Date: Feb. 2
StrataGraft, an investigational regenerative skin tissue therapy, is in development for the treatment of adult patients with deep partial-thickness thermal burns.
On Aug. 10, the FDA accepted the application for priority review, assigning a PDUFA goal date of Feb. 2.
Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns, according to Mallinckrodt. Autograft, the current standard of care, involves surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care.
StrataGraft skin tissue is engineered to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.