Regenicin, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation status to the company's NovaDerm® cultured skin substitute. The company believes NovaDerm to be the only autologous cultured skin substitute prepared from the patient's own skin cells consisting of both epidermal and dermal layers previously designated by the FDA as a biologic for treatment of patients with deep-partial or full-thickness thermal burns greater than or equal to 30% total body surface area. The FDA has granted orphan-drug designation status to NovaDerm for treatment of burns requiring skin grafting. NovaDerm consists of harvesting a small section of the patient's skin to be grown to graft an area over a hundred times its size in as little as 28 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 possible problem with porcine or cadaver temporary coverings used for catastrophic burn patients. NovaDerm is being designed to save lives and reduce scarring, the need for additional surgeries, the patient pain and suffering time as well as healthcare costs by decreasing the patient's stay in the critical care unit. The FDA's designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.