Mallinckrodt announces publication of results from Phase 1b trial of StrataGraft
Mallinckrodt announced publication of results of its Phase 1b clinical trial of StrataGraft, an investigational regenerative tissue, in Burns, the journal of the International Society for Burn Injuries, or ISBI. Study data showed that treatment with a single application of StrataGraft tissue resulted in wound closure by three months in 27 of 29 study participants. None of these 27 study participants required the harvest of donor skin (autograft) by 28 days after application. Additionally, the observed characteristics of the wounds treated with StrataGraft were comparable to those treated with autograft at 12 months after treatment. The safety and effectiveness of StrataGraft have not yet been established by the FDA.