FDAnews Device Daily Bulletin


June 12, 2006

Ortec International plans to file a humanitarian device exemption (HDE) application with the FDA for another version of its previously approved product to treat disfiguring skin burns, the company said May 30. Ortec develops and commercializes regenerative and stem cell products.

The product, Orcel, fuses two types of human skin cells into separate layers with cow collagen to create a cell "sponge." The FDA approved Ortec's premarket application (PMA) for Orcel as a wound dressing for burn victims in late August 2001.

Ortec is seeking the current HDE for its cryopreserved (freeze-dried) Orcel to treat recessive dystrophic epidermmolysis bullosa (RDEB), a rare congenital skin disorder that causes painful ulcerations and scarring leading to hand and foot deformities.

Surgery performed on RDEB patients to separate fingers and toes offers patients greater mobility of their digits but requires replacement skin from another part of the patient's body. Orcel can be used directly on the wound or to cover the "donor site," an area where skin has been removed to be used for a skin graft.

HDEs are reserved for devices that treat conditions affecting fewer than 4,000 people in the U.S. This latest HDE would allow Ortec to gain approval of its frozen Orcel without having to submit additional clinical data. The company is seeking approval to market the device to patients beginning in July.

Absorbed by the body, the living human skin cells used in Orcel produce proteins that can help heal wounds and "may stimulate a patient's own skin to heal itself," the FDA explains in its description of the product.