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Genzyme Announces Presentation of New Positive Data on Carticel(R)
Date:3/10/2008

st cell therapy to be approved by the FDA. First introduced in March of 1995, Carticel received accelerated approval from the FDA in August of 1997 after the FDA instituted specific cell therapy guidelines. Under accelerated approval, the FDA required Genzyme to conduct confirmatory post-marketing clinical studies. Genzyme successfully completed the confirmatory studies and, in June of 2007, the FDA deemed the commitment satisfied.

To learn more about Carticel please visit http://www.carticel.com.

Cell Therapy Expertise at Genzyme

Genzyme has more than a decade of experience in developing and manufacturing autologous cell therapy products that have been used to treat thousands of patients. Epicel(R) (cultured epidermal autografts), a cell therapy for treating patients with severe burns, is also manufactured by Genzyme. Together, Carticel and Epicel represent the first such products ever brought to market in the United States, providing Genzyme with superior scientific and commercial expertise in this field.

About Carticel

CARTICEL is for autologous use and is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reco
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SOURCE Genzyme Corporation
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