StrataGraft Skin Treatment Gets New FDA Regenerative Med Status

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expected to be completed by October 2018, and a Phase 3 trial that’s projected to finish in late 2019.

A spokeswoman for Mallickrodt said last month that the company anticipates an FDA decision on StrataGraft by 2020.

“RMAT designation of StrataGraft skin tissue speaks to the strength of the clinical data generated during the prior clinical study,” said Lynn-Allen Hoffmann, who founded Stratatech in 2000 and is now Mallinckrodt’s senior vice president of regenerative medicine. “Mallinckrodt is committed to developing advanced regenerative medicine therapies such as StrataGraft for patients with serious conditions.”

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