מתוך medicontext.co.il
WASHINGTON (Reuters Health) – Advanced Tissue Sciences Inc. and its partner Smith & Nephew plc said on Monday that they have received clearance from the US Food and Drug Administration to market their living skin graft for the treatment of chronic diabetic foot ulcers.
The companies jointly announced that the FDA approved their premarket approval application for Dermagraft, a skin substitute composed of human fibroblasts, a human extracellular matrix and a bioabsorbable scaffold. The FDA action marks the first approval of a living dermal substitute in the US.
Dr. Gail K. Naughton, president of Advanced Tissue Sciences, said that the companies are now beginning commercial launch activities and are seeking approval for third-party reimbursements.
Chris O'Donnell, CEO of the global wound care products distributor, told Reuters in an interview on Monday that Dermagraft is also being tested for leg ulcers.
In Europe, Dermagraft is expected to receive regulatory approval in around 2 years' time.
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