Picard Medical, Inc. (“Picard Medical”), the parent company of
SynCardia Systems, LLC (“SynCardia”), a global leader in mechanical
heart replacement technology, today announced that it has entered
into a definitive business combination agreement with Altitude
Acquisition Corp. (“Altitude”) (NASDAQ: ALTU), a publicly traded
special purpose acquisition company, that will result in Picard
Medical becoming a publicly listed company.
Upon closing of the transaction, Altitude will
be renamed Picard Medical Holdings, Inc. and is expected to remain
listed on Nasdaq.
SynCardia manufactures, sells, and markets the
world’s first and only FDA approved and commercially available
Total Artificial Heart (“TAH”) to replace the full functions of a
failing or failed human heart caused by end-stage, biventricular
heart failure. SynCardia’s products are approved for use in many
countries, including the United States and Canada. SynCardia is
working with regulatory authorities to have its CE mark reinstated
under EU MDR for most European Union countries. SynCardia has
successfully completed over 2,000 implants at over 140 hospitals,
prolonging the lives of patients facing terminal outcomes with few
alternative treatment options available.
Cardiovascular disease is the leading cause of
death globally and has resulted in 64.3 million heart failure
patients worldwide. SynCardia’s TAH has been designed to address
the growing and unmet needs of this patient population, which
represents a multi-billion-dollar market opportunity.
In the United States alone, there are
approximately 6.2 million cases of heart failure annually, leading
to over 380,000 deaths and $30.7 billion in medical costs. The only
definitive therapy for end-stage heart failure is heart
transplantation, and it is estimated that 300,000 patients
currently require this treatment option. Due to a limited supply of
donor hearts, little more than 3,000 (or approximately 1%) of these
patients will receive a heart transplant. There remains a
significant need for a reliable mechanical heart replacement
solution to address this shortfall and SynCardia’s TAH is the only
FDA approved option available to satisfy this growing and unmet
need in the United States.
Internationally, there remains a substantial and
growing market opportunity to provide end-stage heart failure
patients with wider access to TAH replacement therapy. SynCardia’s
TAH has produced strong clinical results, shown proven efficacy,
and is able to treat a broader range of patients in this population
compared to competing TAH products. SynCardia is expanding its
manufacturing capabilities, pursuing regulatory approvals, and
training new physicians across key growth regions, including China,
India, and the Middle East.
SynCardia projects substantial growth in 2023,
with sales expected to accelerate due to planned upgrades and new
products, enhanced sales and marketing activities, international
expansion, and pursuit of FDA approval of the Company’s existing
TAH to a long-term indication. SynCardia is expected to achieve
break-even profitability by 2024.
Management Comments
Gary Teplis, President & CEO of ALTU,
commented: “We couldn’t be more excited to partner with Picard
Medical in this transaction. SynCardia is a truly compelling
opportunity to address a global health crisis and improve the lives
of 64.3 million patients suffering from heart failure around the
globe. The problem is just too big to ignore. Throughout its
history, SynCardia has proven itself the leader in TAH technology
and we have every confidence in its ability to execute on its
growth plans, expand its addressable market and deliver positive
therapeutic outcomes to those who need it the most.”
Richard Fang, PhD, CEO of Picard Medical,
commented: “SynCardia has built a strong foundation as an industry
leader and is currently approaching a unique inflection point where
opportunities for growth are both clear and obtainable. Our
business combination with ALTU will provide the necessary
springboard to capitalize on these opportunities through
investments designed to increase accessibility of the SynCardia TAH
and continued development of next-generation technology. Our hope
is to prolong and improve the lives of the growing number of heart
failure patients throughout the world and we thank Gary and the
Altitude shareholders for their support.”
Transaction OverviewThe
proposed transaction values Picard Medical at an enterprise value
of $480 million, assuming no redemptions by Altitude Acquisition
Corp. shareholders, and calls for the combined company to have at
least $38 million in net cash at the time of closing. Existing
Picard Medical equity holders will roll 100% of their equity into
the combined public company.
Proceeds from the transaction are expected to
accelerate SynCardia’s international expansion, support its pursuit
of FDA approval for long-term indications, and advance research
& development of next generation products.
The transaction has been approved by the boards
of directors of both Altitude and Picard Medical. The transaction
is expected to close in the third or fourth quarter of 2023 and is
subject to the approval of the stockholders of Altitude and Picard
Medical, and other customary closing conditions. There can be no
assurance that the proposed transaction will be consummated on the
terms or timeframe currently contemplated, or at all.
AdvisorsWhite & Case LLP
acted as legal advisor to Altitude. Winston & Strawn LLP acted
as legal advisor to Picard Medical.
