Ortec seeks OK of OrCel for skin disorder

NEW YORK, May 30 (UPI) -- Ortec said Tuesday it has filed for a "humanitarian device" exemption to get OrCel cleared to treat epidermolysis bullosa.

The maker of stem-cell therapies said it expects its filing with the Food and Drug Administration will allow it to market a "cryopreserved" or frozen formulation of OrCel by mid-July.

OrCel is for use in patients with the rare congenital skin disorder known as Recessive Dystrophic Epidermolysis Bullosa.

Specifically, the product is for use in patients with RDEB who are undergoing hand reconstruction, as well as to cover donor sites created during the surgery.

The FDA approved a non-frozen version of OrCel to treat the condition in February 2001.

The HDE exemption would allow Ortec to secure approval of the frozen formulation of OrCel without having to submit additional clinical data.

The exemption is reserved for devices that treat conditions affecting fewer than 4,000 people in the United States.

RDEB -- the most severe form of epidermolysis bullosa -- is marked by painful ulcerations and permanent scarring that causes deformity of the hands and feet.

Surgery is often performed on RDEB patients to separate the extremities, giving them greater movement. But the surgery requires the need for replacement skin from another part of the patient's body.