Stratatech Corporation and the Biomedical Advanced Research and Development Authority (BARDA) achieved major milestones this week with the announcement of U.S. Food and Drug Administration (FDA) approval for StrataGraft, a treatment for adults with thermal burns.
Stratagraft is specifically meant for burns containing intact dermal elements for which surgical intervention is needed. The product consists of allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen. It can deliver viable cells to support the body’s ability to heal and can be cryopreserved in the meantime.
The treatment is meant for use in operating room-like conditions and can be sutured, stapled, or secured with a tissue adhesive.
For Stratatech, approval marks a major turning point for the product, which Stratatech and BARDA began developing in 2015. For the medical world at large, it represents an advancement in treating deep, partial-thickness burns, giving burn surgeons access to a new biologic treatment and reducing the need for autografting. In a phase three clinical trial, 96 percent of areas treated by StrataGraft did not require autografting as a result.
BARDA has been with the product since early development. With its approval, the organization achieved its 61st approval, licensure, or clearance of such a public-private partnership supported countermeasure over the last 15 years.