Ortec to file HDE application for marketing approval of OrCel for use in Epidermolysis Bullosa

By Lisa Kerner

Erie, PA., May 30 - Ortec International, Inc. said it expects to file a Humanitarian Device Exemption (HDE) supplement with the Food and Drug Administration by mid-July for use of OrCel in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) undergoing hand reconstruction and for the area where skin is removed from the patient.

The FDA previously granted Ortec an HDE to market the non-frozen version of OrCel, according to a company news release.

An HDE is similar in both form and content to a Pre-Market Approval application. However, the FDA may grant approval for an HDE based on more limited clinical experience than that required for a PMA.

RDEB, the most severe form of Epidermolysis Bullosa, is a congenital skin disorder characterized by painful ulcerations and widespread, permanent scarring resulting in deformity of the hands and feet.

New York City-based Ortec develops and commercializes products for regenerative medicine and stem cell therapy.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.