Humacyte Announces Presentation of First Eight Expanded Access Cases Using Human Acellular Vessel™ (HAV) for Treatment of Critical Limb Ischemia at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society
06 Gennaio 2022 - 1:30PM
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology
platform company developing universally implantable bioengineered
human tissue at commercial scale, today announced that results from
the first series of compassionate use cases of Humacyte’s Human
Acellular VesselTM (HAV) will be presented at the 46th Annual
Winter Meeting of the Vascular and Endovascular Surgery Society
(VESS) in Snowmass, Colo. at 7:56 a.m. MST on January 28, 2022. The
presentation will describe the outcomes of HAV implantation into
eight patients for the treatment of critical limb ischemia, under
the U.S. Food and Drug Administration’s (FDA) Expanded Access
Program (EAP). The presentation, titled “Real World Experience with
the Human Acellular Vessel: A Bioengineered Implant for Arterial
Repair That Expands Limb Salvage Options,” will be made by
Alexander Kersey, M.D., of the Uniformed Services University of the
Health Sciences and Walter Reed National Military Medical Center in
Bethesda, MD.
Humacyte’s HAVs are engineered off-the-shelf replacement vessels
that are currently being evaluated in late-stage clinical trials in
vascular trauma repair, arteriovenous access for hemodialysis, and
peripheral arterial disease (PAD). The HAV has been used in EAP
cases for patients with severe PAD and vascular injury for whom
there are limited treatment options. The VESS presentation will
highlight eight HAV implantations in patients with PAD or vascular
injury who had exhausted other treatment options and would have
otherwise faced amputation and limb loss.
“Vascular reconstruction remains a critical need for successful
limb salvage. Many patients have limited options for
revascularizing their severely ischemic limbs, and we are
developing the HAV to potentially offer an immediate option for
difficult revascularization scenarios,” said Laura Niklason, M.D.,
Ph.D., Founder, President and Chief Executive Officer of Humacyte.
“This will be the first time that results from our use of the HAV
for limb salvage have been reported, and we’re looking forward to
Dr. Kersey’s presentation at VESS.”
The Annual Meeting of the VESS brings together internationally
recognized, fellowship-trained vascular surgeons, and provides the
premiere forum to promote the field of vascular and endovascular
surgery through education, advocacy and leadership. For more
information, visit https://vesurgery.org/meetings/winter/.
About HumacyteHumacyte, Inc. (Nasdaq: HUMA) 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. Preclinical 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.
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, preclinical and clinical trials for our
HAVs; the anticipated benefits of our HAVs relative to existing
alternatives; the anticipated commercialization of our HAVs and our
ability to manufacture at commercial scale; the implementation of
our business model and 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;
and our estimated available market opportunity. 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 impact of COVID-19 on Humacyte’s
business, changes in applicable laws or regulations, the
possibility that 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-1, as amended,
filed by Humacyte with the SEC. Most of these factors are outside
of 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.
Humacyte Investor
Contact:investors@humacyte.com
Humacyte Media Contact: media@humacyte.com
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