BOSTON, June 11, 2018 /PRNewswire/ -- Fresenius Medical
Care, the world's largest provider of dialysis products and
services, and Humacyte, Inc., a medical research, discovery and
development company, today announced a strategic, global
partnership and a $150M USD equity
investment. This agreement has the potential to make Humacyte's
investigational human acellular vessel, HUMACYL®,
available to more patients worldwide following approval of the
product. HUMACYL is currently being investigated for vascular
access for hemodialysis and may prove more effective than current
synthetic grafts and fistula. Under the terms of the agreement,
Fresenius Medical Care will obtain the exclusive global rights to
commercialize HUMACYL.
Fresenius Medical Care will be responsible for the marketing,
sales and distribution of HUMACYL following approval by the
relevant health authorities. In addition, Fresenius Medical Care
will make a $150M USD equity
investment in Humacyte to gain a 19% fully diluted ownership stake
in the company. With the investment, Fresenius Medical Care will
have the opportunity to bring transformative clinical innovation in
the form of Humacyte's bioengineered human acellular vessels to the
worldwide end stage renal disease (ESRD) patient population
following product approval. The transaction is subject to customary
closing conditions, including expiration or termination of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended, and is expected to close in July 2018.
"By partnering with Humacyte, Fresenius Medical Care has an
opportunity to offer a dialysis vascular access option with the
potential for significant clinical efficacy and safety
improvements, including the potential to minimize catheter contact
time to the benefit of our patients," said Franklin Maddux, MD, Chief Medical Officer for
Fresenius Medical Care North America. "Our exclusive rights to
distribute this innovative technology to dialysis patients
worldwide may have significant benefits not only to patients, but
health systems as well. With the potential for fewer anticipated
complications and interventions compared to synthetic grafts, we
may see increased safety for patients and reduced medical and
economic burdens to the healthcare system."
The current vascular access modalities necessary to deliver
dialysis treatment include fistulas, grafts and central venous
catheters. All three options have limitations. Half of fistulas
fail and do not mature in patients, delaying vascular access for
dialysis treatment. In the meantime, many patients need a central
venous catheter, which significantly increases the risk of
infection. Humacyte has developed a novel human tissue-based
investigational product, HUMACYL, for patients with ESRD requiring
hemodialysis. Compared to an arteriovenous fistula, HUMACYL can be
available for use in hemodialysis within weeks and may have an
overall higher rate of maturation. It also may offer a more
durable, biologic alternative to synthetic grafts.
"This is a transformational milestone for Humacyte, giving us
the world's strongest partner to help bring our product to more
patients globally," said Carrie Cox,
CEO and Chairman of Humacyte, Inc. "Our partnership will allow
Humacyte to focus on advancing the potential for HUMACYL as a
substantial breakthrough in the science of regenerative medicine,
and to continue our development of an exciting future
pipeline."
Humacyte's bioengineered blood vessel is currently in Phase III
pivotal trials in the U.S. and Europe, and the company plans to seek
regulatory approval in both regions upon completion of the
trials.
About Fresenius Medical Care
Fresenius Medical Care
is the world's largest provider of products and services for
individuals with renal diseases of which around 3.2 million
patients worldwide regularly undergo dialysis treatment. Through
its network of 3,790 dialysis clinics, Fresenius Medical Care
provides dialysis treatments for 322,253 patients around the globe.
Fresenius Medical Care is also the leading provider of dialysis
products such as dialysis machines or dialyzers. Along with its
core business, the company provides related medical services in the
field of Care Coordination. Fresenius Medical Care is listed on the
Frankfurt Stock Exchange (FME) and on the New York Stock Exchange
(FMS).
For more information visit the company's website at
www.freseniusmedicalcare.com.
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, 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 website is www.humacyte.com.
Disclaimer
This release contains forward-looking statements that are subject
to various risks and uncertainties. Actual results could differ
materially from those described in these forward-looking statements
due to certain factors, including changes in business, economic and
competitive conditions, risks and uncertainties in research and
development and the regulatory approval process; failure to satisfy
the conditions to the consummation of the transaction, including
the receipt of regulatory approval; regulatory reforms, foreign
exchange rate fluctuations, uncertainties in litigation or
investigative proceedings, and the availability of financing.
[Certain of these][These] and other risks and uncertainties are
detailed in Fresenius Medical Care AG & Co. KGaA's reports
filed with the U.S. Securities and Exchange Commission. Without
prejudice to its obligations under capital market laws, neither
Fresenius Medical Care AG & Co. KGaA nor Humacyte, Inc.
undertakes any responsibility to update the forward-looking
statements in this release.
Media Contact
Fresenius Medical Care
Matthias Link
T +49 6172 609-2872
matthias.link@fresenius.com
Fresenius Medical Care North America
Katherine Dobbs
T +1 781-699-9039
katherine.dobbs@fmc-na.com
Contact for Analysts and Investors
Dr. Dominik Heger
T +49 6172 609-2601
dominik.heger@fmc-ag.com
www.freseniusmedicalcare.com
Humacyte, Inc. Media Contact
Matthew Lindberg
ICR
T +1 203-682-8214
matthew.lindberg@icrinc.com
www.humacyte.com
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SOURCE Fresenius Medical Care Holdings, Inc.