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Integra LifeSciences Receives FDA Approval and CE Mark for INTEGRA(R) Dermal Regeneration Template - Terminally Sterilized
10/11/2004 6:00:29 AM

PLAINSBORO, N.J., Oct 11, 2004 (PRIMEZONE via COMTEX) -- Integra LifeSciences Holdings Corporation (IART) today announced that Integra LifeSciences has received approval from the United States Food and Drug Administration (FDA) and CE Mark Certification in the European Union from TUV Product Service to sell the terminally sterilized version of its currently-marketed INTEGRA(R) Dermal Regeneration Template in the United States and Europe.

INTEGRA(R) Dermal Regeneration Template - Terminally Sterilized (IDRT-TS) offers customers numerous improvements over the existing INTEGRA(R) Dermal Regeneration Template. Integra is launching IDRT-TS this week at the American Society of Plastic Surgeon's 2004 Annual Meeting in Philadelphia and plans to launch the product in Europe shortly thereafter. Integra will sell IDRT-TS through its Plastic and Reconstructive Surgery sales force domestically, through its direct sales forces in Germany, England and France, and through distributors in the remainder of Europe.

... Integra estimates that the market opportunity for products used in plastic and reconstructive surgery to treat burns and scar contractures is approximately $220 million.

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