Ortec receives FDA PMA for use of tissue engineered skin in donor site wounds in burn victims.

Ortec International, Inc., New York, NY announced it has received FDA Premarket Approval (PMA) for its OrCel tissue engineered skin substitute for use in the treatment of donor site wounds in burn victims. Donor site wounds are created when healthy skin is procured from an uninjured part of the body to cover a burned area on another part of the body. The company says more than 1.25 million people are treated annually for burns at medical facilities in the US.

Composite cultured skin (CCS) is composed of human skin cells, which are derived from infant foreskin and placed on a porous collagen scaffold. Ortec says after CCS is placed on the wound, the cells in the collagen scaffold secrete growth factors that, among other things, attract the host's capillaries. Over time, the host cells replace those of the CCS, and the repaired skin is the patient's own.

Ortec received a unanimous recommendation in favor of approval of its OrCel product from the FDA's General and Plastic Surgery Devices Advisory panel in July.