Advanced Tissue submits PMA

ATIS and partner Smith & Nephew (SNN) submitted a PMA to the FDA for ATIS's Dermagraft engineered human dermis with synthetic epidermis to treat diabetic foot ulcers. Earlier this year, the partners modified the inclusion criteria for the pivotal trial, and amended the statistical plan for analyzing data from the trial (see BioCentury, March 6). The amended trial, which ATIS said was suggested by the FDA, enrolled only patients whose ulcers have existed for >6 weeks. In these patients, ATIS said that Dermagraft healed significantly more ulcers than the control treatment (p=0.023). ...