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Epicel(TM) Wins Marketing Approval for Severe Burn Victims
Date:10/29/2007

First FDA-Approved Xenotransplantation Device

CAMBRIDGE, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) announced today that the U.S. Food and Drug Administration (FDA) has granted Epicel(TM) (cultured epidermal autografts) marketing approval under the Humanitarian Device Exemption (HDE) for the treatment of life-threatening wounds resulting from severe burns. It is a product that can provide permanent skin replacement for burn victims, and is made from a patient's own skin cells and then grown on a layer of mouse cells to enhance growth. Epicel is the first xenotransplantation-classified product to be approved in the U.S. because of its inclusion of animal cells.

"We are pleased that the FDA has recognized the importance of Epicel for patients with severe burns," said Alicia Secor, vice president and general manager of the Biosurgical Specialties group within Genzyme that manufactures Epicel. "Epicel has played a critical role in the recovery process of hundreds of patients who have suffered through the trauma of life-threatening burns."

Epicel has been used in more than 1,000 patients with burn injuries since it was introduced in 1988. The product had been considered a banked human tissue until 1996 when FDA announced that manipulated autologous cell-based products used for structural repair or reconstruction required regulatory oversight. Genzyme applied for regulatory approval of Epicel in 1999.

Epicel is supplied in grafts, which each consist of a sheet of cultured epidermal cells attached with stainless steel surgical clips to a backing of petrolatum gauze. Enough skin can be grown from a biopsy the size of a postage stamp to cover the entire body.
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SOURCE Genzyme Corporation
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