on the Company’s
business plan including funding the FDA pivotal trial and
commercial expansion. The proposed PIPE is subject to market and
other conditions, and there can be no assurance as to whether or
when the PIPE equity raise may be completed, or as to the actual
size or terms of the PIPE when and if committed and
consummated.
BlueRiver’s and SST’s respective boards of directors have
approved the transaction, which is expected to close in the fourth
quarter of 2023, or early 2024, subject to regulatory and
shareholder approvals and the satisfaction of other closing
conditions, including the completion of mutual due diligence and a
committed PIPE or other mutually satisfactory financing resulting
in net proceeds of at least $10 million. SST shareholders will roll
100% of their existing SST equity holdings and are expected to own
equity-linked securities representing approximately 70% of combined
company on a non-fully diluted basis immediately following the
closing of the proposed business combination, assuming 100%
redemptions by BlueRiver’s public stockholders and a proposed
future $40.0 million PIPE raise. Additional information about the
proposed transaction, including a copy of the business combination
agreement and investor presentation, will be provided in a Current
Report on Form 8-K to be filed by BlueRiver with the Securities and
Exchange Commission (“SEC”) and will be available at www.sec.gov.
The combined company will file a registration statement (which will
contain a proxy statement of BlueRiver and prospectus) with the SEC
in connection with the transaction.
(1) Source: National Ambulatory Medical
Care Survey, Life Science Intelligence, Global Surgical Procedure
Volumes Database, Clemson University Research Foundation and
Company estimates.
Advisors
Cohen & Company Capital Markets, a division of J.V.B.
Financial Group, LLC (“Cohen”), acts as BlueRiver’s exclusive
financial advisor and lead capital markets advisor. Goodwin Procter
LLP is acting as BlueRiver’s legal counsel. Kreager Mitchell, PLLC
is acting as SST’s legal counsel.
About Spinal Stabilization Technologies
Established in 2010, Spinal Stabilization Technologies™ (SST),
is a medical device firm in the U.S., specializing in nucleus
pulposus replacement. SST's flagship investigational device, the
PerQdisc, is an innovative lumbar intervertebral disc nucleus
replacement designed to alleviate chronic lower back pain
associated with Degenerative Disc Disease. For more information,
please visit https://www.sstspine.com/.
About BlueRiver
BlueRiver Acquisition Corp. is a special purpose acquisition
company (“SPAC”) domiciled in the Cayman Islands formed for the
purpose of effecting a merger, share exchange, asset acquisition,
share purchase, reorganization or similar business combination with
one or more businesses. For more information, please visit
http://blueriverspac.com/.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of the U.S. federal securities laws. Such statements
include statements concerning anticipated future events and
expectations that are not historical facts. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. Forward-looking statements are
typically identified by words such as “believe,” “expect,”
“anticipate,” “intend,” “target,” “estimate,” “continue,”
“positions,” “plan,” “predict,” “project,” “forecast,” “guidance,”
“goal,” “objective,” “prospects,” “possible” or “potential,” by
future conditional verbs such as “assume,” “will,” “would,”
“should,” “could” or “may,” or by variations of such words or by
similar expressions or the negative thereof. Actual results may
vary materially from those expressed or implied by forward-looking
statements based on a number of factors, including, without
limitation: (1) risks related to the consummation of the proposed
transaction, including the risks that (a) the proposed transaction
may not be consummated on the terms of the definitive business
combination agreement or within the anticipated time period, or at
all, (b) BlueRiver may fail to obtain stockholder approval of the
proposed business combination, (c) the parties may fail to secure
required regulatory approvals under applicable laws, and (d) other
conditions to the consummation of the proposed transaction under
the business combination agreement may not be satisfied, including
without limitation, the completion to the parties’ mutual
satisfaction of customary due diligence and the completion of the
PIPE equity raise or other mutually satisfactory financing; (2) the
effects that any termination of the business combination agreement
may have on BlueRiver or Spinal Stabilization Technologies or their
respective business, including the risks that BlueRiver’s share
price may decline significantly if the proposed transaction is not
completed; (3) the effects that the announcement or pendency of the
proposed transaction may have on Spinal Stabilization Technologies’
and its business, including the risks that as a result (a)
BlueRiver’s business, operating results or stock price may suffer
or (b) BlueRiver’s or Spinal Stabilization Technologies’ current
plans and operations may be disrupted; (4) the inability to
recognize the anticipated benefits of the proposed transaction; (5)
unexpected costs resulting from the proposed transaction; (6)
changes in general economic conditions; (7) regulatory conditions
and developments; (8) changes in applicable laws or regulations;
(9) the nature, cost and outcome of pending and future litigation
and other legal proceedings, including any such proceedings related
to the proposed transaction and instituted against BlueRiver,
Spinal Stabilization Technologies and others; and (10) other risks
and uncertainties indicated from time to time in the registration
and proxy statement relating to the proposed transaction, including
those under "Risk Factors" therein, and in BlueRiver’s filings with
the SEC. Potential investors, shareholders and other readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date on which they are made.
