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 preclinical study of the use of Humacyte’s small-diameter
(3.5mm) Human Acellular Vessel (HAV) in coronary artery bypass
grafting (CABG), which were presented at Advanced Therapies Week.
The HAV maintained patency and exhibited host-cell remodeling and
regeneration in a non-human primate model.
CABG, performed approximately 400,000 times each year in the
U.S., is a surgical procedure where a vascular graft is placed to
bypass occluded coronary arteries and restore blood flow to the
heart. Saphenous vein grafts are used in 80-90% of CABG procedures
but have shown a 30% failure rate at one year.
In the preclinical study, the 3.5mm HAVs were implanted into
primates following ligation of the native right coronary artery,
and the primates were studied for six months. The HAVs that have
been examined to date, one being explanted at six months,
remained patent and vascular host-cell repopulation was observed.
The preclinical surgeries were performed by Alan P. Kypson, M.D.,
cardiothoracic surgeon, University of North Carolina Rex Hospital,
and Adam Williams, M.D., cardiothoracic surgeon, Duke University,
in collaboration with Duke’s Division of Laboratory Animal
Resources and Department of Surgery.
“Coronary artery bypass grafting is one of the most common
surgical procedures in the U.S., but it currently requires
surgically harvesting a saphenous vein for grafting. The quality
and availability of the venous conduit is a critically important
factor in a successful CABG and the potential to eliminate vein
harvesting with a universally implantable, readily available
acellular vessel is exciting,” said Dr. Kypson, who presented the
results today. “Results observed in this preclinical study
indicated the small-diameter HAV was an effective replacement
vessel for CABG surgery in baboons, a primate that is
phylogenically similar to humans, which supports the continued
investigation of HAV in CABG.” Dr. Kypson has led the large animal
preclinical development of Humacyte’s vessels in CABG for more than
a decade.
Humacyte plans to evaluate the safety and efficacy of these
small-diameter HAVs in additional preclinical primate CABG studies
designed to support first-in-human clinical trials. The 3.5mm
diameter HAV has smaller product dimensions but is manufactured
using a similar process as Humacyte’s 6mm HAV system currently
being evaluated in advanced-stage clinical trials in vascular
trauma, arteriovenous access for hemodialysis, and peripheral
arterial disease. The production of the functional 3.5mm HAV is
indicative of the potentially broad application of Humacyte’s
proprietary bioengineered tissue platform and manufacturing
processes. Humacyte also presented preclinical data on the 3.5mm
HAV in pediatric heart disease at the American Heart Association’s
Scientific Sessions 2021. The HAV is an investigational product
candidate and is not currently approved for sale by the U.S. Food
and Drug Administration or any international regulatory
authority.
“We believe these results further underscore the promise of our
bioengineered tissue platform beyond our 6mm clinical-stage
vascular indications and moving towards cardiac surgical
procedures,” said Laura Niklason, M.D., Ph.D., Founder, President
and Chief Executive Officer of Humacyte. “We were pleased to see
the small-diameter HAV remained patent and to have observed
vascular host-cell repopulation comparable to clinical data
observed in multiple 6mm HAV clinical studies. We look forward to
continuing to evaluate the small-diameter HAV in CABG and
Blalock-Taussig-Thomas shunt, and to exploring the potential of our
off-the-shelf regenerative medicine technology in a range of
indications with critical unmet medical needs.”
The presentation will be available on Humacyte.com.
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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