The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated.
“Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient return to the highest level of functionality and independence possible while improving the overall quality of life,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a news release. “This approval provides health care professionals a novel way to treat burn wounds.”
The gold standard treatment for many deep burns involves removing damaged, burned skin and replacing it with a skin graft. Skin grafts are often taken from the patient’s own body and moved to the burned area to heal it. However, the procedure leaves a new wound where the healthy skin was removed.
StrataGraft has two kinds of human skin cells called keratinocytes and dermal fibroblasts. The skin cells are grown together to make a bi-layered constructed called a cellularized scaffold.
The skin graft is made for topical application. It is placed onto a burn site by a healthcare provider and a patient’s skin cells will grow to replace the skin cells that were lost from the burn. Stratatech suggests that StrataGraft could help avoid or decrease the amount of healthy skin needed for a skin graft.
Stratatech received $86 million to develop the skin graft. The U.S. Biomedical Advanced Research and Development Authority awarded Mallinckrodt’s Stratatech $26 million in late 2018 under Project BioShield.