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Forticell Bioscience, formerly known as Ortec International, was a biotechnology company specializing in regenerative medicine and tissue engineering. The company's primary focus was the development of OrCel, a bilayered cellular matrix composed of allogeneic keratinocytes and fibroblasts cultured on a bovine collagen sponge. OrCel received Humanitarian Device Exemption (HDE) approval from the FDA for treating patients with recessive dystrophic epidermolysis bullosa (RDEB) undergoing hand reconstruction surgery. Beyond RDEB, the company pursued clinical trials for OrCel in broader indications such as venous leg ulcers and diabetic foot ulcers. Despite its clinical progress, Forticell Bioscience encountered severe financial difficulties and filed for Chapter 11 bankruptcy in early 2009, subsequently ceasing operations.
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