Advanced Tissue Science's stock gained 14 percent Wednesday onthe news that Dermograft-TC was recommended for approvalTuesday by an FDA advisory panel.
Dermograft-TC is a human-based bioengineered skin replacementdesigned to be a temporary covering for severe burn wounds. Theproduct, because of its unique and lifesaving qualities, had anexpedited review process, said Gail Naughton, Advanced TissueScience president and CEO.
"Our PMA went at the end of March," she said, "and we received arecommendation for approval in November. They have given usconcentrated treatment and we expect to continue to move in anexpeditious way."
Advanced Tissue Science, of La Jolla, Calif., develops andmanufactures human tissue replacement products for tissue repair andtransplantation. Naughton is one of the co-inventors of Dermograft-TC.
Pivotal clinical trial data demonstrated that Dermograft-TCsuccessfully reached its endpoint, the ability to adequately preparethe burn wound bed for successful autografting, performing equal toor better than the cadaver allograft control.
Also Dermograft-TC, the company said, performed significantlybetter than control with respect to important secondary endpointssuch as ease of removal, amount of excision required, amount ofbleeding upon excision and overall satisfaction ratings as a temporarycovering.
Naughton said that Advanced Tissue Science had been able to createa product that has the benefits of cadaver skin, but addresses thelimitations. "Dermograft-TC offers benefits of being sterile,reproducible and long lasting," she said.
"This product in testing has lasted as long as 74 days without beingreplaced and, after removal, has allowed for minimal bleeding fromthe wound bed," Naughton said.
Dermograft-TC is produced by culturing human dermal fibroblastsonto a commercially available biosynthetic material consisting of anultra-thin, semipermeable membrane bonded to nylon mesh. Thenylon mesh forms a 3-D scaffold for growth of the dermal tissue andthe membrane forms a synthetic epidermis. As the fibroblastsproliferate in the nylon mesh, they secrete structural proteins andgrowth factors, thereby generating a 3-D human dermal matrix.
Other products in development, Naughton said, include a productdesigned for diabetic foot ulcers, which is a permanent implant usingthe same cells and technology as the Dermograft-TC, and a cartilageimplant called Neocyte, which is designed to replace a patient'smissing cartilage.
Advanced Tissue Science stock (NASDAQ:ATIS) closed Thursdaydown $0.875. to $11.50. n
-- Frances Bishopp
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