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Epicel is an autologous cell therapy consisting of cultured epidermal autografts (CEA) used for the permanent replacement of skin in patients with severe burns. The product is indicated for adult and pediatric patients with deep dermal or full-thickness burns covering at least 30% of their total body surface area. Epicel is manufactured by taking a small biopsy of the patient's healthy skin and culturing the keratinocytes into large, multi-layered sheets. These sheets are then grafted onto the patient's burn wounds to provide a permanent, living skin cover. Originally developed by BioSurface Technologies and later owned by Genzyme and Sanofi, the product was acquired by Vericel Corporation in 2014 and is regulated by the FDA under a Humanitarian Device Exemption (HDE).
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