Madison, WI-based Stratatech has won up to $47.2 million from the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to advance clinical manufacturing and development of its StrataGraft® skin tissue to treat patients with severe thermal burns.
The potentially five-year BARDA contract will support the preclinical, clinical, regulatory, and technology development activities Stratatech must complete in order to submit StrataGraft for FDA approval for this indication.
The BARDA funds are also slated to support Stratatech in scaling up its manufacturing processes to better position the firm “for large-scale production volumes that will be needed in case of a mass casualty event as well as for general commercial needs,” it said. According to the Government Accountability Office, more than 10,000 patients might require thermal burn care in the case of a mass casualty event, Stratatech noted.
“Securing a highly competitive BARDA contract provides important recognition as to the innovative quality and potential therapeutic impact of our technology,” Stratatech CEO and CSO B. Lynn Allen-Hoffmann, Ph.D., said in a statement. “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."