Ortec to seek FDA approvals for its cryopreserved OrCel for the treatment of congenital skin disorder

By Lisa Kerner

Charlotte, N.C., July 6 - Ortec International, Inc. said that it plans to submit a Humanitarian Device Exemption supplement to the Food and Drug Administration seeking marketing approval for use of cryopreserved OrCel in the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a congenital skin disorder characterized by ulcers, scarring and deformity of hands and feet.

The FDA has already advised the company it could approve, without additional data, an HDE supplement allowing for the use of cryopreserved OrCel in RDEB patients undergoing hand reconstruction including the donor sites (area where skin was removed from another part of the patient's body).

Ortec expects to complete the trial confirming cryopreserved OrCel's superiority in the treatment of difficult-to-heal venous leg ulcers compared to the standard of care therapy within the next six weeks.

Data from the current trial will be combined with efficacy data from Ortec's 12-week pivotal trial and used in the company's supplemental Pre-Market Approval application to the FDA planned for the fourth quarter.

New York-based Ortec specializes in the development and commercialization of products combining advanced cell technology and advanced biomaterials.

© 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.