Stratatech/Mallinckrodt initiates a rolling submission to the FDA of StrataGraft ,a regenerative skin tissue therapy, for the treatment of burns.

Mallinckrodt Plc has announced that Stratatech, a Mallinckrodt company, has initiated the rolling submission of a Biologics License Application (BLA) to the FDA seeking approval to market StrataGraft, a regenerative skin tissue therapy, for the treatment of adult patients with deep partial-thickness thermal burns. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

The StrataGraft skin tissue BLA is based on data from the pivotal Phase III STRATA2016 clinical trial, previously published as an abstract in the Journal Of Burn Care & Research and accepted for presentation at the American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in “Burns”.