Humacyte Earns Spot on CNBC Disruptor 50 List

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Humacyte,
an innovator in biotechnology and regenerative medicine, has been
recognized on this year’s CNBC
Disruptor 50 list. Now in its fourth year, the list is a compilation
of the most promising private companies that CNBC believes will
transform the economy with their revolutionary products and services.
Humacyte developed the world’s first investigational bioengineered blood
vessel, a potential future option for providing vascular access for
patients with End-Stage Renal Disease (ESRD) who require hemodialysis, a
process of removing waste from the blood of patients whose kidneys no
longer do so adequately on their own.
“Many years in the lab, and many brilliant minds have led Humacyte to
where it is today, and we are humbled to be recognized by CNBC as one of
the top private companies disrupting the healthcare industry,” said
Laura Niklason, M.D., Ph.D., founder of Humacyte and the Nicholas Greene
Professor of Anesthesiology and Professor of Biomedical Engineering at
Yale University. “Our hope is to improve the healthcare for the
thousands of patients who undergo hemodialysis treatment, and
potentially down the road, to use our technology for additional
applications such as Coronary Artery Bypass, bypass for Peripheral
Arterial Disease, and vascular trauma.”
Humacyte’s vessel, known as HUMACYL®, is an investigational product
being studied in patients requiring vascular access. HUMACYL is being
evaluated as a potential alternative to synthetic
polytetrafluoroethylene (PTFE) grafts in hemodialysis patients who are
not candidates for fistula placement. HUMACYL is being studied in part
for its potential to reduce the number of complications such as
infection and multiple surgical interventions to maintain a functioning
graft.
If the U.S. Food and Drug Administration (FDA) approves HUMACYL for
marketing after the clinical trials on this investigational product are
complete, this potentially game-changing technology may be able to
provide ‘off-the-shelf,’ or ready-to-use, human tissue products that can
be implanted in dialysis patients and that may lead to more positive,
long-term clinical outcomes. HUMACYL received Fast Track status from the
FDA in 2014.
“We are immensely proud to earn this distinction,” said Carrie S. Cox,
Chairman and Chief Executive Officer of Humacyte. “The past year has
been one of great successes for our company – from securing a $150
million Series B funding commitment, to commencing our Phase III
clinical trial – and we are honored to be listed among outstanding
previous and current honorees who are also working to transform the
quality of patient care.”
Last month, Humacyte announced the
commencement of a Phase III clinical trial for its investigational
vessel. In the trial, HUMACYL will be compared to ePTFE grafts, the
current standard of care for patients not suitable for fistula. The
HUMANITY trial will be conducted at approximately 35 sites in the U.S.,
Europe and Israel with 350 evaluable subjects, making it the largest
study of any bioengineered vascular tissue to date.
About Humacyte
Humacyte, Inc., a privately held company founded 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,
sheets, or particulate conformations, 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.