Regenicin Completes Pre-IND Meeting with Food and Drug Administration for its New Autologous Cultured Skin Substitute, NovaDerm
November 01, 2016 at 06:30 am EDT
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Regenicin, Inc. announced that they have completed the Pre-IND (Investigational New Drug) meeting via teleconference with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) on October 27, 2016 regarding its product NovaDerm. A Pre-IND meeting provides an opportunity for open communication between a sponsor and FDA/CBER/OCTGT to discuss planned IND content and to obtain advice from these centers. The FDA addressed the Company's questions and provided guidance on the NovaDerm development pathway moving forward.
Regenicin, Inc. is a biotechnology company that is focused on the development of regenerative cell therapies to restore the health of damaged tissues and organs. The Company is focused on developing and commercializing a lifesaving technology through the introduction of tissue-engineered skin substitutes to restore the qualities of healthy human skin for use in the treatment of burns, chronic wounds and a range of plastic surgery procedures. Its product, NovaDerm, is a multi-layered tissue-engineered skin prepared by utilizing autologous skin cells. NovaDerm is a graftable cultured epithelium skin substitute containing both epidermal and dermal components. It is focused on developing its product, TempaDerm. TempaDerm cells develop banks of cryo-preserved (frozen) cells and cultured skin substitutes to provide a continuous supply of non-allogenic skin substitutes to treat smaller wound areas in patients, such as ulcers. Its application is used for the treatment of chronic skin wounds.
REGENICIN, INC. 
