Stratatech said it won a contract from the Biomedical Advanced Research and Development Authority worth up to $247 million to develop its StrataGraft skin tissue designed for patients with severe thermal burns.
The 5-year structured BARDA contract grants an initial $60 million for the “base period” and to procure the eventual-finished StrataGraft product to establish an inventory for use in “case of a natural or man-made mass casualty emergency,” the company said.
“The financial impact of this new award to Stratatech is unquestionably significant and will accelerate our transition into a fully integrated, operating company. But the real beneficiaries here are the severe burn patients who for the 1st time will have a therapeutic option available to them in lieu of painful skin transplantation. Providing these patients with an off-the-shelf regenerative skin tissue has the potential to transform severe burn care. Our partnership with BARDA has been and continues to be instrumental in advancing this orphan product through clinical development,” CEO B. Lynn Allen-Hoffmann said in prepared remarks.
The contract comes with defined contract options to cover clinical trials of the device, which Stratatech said would allow it to file a biologics license application with the FDA to commercialize the device and “confirm efficacy in all key patient populations.”
The new contract replaces and expands upon a previous $47 million BARDA contract that brought in $18 million so far for the company, which brings the potential funding from Barda up to approximately $265 million, Stratatech said.
Completing the contract would “position the company’s StrataGraft skin tissue for rapid deployment as a medical countermeasure,” the company said.