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OrCel is a bilayered cellular matrix product developed by Forticell Bioscience (formerly Ortec International). It is a living skin substitute consisting of normal human allogeneic skin cells—specifically epidermal keratinocytes and dermal fibroblasts—cultured in two layers on a Type I bovine collagen sponge. The product functions by providing a structural scaffold and expressing a variety of cytokines and growth factors (including FGF-1, VEGF, and TGF-beta) that stimulate the patient's own cells to promote wound healing and tissue regeneration. OrCel was the first product to receive both Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) from the FDA for different indications, specifically for donor site wounds in burn patients and hand reconstruction in patients with recessive dystrophic epidermolysis bullosa (RDEB).
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