Stratatech has received a contract of up to $247 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
The contract is for the development of StrataGraft® skin tissue, the company’s skin replacement product, as a medical countermeasure to treat patients with severe thermal burns.
Clinical studies will enable Stratatech to file a BLA with the Food and Drug Administration for the commercial marketing of StrataGraft tissue, and confirm efficacy in all key patient populations.
The contract also provides for the procurement of finished product by the U.S. government to establish an inventory of StrataGraft tissue for use in case of a natural or man-made mass casualty emergency.
The five-year contract is structured with a base period plus defined contract options covering a series of clinical trials, product procurement, and other activities.
In July 2013, Stratatech won up to $47.2 million from BARDA for development of StrataGraft.The BARDA funds were also slated for scaling up 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,” the company said.