The FDA has granted orphan-drug status to Regenicin’s (OTC:RGIN) NovaDerm cultured skin substitute.
In a statement, the company said it 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 orphan-drug designation for NovaDerm covers 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.