Dermagraft, a human skin replacement for the treatment of diabetic foot ulcers has been recommended to the FDA for approval on the condition that Advanced Tissue Sciences, Inc. and its partner Smith & Nephew plc perform a post marketing study.
Dermagraft is a living skin replacement produced from foreskin tissue removed at circumcisions which is then cultured in a laboratory. Dermagraft is then frozen for storage and shipped to physicians to be administered to patients.
In the U.S., it is estimated that diabetic foot ulcers affect nearly 15 percent of the 16 million patients with diabetes. The vote to recommend approval by the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to the U.S. FDA was made after the company presented clinical data demonstrating that diabetic foot ulcers could be completely healed within 12 weeks with the use of Dermagraft.
Advanced Tissue Sciences, Inc. based in La Jolla, Calif., and Smith & Nephew plc are pursuing the worldwide commercialization of Dermagraft through a fifty-fifty joint venture.