The Food and Drug Administration (FDA) has granted Orphan Drug designation to Regenicin’s cultured skin substitute, NovaDerm, for the treatment of burns requiring skin grafting.

NovaDerm is an autologous skin substitute composed of cultured fibroblast and kerotinocytes on an absorbable collagen substrate (biomedical polymer). It consists of both epidermal and dermal layers harvested from a small section of the patient’s skin to be grown to graft and generate a functional skin barrier in as little as 28 days. Unlike porcine or cadaver temporary coverings that are used for extensive burn patients today, the Novaderm graft intends to form permanent skin tissues that will not be rejected by the patient’s immune system. 

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Regenicin is developing NovaDerm to reduce pain, scarring, and the need for additional surgeries in patients with catastrophic, full-thickness thermal burns covering over 50% of the total body surface area.

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