Advanced Tissue Sciences Inc. has filed a premarket approval (PMA)application seeking approval to market Dermagraft-TC for treatingpatients with severe burns.
The La Jolla, Calif., company has been saying the filing would comeby June of this year. Advanced Tissue showed in pivotal studies thatthe engineered human dermal tissue, combined with a syntheticepidermal layer, was as good or better than cadaver skin in preparinga wound bed for autografting.
The FDA will expedite review of the PMA.
"We are pleased to submit what we believe is the first of many PMAsfor tissue replacement products," said Marie Burke, the company'sdirector of corporate communications. "There's a need for manyreplacement organs and we hope to be able to fill that need."
Burke said pricing of Dermagraft has not been determined. "We'resensitive to the economic issues facing burn centers as they strive toprovide the best possible care," Burke said. "Therefore we'reincorporating reimbursement and economic analyses into ourmarketing strategy. The final price will be determined when theseanalyses are completed."
Analysts have estimated the product will cost $3,000 per square foot.Burke said 1,500 patients per year in the U.S. are candidates forDermagraft treatment. Advanced Tissue plans to target 80 major U.S.burn centers with a sales staff of six to 10.
Another company product in clinical testing is Dermagraft, which isin pivotal studies as a treatment for diabetic foot ulcers. AdvancedTissue has a cartilage product it hopes to take into the clinic next yearand also is in preclinical studies with a cardiovascular product.
The company last month completed a public offering of 3 millionshares that grossed nearly $40 million. Its stock (NASDAQ:ATIS)gained 50 cents Friday to close at $14.25. n
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