Mallinckrodt plc announced that the U.S. Food and Drug Administration (FDA) has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). This project was funded in part with $86 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for Stratatech Corporation, a Mallinckrodt company, to develop StrataGraft. The FDA approval is supported by data from the pivotal Phase 3 STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3%-37% total body surface area, which was conducted at U.S. burn centers.