Stratatech Corporation Lands Contract Worth $47.2 Million for Advanced Development of StrataGraft® Skin Tissue for Thermal Burns
7/31/2013 8:14:34 AM
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Stratatech Awarded BARDA Contract Valued up to $47.2 Million for
Advanced Development of StrataGraft® Skin Tissue for Thermal Burns
MADISON, Wis., July 31, 2013 – Stratatech Corp., a leader in regenerative medicine,
announced today that it has been awarded a contract valued at up to $47.2 million by the U.S.
Department of Health and Human Service’s Biomedical Advanced Research and Development
Authority (BARDA). The contract is for the advanced clinical and manufacturing development of
StrataGraft® skin tissue, the Company’s flagship skin replacement product, as a medical
countermeasure to treat patients with severe thermal burns.
The five year contract contains a two year base period, with contract options that extend an
additional three years. The total award will support the preclinical, clinical, regulatory and
technology development activities needed to complete the FDA approval process for use of
StrataGraft skin tissue to treat thermal burn injury. In addition, the contract funds manufacturing
process development and scale-up so that the Company will be positioned for large scale
production volumes that will be needed in case of a mass casualty event as well as for general
commercial needs. To the Company’s knowledge, this is the first BARDA contract awarded to a
company in the State of Wisconsin.
“Securing a highly competitive BARDA contract provides important recognition as to the
innovative quality and potential therapeutic impact of our technology,” said B. Lynn Allen-
Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “Not only does this
contract provide comprehensive funding to advance our lead product and expand its
prospective label indication, but the manufacturing platform being developed will support our
entire product portfolio of skin substitutes. We thank BARDA for their support, and look forward
to working collaboratively with them to advance this technology.”
There is an urgent need for new treatment options for burns. The American Burn Association
estimates that 1.1 million people suffer burns annually in the United States. Approximately
45,000 patients require hospitalization. Severe burns and other major skin trauma are lifethreatening
injuries that require immediate surgical intervention. Frequently, this involves
temporary coverage of the wounds with cadaver skin or synthetic dressings to prevent infection
and dehydration because there are no full-thickness skin substitutes commercially available for
the treatment of burns. Permanent closure of the wound is generally accomplished through
split-thickness skin autografting after the wound bed is sufficiently stable that it will accept the
transplanted tissue. Although this regimen is the standard of care for severe burns, the limited
availability of and potential for pathogen transmission from cadaver skin, as well as the painful
donor site wounds created during autograft surgery coupled with scarring in many instances,
are serious drawbacks to this approach.
In the case of a mass casualty event, the Government Accountability Office reports that more
than 10,000 patients might require thermal burn care. The limited number of specialized burn centers and related medical infrastructure in the U.S. creates a public health need for therapies
that could be deployed quickly for use in these and other care sites. Successful completion of
this contract would position the Company’s StrataGraft skin substitute for rapid deployment as a
The Biomedical Advanced Research and Development Authority within the Office of the
Assistant Secretary for Preparedness and Response in the U.S. Department of Health and
Human Services, provides an integrated, systematic approach to the development and
procurement of critical products needed for public health emergencies. In collaboration with the
National Institutes of Health, Department of Homeland Security, and other federal agencies,
BARDA plays a key role in the government’s efforts to develop medical countermeasures
needed to prevent or mitigate potential health effects from exposure to chemical, biological,
radiological and nuclear (CBRN) agents and other terrorist threats. Support for StrataGraft
product development is being provided under a CBRN program to advance technologies and
products to treat thermal burns. Funding for BARDA’s medical countermeasure development
programs is authorized under the Pandemic and All Hazards Preparedness Act of 2006
(PAHPA) and reauthorized under the Pandemic and All Hazards Preparedness Reauthorization
Act of 2013 (PAHPRA). Additional medical countermeasure programs are funded by BARDA
under the Project BioShield Act of 2004.
About Stratatech Corp.
Stratatech Corp. is a privately-held regenerative medicine company focused on the
development and commercialization of cell-based, tissue-engineered skin substitute products
for therapeutic and research applications. These products are made using the company’s
proprietary NIKS® cells – a consistent and well-characterized source of human keratinocyte
progenitor cells that faithfully reproduces normal epidermal skin architecture and barrier
function. The company is using these progenitor cells to create a portfolio of therapeutic
products to treat severe burns, non-healing ulcers, and other complex skin defects. The
company’s flagship product, StrataGraft® tissue, is in human clinical testing for the treatment of
severe burns and other traumatic skin loss. The company’s second therapeutic product,
ExpressGraft™ anti-infective tissue, is on track to enter clinical testing to treat non-healing
diabetic foot ulcers.
For more information about Stratatech, its technology and product pipeline, please visit the
company’s website at www.StratatechCorp.com.
B. Lynn Allen-Hoffmann, Ph.D., Chief Executive and Chief Scientific Officer
Russell Smestad, President
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