Advanced Tissue Shares Fall on FDA Warning

Advanced Tissue Sciences Inc. shares fell 17% after release of a warning letter from federal regulators cast doubt on whether the company can get its Dermagraft skin-healing product approved. Advanced Tissue stock fell $1.56 to close at $7.88 on Nasdaq, with shares earlier hitting a 52-week low of $7.13. Shares fell 20% a week ago after the company revealed that it had received a warning letter and that the Food and Drug Administration still had “concerns” about whether Dermagraft should be approved. The letter said one of Advanced Tissue’s products had been linked to a death and listed several concerns about the company’s manufacturing conditions. The FDA also said the La Jolla-based company didn’t submit the correct paperwork after learning of a death connected to one of its products. Advanced Tissue said that it still expects Dermagraft to be approved. Dermagraft is intended to be used in healing stubborn diabetic foot ulcers.