Humacyte, Inc., a clinical-stage biotechnology platform company
developing universally implantable bioengineered human tissue at
commercial scale, announces the expansion of the strategic
collaboration between Fresenius Medical Care, the world’s largest
provider of dialysis products and services. Under the expanded
collaboration, Fresenius Medical Care will have the exclusive
rights to commercialize Humacyte’s 6 millimeter x 42 centimeter
human acellular vessel and all improvements thereto, and
modifications and derivatives thereof (HAVs) in vascular trauma
outside of the United States.
Under a Distribution Agreement entered into in June 2018,
Fresenius Medical Care obtained the exclusive global rights to
commercialize Humacyte’s HAVs in the applications of vascular
access for hemodialysis and peripheral arterial disease. Under the
expanded Distribution Agreement, Fresenius Medical Care and its
affiliates will have exclusive rights to develop outside the United
States and EU, and to commercialize outside of the United States,
Humacyte’s HAVs for use in the field of vascular creation, repair,
replacement or construction, including renal replacement therapy
for dialysis access, the treatment of peripheral arterial disease,
and the treatment of vascular trauma. The agreement excludes use of
the HAVs by Fresenius Medical Care for coronary artery bypass
grafting, pediatric heart surgery, or adhering pancreatic islet
cells onto the outer surface of the HAV for use in diabetic
patients. Within the United States, Fresenius Medical Care will
collaborate with Humacyte in its commercialization of HAVs in the
field described above, including adoption of HAVs as a standard of
care in patients for which such use is supported by clinical
results and health economic analyses.
“During our collaboration with Humacyte we have seen the
potential applications for their regenerative platform expand
significantly, and we look forward to partnering with Humacyte as
they continue their mission to bring an off the shelf and
universally implantable bioengineered human tissue to the care of
people in need of vascular surgery,” said Frank Maddux, MD, Chief
Medical Officer for Fresenius Medical Care. “This innovative
technology has the potential to provide improved outcomes for
patients and reduced medical and economic burdens to the healthcare
system.”
“We are pleased to expand our partnership with Fresenius Medical
Care, the world’s leading care provider for patients undergoing
kidney replacement therapy,” said Laura Niklason, M.D., Ph.D.,
Chief Executive Officer of Humacyte. “Our two teams have worked
well to prepare for the commercialization of our HAVs globally
since the formation of the partnership, and we look forward to
collaborating further to benefit patients, care providers and our
two companies.” Fresenius Medical Care has a network of more than
4,000 dialysis centers worldwide, and cares for over 300,000
patients with end-stage renal failure.
On February 17, 2021, Alpha Healthcare Acquisition Corp.
(Nasdaq: AHAC) (“AHAC”), a special purpose acquisition company, and
Humacyte announced the execution of a definitive business
combination agreement along with a fully committed $175 million
PIPE financing agreement. Fresenius Medical Care is the leading
participant in the PIPE financing.
About HumacyteHumacyte, Inc., is developing a
disruptive biotechnology platform to deliver universally
implantable bioengineered human tissues and organs designed to
improve the lives of patients and transform the practice of
medicine. The Company develops and manufactures acellular tissues
to treat a wide range of diseases, injuries and chronic conditions.
Humacyte’s initial opportunity, a portfolio of human acellular
vessels (HAVs), is currently in late-stage clinical trials
targeting multiple vascular applications, including vascular trauma
repair, arteriovenous access for hemodialysis, and peripheral
arterial disease. Pre-clinical development is also underway in
coronary artery bypass grafts, pediatric heart surgery, treatment
of type 1 diabetes, and multiple novel cell and tissue
applications. Humacyte’s HAVs were the first product to receive the
FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited
review designation and received priority designation for the
treatment of vascular trauma by the U.S. Secretary of Defense. For
more information, visit www.Humacyte.com.
About Alpha Healthcare Acquisition Corp.Alpha
Healthcare Acquisition Corp. (ticker: AHAC) is a special purpose
acquisition company formed for the purpose of effecting a business
combination with one or more businesses in the healthcare sector
(“AHAC”). The company was founded by Mr. Rajiv Shukla who has two
decades of buyouts, investments and operations experience in the
healthcare industry. Mr. Shukla previously served as Chairman
and Chief Executive Officer of Constellation Alpha Capital Corp., a
Nasdaq-listed special purpose acquisition company, that merged
with DermTech, Inc (ticker: DMTK) in August 2019. On February
17, 2021, AHAC announced a definitive agreement to merge with
Humacyte, Inc. along with a concurrent fully committed PIPE
placement of $175 million of AHAC common shares at a price of
$10.00 per share.
Important Information About the Merger and Where to Find
ItA full description of the terms of the business
combination is provided in a registration statement on Form S-4
filed with the SEC by AHAC that includes a prospectus with respect
to the Combined Company’s securities to be issued in connection
with the business combination and a proxy statement with respect to
the shareholder meeting of AHAC to vote on the business
combination. AHAC urges its investors, shareholders, and other
interested persons to read the preliminary proxy statement/
prospectus as well as other documents filed with the SEC because
these documents will contain important information about AHAC,
Humacyte and the business combination. After the registration
statement is declared effective, the definitive proxy
statement/prospectus included in the registration statement will be
mailed to shareholders of AHAC as of a record date to be
established for voting on the proposed business combination.
