Honor Recognizes Humacyte’s Progress in Accelerating the
Manufacturing Platform and Process for Producing Vascular Conduits for
Hemodialysis and Vascular Trauma
DURHAM, N.C.–(BUSINESS WIRE)–Humacyte, an innovator in biotechnology and regenerative medicine,
received the Medical Technology Enterprise Consortium (MTEC) Large
Project Prototype of the Year Award, in recognition of the development
of its human acellular vessel (HAV). The MTEC Prototype of the Year
program honors leading-edge companies for outstanding scientific and
technical progress in developing therapies that align with MTEC’s
mission to accelerate solutions that restore health for America’s
military and veterans.
The U.S. Department of Defense (DoD) and MTEC have highlighted a
critical need to harness the potential of regenerative medicine to treat
traumatic vascular injuries of war. Humacyte’s HAV, HUMACYL®,
is an investigational, off-the-shelf bioengineered blood vessel that is
being studied for use in the repair and reconstruction of vascular
injuries from violent civilian or military events, limiting blood loss
and restoring blood flow to extremities.
“This remarkable recognition is a result of breakthrough technology
developed by an enthusiastic and agile team pushing the boundaries of
innovation in vascular research and the regenerative medicine space,”
said Theodore Lithgow, PhD, Chief Commercial Officer of Humacyte and
Principle Investigator of the MTEC project. “We are honored that MTEC
recognizes the potential of our HAV being investigated in the clinic as
a potential solution for patients with life- or limb-threatening
vascular trauma. Restoring blood flow is a critical first step in
addressing any traumatic injury. We are grateful for the support from
MTEC and the US Military. Our team is investigating the potential of our
technology to positively impact the lives of injured civilians and the
courageous members of our military through care of vascular trauma.”
MTEC is a national biomedical technology consortium with members from
industry, academia and the nonprofit sector. The organization’s mission
is to assist the U.S. Army Medical Research and Materiel Command
(USAMRMC) by providing cutting-edge technologies to transition medical
solutions to industry that protect, treat, and optimize warfighters’
health and performance across the full spectrum of military operations.
“Medical pioneers like Humacyte help MTEC live our mission to bring
forward the most innovative and effective therapies that preserve life
and enhance the recovery of injured warfighters,” Lauren Palestrini,
PhD, Director of Research, MTEC. “Through programs like ours, the hope
is that the novel work of this great organization may one day serve a
noble cause.”
Humacyte is a medical research, discovery and development company with
clinical and pre-clinical stage investigational products having
potential therapeutic applications across illnesses such as end-stage
renal disease, repair or replacement of damaged arteries, coronary
artery bypass surgery, and vascular trauma. In October 2017, Humacyte announced
that the company received a Broad Agency Announcement (BAA) contract
award from the DoD to help support the addition of clinical sites for
Humacyte’s Phase
II vascular trauma trial in the US. In September 2017, the company
also received
an award from MTEC to help support the ongoing development and
future commercialization of Humacyte’s HAV.
Humacyte’s HAV is currently in a Phase
III pivotal trial in the U.S. and Europe as a conduit for
hemodialysis in patients with end-stage renal disease. The company plans
to seek regulatory approval in both regions upon completion of the
trial. The company is also conducting a U.S.
Phase II clinical trial of the HAV as a bypass graft in patients
with peripheral arterial disease (PAD). Humacyte is also continuing its
efforts in advancing the development of future pipeline products that
may improve treatment outcomes for patients suffering from both vascular
and non-vascular diseases.
About Humacyte:
Humacyte, Inc., a privately held company founded by Dr. Laura E.
Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and
development company with clinical and pre-clinical stage investigational
products. Humacyte is primarily focused on developing and
commercializing a proprietary novel technology based on human
tissue-based products for key applications in regenerative medicine and
vascular surgery. The company uses its innovative, proprietary platform
technology to engineer human, extracellular matrix-based tissues that
can be shaped into tubes or sheets, with properties similar to native
tissues. These are being developed for potential use in many specific
applications, with the goal to significantly improve treatment outcomes
for many patients, including those with vascular disease and those
requiring hemodialysis. The company’s proprietary technologies are
designed to create off-the-shelf products that, once approved, can be
utilized in any patient. The company web site is www.humacyte.com.
All statements, other than statements of historical fact, included in
this announcement are forward-looking statements. In some cases, you can
identify forward-looking statements by terminology such as “will”,
“anticipate”, “expect”, “believe”, “intend” and “should” or the negative
of these terms or other comparable terminology. These statements relate
to future events or Humacyte’s clinical development programs, reflect
management’s current beliefs and expectations and involve known and
unknown risks, uncertainties and other factors that may cause Humacyte’s
actual results, performance or achievements to be materially different.
Except as required by law, Humacyte assumes no obligation to update
these forward-looking statements.
About MTEC:
MTEC is a biomedical technology consortium collaborating with multiple
government agencies under a 10-year renewable Other Transaction
Agreement with the U.S. Army Medical Research and Materiel Command. To
find out more about MTEC, visit mtec-sc.org.
Contacts
Media:
Nirav Suchak
ICR, PR for Humacyte
646.277.1257
Nirav.Suchak@icrinc.com