FDA grants PermaDerm (Regenicin) for Skin Grafts orphan status

The FDA has granted Orphan Status approval for PermaDerm, from Regenicin, the first tissue-engineered skin prepared from autologous skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients requiring Skin Grafts. The FDA had previously designated PermaDerm to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm is the first skin replacement technology to receive this Biological/drug designation. It consists of harvesting a small section of the patient's own skin to be grown to graft an area one hundred times its size in as little as thirty days. These living, self-to-self skin graft tissues are intended to form permanent skin tissues that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today. To date, the technology has been clinically tested in over 150 pediatric and adult, catastrophic burn patients with very encouraging results.