FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Stratatech Receives Five-Year Contract to Develop Skin Replacement Product

Oct. 9, 2015
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Stratatech has received a five-year contract of up to $247 million from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority for the advanced development of StrataGraft skin tissue, a skin replacement product to treat patients with severe thermal burns.

The planned clinical studies will enable Stratatech to file a BLA with the FDA to market the product.

The contract also provides the U.S. government an option to purchase StrataGraft tissue for use in case of a mass casualty emergency. — Michael Cipriano