July 31, 2013
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 life-threatening 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 medical countermeasure.
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.