FDA Approves Dermagraft

Smith & Nephew Plc 1 October 2001 1 October 2001 FDA Approves Dermagraft 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.' Enquiries: Chris O'Donnell, Chief Executive Tel: +44 (0) 20 7401 7646 Smith & Nephew plc Peter Hooley, Finance Director Tel: +44 (0) 20 7401 7646 Smith & Nephew plc Margaret Stewart, Group Director of Corporate Affairs Tel: +44 (0) 20 7401 7646 Smith & Nephew David Yates Tel: +44 (0) 20 7831 3113 Financial Dynamics Note to Editors Smith & Nephew and Advanced Tissue Sciences created their Dermagraft joint venture in 1996, and made a PMA application for Dermagraft in 1996. Following further clinical trials at the request of the FDA, a further PMA was submitted in August 2000. Dermagraft is a human based product, manufactured from human fibroblast seeded onto a bioabsorbable mesh scaffold. During the manufacturing process, the human fibroblasts divide and grow, and secrete human dermal collagen, matrix proteins and growth factors to create a three-dimensional human dermal substitute containing metabolically active living cells. It can be shipped frozen, with a 6-month shelf life, thereby allowing doctors flexibility in scheduling patient visits. Its effectiveness was established in patients who were allowed to remain ambulatory during their treatment. Smith & Nephew (London : SN. NYSE : SNN) is a global medical company employing around 7000 people, and with operations in 34 countries and established sales in 90 countries. It markets technologically innovative products principally in the areas of orthopaedics, endoscopy and wound management to deliver cost effective solutions, significant patient advantages and real patient benefits. Smith & Nephew is the world's leading wound management company with a portfolio of technologically advanced tissue repair products, particularly for chronic wounds such as leg ulcers, pressure sores and burns. Advanced Tissue Sciences (NASDAQ : ATIS) is a tissue engineering company utilising its proprietary core technology to develop and manufacture human-based tissue products for tissue repair and transplantation.
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