A regenerative medicine treatment for skin burns developed by Stratatech could make it to the market more quickly following a regulatory decision announced Tuesday.
The FDA has designated StrataGraft, a Stratatech-developed sheet of living tissue made from human cells that form into skin, as a Regenerative Medicine Advanced Therapy (RMAT), the company said. Drugs that treat rare diseases or life-threatening conditions can be placed on a faster regulatory pathway. RMAT creates that faster pathway for regenerative medicine products, including cell therapies and tissue-based products like StrataGraft. The designation allows companies to speak with the FDA earlier and more frequently during the regulatory process. RMAT doesn’t guarantee approval, but if all goes well, it could lead to a quicker FDA decision on the product.
Madison, WI-based Stratatech is a subsidiary of Mallinckrodt (NYSE: MNK). The U.K. pharmaceuticals giant acquired Stratatech a year ago for $76 million upfront, plus potential future milestone payments. Read the full story here.