Regenicin, Inc. is a biotechnology company with corporate headquarters in Little Falls, New Jersey. The Company specializes in the development of regenerative cell therapies to restore the health of damaged tissues and organs.
Founded in 2010, Regenicin is playing a vital role in the development of the therapeutic candidate, PermaDerm™. This is an innovative technology that uses a patient’s own skin cells to generate living, tissue-engineered skin for the treatment of catastrophic burns. Regenicin, Inc. is now working to bring PermaDerm™ to market.
The Company’s business model is to identify promising new therapeutic candidates that address unmet needs in growing markets. They will then look to develop the most strategic, economical and expeditious pathways for achieving regulatory approval by the FDA. Furthermore, they look to create a commercialization pipeline for bringing these new candidates to market once FDA approved.
PermaDerm™ consists of cultured fibroblast and kerotinocytes on an absorbable collagen substrate (biomedical polymer). This produces a living skin substitute that contains epidermal and dermal components. In preclinical studies this model has been shown to generate a functional skin barrier and in clinical studies to promote closure and healing of burns.
With the PermaDerm™ technology, a small harvested section of the patient’s own skin can be grown to graft an area one hundred times its size in as little as thirty days. PermaDerm™ is undergoing development to be the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of epidermal and dermal layers. The intention of this living, self-to-self skin graft tissue is to form permanent skin tissue that the immune system of the patient will not reject.
Regenicin, Inc. is currently working with their contract manufacturer to prepare for pre-market approval of PermaDerm™ from the FDA. PermaDerm™ shows promise to save lives, reduce healthcare costs by decreasing a patient’s stay in the Critical Care Unit and reduce the need for additional surgeries. The PermaDerm™ technology has undergone clinical testing in more than 150 pediatric, catastrophic burn patients.
Regenicin’s contract manufacturer, Lonza Biosciences, at their cGMP facility in Walkersville, Maryland, will produce PermaDerm™ and related product candidates. Upon approval by the FDA, the product candidates will ship directly to the treating physicians with all the materials needed to treat catastrophic burn patients.
Regenicin, Inc. continues to work to develop other cell therapy technologies. They have a priority focus to develop future therapeutics in the diabetes and chronic wounds (including ulcers) areas. Their priority focus is also to develop adult stem cell therapies and reconstructive surgery applications.