Smith & Nephew, the global advanced medical devices group, is pleased to announce that its joint venture partner Advanced Tissue Sciences has received a letter from the US Food and Drug Administration (FDA) stating that the agency has approved the Premarket Approval Application (PMA) for Dermagraft in the treatment of chronic foot ulcers in patients with diabetes.
With this decision, Dermagraft, a tissue-engineered, living human dermal substitute, can now be made available for sale in the US. Compared to conventional therapy, Dermagraft is the only tissue-engineered dermal substitute to have shown clinically better healing in ambulatory, hard to heal diabetic foot ulcer patients.
Chris O'Donnell, Chief Executive of Smith & Nephew, said: "This is an excellent product and will, we believe, become a significant therapy to help many diabetic patients with hard to heal foot ulcers. Smith & Nephew is already the world's leading wound management company, and Dermagraft will join an established portfolio of major products that promote better and more efficient wound healing."
Dr Gail K Naughton, President of Advanced Tissue Sciences said: "We are very pleased to receive notification of the approval of our PMA application. While getting to this point has taken longer than we expected, we believe doctors and patients will realise that our human based product offers significant advantage over other treatments for hard to heal diabetic foot ulcers. Together with our partner Smith & Nephew, we are beginning our launch activities in the United States, which includes the process of seeking reimbursement coding."
Source: Smith & Nephew