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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