About Picard Medical,
Inc.Picard Medical is the parent company of SynCardia
Systems, a Tucson, Arizona based leader in mechanical heart
replacement technology for patients suffering from end-stage heart
failure. SynCardia develops, manufactures, and commercializes the
SynCardia Total Artificial Heart (TAH), an implantable system
designed to assume the full functions of a failing or failed human
heart. It is the first and only FDA approved TAH commercially
available in the United States and Canada. With 39 years of
clinical use, SynCardia’s TAH and its predecessors have been used
in over 2,000 implantations across 140 medical centers globally and
it is the most widely used and extensively studied TAH in the
world.
About Altitude Acquisition
Corp.Altitude Acquisition Corp. (Nasdaq: ALTUU, ALTU,
ALTUW) is a blank check company incorporated as a Delaware
corporation for the purpose of effecting a merger, capital stock
exchange, asset acquisition, stock purchase, reorganization or
similar business combination with one or more businesses or
entities.
Additional Information and Where to Find
ItIn connection to the proposed business combination,
Altitude intends to file with the U.S. Securities and Exchange
Commission’s (the “SEC”) a registration statement on Form S-4,
which will include a preliminary proxy statement/prospectus (a
“Proxy Statement/Prospectus”). A definitive Proxy
Statement/Prospectus will be mailed to Altitude’s stockholders as
of a record date to be established for voting on the proposed
transaction. Stockholders will also be able to obtain copies of the
Proxy Statement/Prospectus, without charge, at the SEC’s website at
www.sec.gov or by directing a request to: Altitude Acquisition
Corp., 400 Perimeter Center Terrace Suite 151, Atlanta, GA
30346.
This communication may be deemed to be offering
or solicitation material in respect of the proposed transaction,
which will be submitted to the stockholders of Altitude for their
consideration. Altitude urges investors, stockholders and other
interested persons to carefully read, when available, the
preliminary and definitive Proxy Statement/Prospectus as well as
other documents filed with the SEC (including any amendments or
supplements to the Proxy Statement/Prospectus, as applicable), in
each case, before making any investment or voting decision with
respect to the proposed transaction, because these documents will
contain important information about Altitude, Picard Medical and
the proposed transaction.
Participants in the
SolicitationAltitude and its directors and executive
officers may be considered participants in the solicitation of
proxies with respect to the proposed transaction described herein
under the rules of the SEC. Information about the directors and
executive officers of Altitude and a description of their interests
in Altitude and the proposed transaction are set forth in
Altitude’s Annual Report on Form 10-K for the year ended December
31, 2021, which was filed with the SEC on Mach 29, 2022 (as amended
on August 23, 2022, the “Annual Report”) and the Proxy
Statement/Prospectus, when it is filed with the SEC. These
documents can be obtained free of charge from the sources indicated
above.
No Offer or SolicitationThis
release shall not constitute a solicitation of a proxy, consent, or
authorization with respect to any securities or in respect of any
business combination. This release shall not constitute an offer to
sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any states or
jurisdictions in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering 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, or an exemption therefrom.
Forward-Looking
StatementsCertain statements made in this release are
“forward looking statements” within the meaning of the “safe
harbor” provisions of the United States Private Securities
Litigation Reform Act of 1995. When used in this release, the words
“estimates,” “projected,” “expects,” “anticipates,” “forecasts,”
“plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,”
“future,” “propose” and variations of these words or similar
expressions (or the negative versions of such words or expressions)
are intended to identify forward-looking statements. These
forward-looking statements are not guarantees of future
performance, conditions or results, and involve a number of known
and unknown risks, uncertainties, assumptions and other important
factors, many of which are outside Altitude’s control, that could
cause actual results or outcomes to differ materially from those
discussed in the forward-looking statements. Important factors,
among others, that may affect actual results or outcomes include:
the inability of Altitude to enter into a definitive agreement with
respect to an initial business combination with Picard Medical,
Inc. within the time provided in Altitude’s amended and restated
certificate of incorporation; performance of Picard Medical’s
business; the risk that the approval of the stockholders of
Altitude for the proposed transaction is not obtained; failure to
realize the anticipated benefits of the proposed transaction,
including as a result of a delay in consummating the proposed
transaction; the amount of redemption requests made by Altitude’s
stockholders and the amount of funds remaining in Altitude’s trust
account after satisfaction of such requests; Altitude’s and the
Picard Medical’s ability to satisfy the conditions to closing the
proposed transaction; and those factors discussed in the Annual
Report under the heading “Risk Factors,” and other documents of
Altitude filed, or to be filed, with the SEC. Altitude does not
undertake any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
ContactCody Slach or Matthew
HauschGatewayALTU@gatewayir.com949-574-3860
Altitude Acquisition (NASDAQ:ALTU)
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부터 10월(10) 2024 으로 11월(11) 2024
Altitude Acquisition (NASDAQ:ALTU)
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부터 11월(11) 2023 으로 11월(11) 2024