Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology
platform company developing universally implantable bioengineered
human tissue at commercial scale, today announced results from the
first series of compassionate use cases of Humacyte’s
investigational Human Acellular Vessel (HAV) for the treatment of
critical limb ischemia and vascular trauma. The HAVs were observed
to remain patent and infection free in patients requiring vascular
reconstruction, thereby highlighting the potential of the HAV to
expand limb salvage options for patients who have exhausted current
revascularization conduit options. These results were presented at
the 46th Annual Winter Meeting of the Vascular and Endovascular
Surgery Society (VESS).
Humacyte’s HAVs are engineered replacement vessels being
designed to be durable, infection-resistant and off-the-shelf to
address long-standing limitations in vessel tissue repair and
replacement. Under the U.S. Food and Drug Administration’s (FDA)
Expanded Access Program (EAP), the HAV has been implanted in more
than 20 patients to address multiple severe vascular repair,
reconstruction and replacement conditions when there is not a
suitable conduit available for treatment.
The results of eight of these EAP patients were reported at the
VESS meeting by Alexander Kersey, M.D., of the Uniformed Services
University of the Health Sciences and Walter Reed National Military
Medical Center in Bethesda, Md., in a presentation, titled, “Real
World Experience with the Human Acellular Vessel: A Bioengineered
Implant for Arterial Repair That Expands Limb Salvage Options.”
Each of the patients had severe peripheral arterial disease (PAD)
or vascular injury requiring vascular reconstruction but lacked
other treatment options and were at risk for limb loss. In this
high-risk group of patients, five of the bypasses performed with
the HAV currently remain patent (with follow-up times ranging from
four to 20 months after surgery), and no incidences of infection of
the HAV were noted. Researchers treating these patients concluded
that the HAV may greatly expand opportunities for limb salvage in
trauma and urgent vascular reconstruction when patients lack
suitable alternative conduits.
“Many patients who require urgent vascular reconstruction due to
vascular injury or severe peripheral arterial disease are not
candidates for synthetic vascular grafts or autologous vein grafts,
and those who’ve exhausted other treatment methods are at high risk
of amputation,” said Dr. Kersey. “There is considerable need for a
new treatment option to avoid resorting to amputation, and results
from these compassionate use cases merit additional research into
the role the HAV may play in the future of limb-sparing
surgery.”
In addition to infection resistance and durable patency, the
presentation highlighted the potential clinical utility of the HAV
that can be implanted using normal surgical procedures as a readily
available, biological alternative for patients at high risk for
amputation.
“Compassionate use cases are some of the most challenging cases,
often representing second or third-line interventions. We believe
the acellular, off-the-shelf availability and resistance to
infection highlight the potential for the HAV to be well suited to
these difficult revascularization scenarios caused by vascular
trauma and advanced PAD where other therapies are not available,”
said Laura Niklason, M.D., Ph.D., Founder, President and Chief
Executive Officer of Humacyte. “In these compassionate use cases,
the HAV performed reliably in the face of infected fields and
severe arterial disease, with no infections, and durably, with one
patient remaining patent for the duration of the reporting period
of 20 months. We believe these results underscore the potential of
the HAV to greatly expand opportunities for limb salvage in trauma
and urgent vascular reconstruction and we look forward to
continuing to follow these patients to fully assess the durability
of the HAV.”
The presentation is available on Humacyte.com.
The HAV is currently being evaluated in late-stage clinical
trials in vascular trauma repair, arteriovenous access for
hemodialysis, and PAD. The HAV is an investigational product
candidate and is not currently approved for sale by the FDA or any
international regulatory authority. For more information on
Humacyte’s EAP for HAV, visit
https://humacyte.com/expanded-access-policy/.
About HAVHuman Acellular Vessels (HAV) are
engineered off-the-shelf replacement vessels initially being
developed for vascular repair, reconstruction and replacement. HAV
is intended to overcome long-standing limitations in vessel tissue
repair and replacement – it can be manufactured at commercial
scale, it eliminates the need for harvesting a vessel from a
patient, and clinical evidence suggests that it is non-immunogenic,
infection-resistant, and can become durable living tissue. The HAV
is currently being evaluated in two Phase 3 trials in arteriovenous
access and a Phase 2/3 trial for vascular trauma, and has been used
in more than 460 patient implantations. It is the first product to
receive Regenerative Medicine Advanced Therapy (RMAT) designation
from the U.S. Food and Drug Administration (FDA), and has also
received FDA Fast Track designation.
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 preclinical and 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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