Neither BlueRiver nor Spinal Stabilization Technologies assumes any
obligation to publicly update any forward-looking statement after
it is made, whether as a result of new information, future events
or otherwise, except as required by law.
Additional Information and Where to Find It
In connection with the proposed transaction, Spinal
Stabilization Technologies intends to file with the SEC a
registration statement on Form S-4, which will include a
preliminary proxy statement/prospectus and other relevant
documents, which will be both the proxy statement to be distributed
to BlueRiver’s stockholders in connection with BlueRiver’s
solicitation of proxies for the vote by BlueRiver’s stockholders
with respect to the proposed business combination and other matters
as may be described in the Registration Statement, as well as the
prospectus relating to the offer and sale of the securities of
Spinal Stabilization Technologies to be issued in connection with
the business combination. 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 investors will be able to
obtain free copies of the proxy statement/prospectus and other
relevant materials (when they become available) and other documents
filed by Spinal Stabilization Technologies and BlueRiver at the
SEC’s website at www.sec.gov. Copies of the proxy
statement/prospectus (when they become available) and the filings
that will be incorporated by reference therein may also be
obtained, without charge, on BlueRiver’s website at
https://www.blueriverspac.com/ or by directing a request to:
BlueRiver Acquisition Corp., 250 West Nottingham Drive, Suite 400
San Antonio, Texas 78209.
Participants in Solicitation
Each of BlueRiver and Spinal Stabilization Technologies and
their respective directors, executive officers and certain
employees, may be deemed, under SEC rules, to be participants in
the solicitation of proxies in respect of the proposed transaction.
Information regarding BlueRiver’s directors and executive officers
is available in BlueRiver’s final prospectus dated January 28, 2021
relating to its initial public offering and in BlueRiver’s
subsequent filings with the SEC. Other information regarding Spinal
Stabilization Technologies and the other participants in the proxy
solicitation and a description of their direct and indirect
interests, by security holdings or otherwise, will be contained in
the proxy statement/prospectus and other relevant materials to be
filed with the SEC (when they become available). These documents
can be obtained free of charge from the sources indicated
above.
No Offer or Solicitation
This communication is for informational purposes only and not
intended to and does not constitute an offer to subscribe for, buy
or sell, the solicitation of an offer to subscribe for, buy or sell
or an invitation to subscribe for, buy or sell any securities or
the solicitation of any vote or approval in any jurisdiction
pursuant to or in connection with the proposed transaction or
otherwise, nor shall there be any sale, issuance or transfer of
securities in any jurisdiction in contravention of applicable law.
No offer of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended, and otherwise in accordance with
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230724347479/en/
John Gregg admin@blueriverspac.com
BlueRiver Acquisition (NYSE:BLUA)
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BlueRiver Acquisition (NYSE:BLUA)
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