Ortec International, Inc., a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, May 30 announced that as a result of ongoing discussions with the Food and Drug Administration (FDA), Ortec expects to file an HDE supplement to obtain marketing approval for use of OrCel in RDEB patients by mid-July 2006.
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ORTEC EXPECTS TO FILE HUMANITARIAN DEVICE EXEMPTION (HDE) APPLICATION WITH FDA REQUESTING MARKETING APPROVAL OF CRYOPRESERVED ORCEL FOR USE IN EPIDERMOLYSIS BULLOSA PATIENTS
June 1, 2006