Shareholders will also be able to obtain a copy of the Form S-4,
including the proxy statement/prospectus, and other documents filed
with the SEC without charge, by directing a request to: Alpha
Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the
Americas, 5th Floor, New York, New York 10036. The
preliminary and definitive proxy statement/prospectus to be
included in the registration statement, can also be obtained,
without charge, at the SEC’s website (www.sec.gov).
Participants in the SolicitationAHAC and
Humacyte and their respective directors and executive officers may
be considered participants in the solicitation of proxies with
respect to the proposed business combination described in this
press release under the rules of the SEC. Information about the
directors and executive officers of AHAC is set forth in AHAC’s
final prospectus filed with the SEC pursuant to Rule 424(b) of the
Securities Act of 1933, as amended (the “Securities Act”) on
September 17, 2020, and is available free of charge at the SEC’s
website at www.sec.gov or by directing a request to: Alpha
Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the
Americas, 5th Floor, New York, New York 10036.
Information regarding the persons who may, under the rules of the
SEC, be deemed participants in the solicitation of the AHAC
shareholders in connection with the proposed business combination
will be set forth in the registration statement containing the
proxy statement/prospectus for the proposed business combination.
These documents can be obtained free of charge from the sources
indicated above.
Forward-Looking StatementsThis press release
contains forward-looking statements that are based on beliefs and
assumptions and on information currently available. In some cases,
you can identify forward-looking statements by the following words:
“may,” “will,” “could,” “would,” “should,” “expect,” “intend,”
“plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,”
“potential,” “continue,” “ongoing” or the negative of these terms
or other comparable terminology, although not all forward-looking
statements contain these words. These statements involve risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievements to be materially
different from the information expressed or implied by these
forward-looking statements. Although we believe that we have a
reasonable basis for each forward-looking statement contained in
this press release, we caution you that these statements are based
on a combination of facts and factors currently known by us and our
projections of the future, about which we cannot be certain.
Forward-looking statements in this press release include, but are
not limited to, statements regarding the initiation, timing,
progress, and results of our clinical trials; the anticipated
characteristics and performance of our HAVs, our ability to
successfully complete, pre-clinical and clinical trials for our
HAVs; the anticipated benefits of our HAVs relative to existing
alternatives; the commercialization of our HAVs and our ability to
manufacture at commercial scale; the implementation of our business
model, strategic plans for our business; our rights and obligations
under our partnership with Fresenius Medical Care; the scope of
protection we are able to establish and maintain for intellectual
property rights covering our HAVs and related technology; the
timing or likelihood of regulatory filings and approvals; timing,
scope, and rate of reimbursement for our HAVs; our estimated
available market opportunity; the proposed business combination,
including the timing and structure of the business combination, the
proceeds of the business combination, and the benefits of the
business combination. We cannot assure you that the forward-looking
statements in this press release will prove to be accurate. These
forward-looking statements are subject to a number of significant
risks and uncertainties that could cause actual results to differ
materially from expected results, including, among others, the
ability to complete the business combination due to the failure to
obtain approval from AHAC’s shareholders or satisfy other closing
conditions in the Business Combination Agreement, the occurrence of
any event that could give rise to the termination of the Business
Combination Agreement, the ability to recognize the anticipated
benefits of the business combination, the outcome of any legal
proceedings that may be instituted against AHAC or Humacyte
following announcement of the proposed business combination and
related transactions, the impact of COVID-19 on Humacyte’s business
and/or the ability of the parties to complete the business
combination, the ability to obtain or maintain the listing AHAC’s
common stock on Nasdaq following the proposed business combination,
costs related to the proposed business combination, changes in
applicable laws or regulations, the possibility that AHAC or
Humacyte may be adversely affected by other economic, business,
and/or competitive factors, and other risks and uncertainties,
including those included under the header “Risk Factors” in the
registration statement on Form S-4 filed by AHAC with the SEC and
those included under the header “Risk Factors” in the final
prospectus of AHAC related to its initial public offering. Most of
these factors are outside of AHAC’s and Humacyte’s control and are
difficult to predict. Furthermore, if the forward-looking
statements prove to be inaccurate, the inaccuracy may be material.
In light of the significant uncertainties in these forward-looking
statements, you should not regard these statements as a
representation or warranty by us or any other person that we will
achieve our objectives and plans in any specified time frame, or at
all. The forward-looking statements in this press release represent
our views as of the date of this press release. We anticipate that
subsequent events and developments will cause our views to change.
However, while we may elect to update these forward-looking
statements at some point in the future, we have no current
intention of doing so except to the extent required by applicable
law. You should, therefore, not rely on these forward-looking
statements as representing our views as of any date subsequent to
the date of this press release.
Non-SolicitationThis press release
is not a proxy statement or solicitation of a proxy, consent or
authorization with respect to any securities or in respect of the
proposed business combination and shall not constitute an offer to
sell or a solicitation of an offer to buy any securities nor shall
there be any sale of securities in any state or jurisdiction in
which such offer, solicitation, or sale would be unlawful prior to
registration or qualification under the securities laws of any such
state or jurisdiction. No offer of securities shall be made except
by means of a prospectus meeting the requirements of the Securities
Act.
Humacyte Investor
Contact:investors@humacyte.com
Humacyte Media Contact: media@humacyte.com
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