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FDA Panel Recommends Dermagraft For Diabetic Foot Ulcers LA JOLLA, CA -- January 29, 1998 -- The United States Food and Drug Administration's general and plastic surgery devices panel of the medical devices advisory committee has recommended that the agency approve Advanced Tissue Sciences, Inc.'s Dermagraft(TM), a living human dermal replacement for the treatment of diabetic foot ulcers, with the condition that the company perform a post-marketing study. Dermagraft is produced by culturing human dermal fibroblasts (a type of cell commonly found in the dermal layer and in connective tissue) onto a biosynthetic scaffold. As the fibroblasts proliferate on the scaffold, they secrete important structural proteins and growth factors, generating a three-dimensional human dermis. Dermagraft is then frozen for storage and shipment to the treating physicians for implantation into patients. In the U.S., diabetic foot ulcers affect approximately 15 percent of the 16 million diabetic patients in their lifetime. E-mail this page to a friend or colleague! To print, use this version