StrataTech gains FDA approval for ‘novel’ skin substitute to treat burns

By Erin Gretzinger, Wisconsin State Journal

Madison biotech company StrataTech received approval Tuesday from the U.S. Food and Drug Administration for StrataGraft, an innovative skin substitute designed to heal burn wounds, that will likely boost economic growth in Dane County.

StrataTech — owned by the U.K. pharmaceutical company Mallinckrodt — got the greenlight for StrataGraft from the FDA based on a promising phase three clinical study. Results showed 96% of patients did not need a donor tissue harvest to heal second-degree burn wounds, meaning most of the patient’s skin cells had been regenerated with their own cells thanks to a boost from StrataGraft.

A majority of patients’ wounds healed completely in the study, and there were no reports that the treatment was rejected.

“FDA approval of StrataGraft marks a significant milestone for the burn care community and underscores our unwavering commitment and ability to bring paradigm-changing treatment options to patients with severe and critical conditions,” said Steven Romano, Mallinckrodt’s executive vice president and chief scientific officer.

Over 20 years in the making, StrataGraft provides an alternative treatment option to conventional skin grafting, which frequently requires surgeons to remove parts of a patient’s own healthy skin and transplant it to the burn area to help it heal. Read more …