LITTLE FALLS, N.J., Feb. 9, 2016 /PRNewswire/ -- Regenicin, Inc. (OTC Bulletin Board: RGIN), a biotechnology company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, recently reported the Company's operating results for 2015 and milestones for the first quarter of 2016.
As the Company described in its recent 10-K filing with the SEC, a year and half after filing the lawsuit against Lonza Walkersville, Inc., and Lonza America, Inc. (the "Lonza Litigation"), Regenicin began the new 2015 fiscal year in the process of consummating an agreement to sell certain assets, including the Lonza Litigation, to Amarantus Bioscience Holdings, Inc. (the "Amarantus Agreement"). The Amarantus Agreement was finally consummated at the end of February 2015, with their final payment to the company and the transfer/dismissal of the Lonza Litigation. As part of the agreement, The PermaDerm® trademark and PermaDerm intellectual property was transferred to Amarantus. The proceeds recognized from the sale allowed Regenicin to move forward with the development of its own cultured skin substitute, NovaDerm™.
At the start of 2015, Regenicin reached an agreement with an internationally recognized institution to provide key scientific information for the proposed new autologous engineered skin substitute, NovaDerm. NovaDerm is a regenerative cell therapy that has the potential to re-grow a patient's own skin in a laboratory by harvesting fibroblast and keratinocytes from a small harvested section of healthy skin. The scientific investigation is expected to provide vital information that will to lead to product improvements in the form of the best starting materials, an extended shelf life, and potentially reducing the manufacturing time of the product. Regenicin expects this research will be part of its application to the Food and Drug Administration (FDA) for approval to start clinical trials, and will provide the basis of the tech transfer to the Company's chosen manufacturers.
In addition, in recent discussions with the FDA, Regenicin was informed that NovaDerm will be classified as a "Biologic" since the technology uses a novel approach and new components for developing the collagen matrix. NovaDerm would thus be the first and only autologous cultured skin substitute designated solely as a Biologic for treatment of burns greater than 30% of the total burn surface area. This designation not only serves as a point of product differentiation, but will also open up the opportunity for Regenicin to pursue Biologic Orphan designation for NovaDerm.
Regenicin has identified an FDA registered cGMP cultured cell manufacturers to produce the cultured skin substitute for use in clinical trials and to produce the product once it is approved. Related to the FDA approval pathway, Regenicin will be selecting a Clinical Research Organization to assist us in the actual clinical trials. Regenicin expects to initiate clinical trials for NovaDerm _ utilizing the proprietary collagen-based scaffold in the fourth quarter of 2016.
Moving forward Regenicin is working on the following contracts which it expects to be complete by the end of the first quarter of 2016:
The first contract is with the component supplier of "Closed Herd" collagen. Collagen is an integral component of the platform on which the skin cells are grown. Closed Herds prevent animals from being exposed to outside pathogens, as well as unnecessary antibiotics and hormones that could jeopardize human health. Recent guidance documents from the FDA have emphasized the importance of traceability of animal source materials (ASMs) used for healthcare. New guidance documents are scheduled to be announced at the end of March 2016.
The second contract is with a manufacturer of collagen scaffolds. Regenicin is currently working with a global company considered to be a leading medical device materials development manufacturer and a specialist in the production of collagen scaffolds.
The third contract is a cGMP cell therapy manufacturing contract. This agreement will be with the ultimate producer of the actual NovaDerm™ skin product. Cell therapy is very specialized and costly manufacturing, involving clean room production. Working with this manufacturer, Regenicin will be developing a novel approach that will substantially reduce the cost of manufacturing, particularly for the limited production required for the clinical trials. "We wish to thank our shareholders for their patience and loyalty during this 'rebuilding' period," said Randall McCoy, CEO of Regenicin. "We promise a new era of communication as we accomplish the various milestones toward the initiation of clinical trials targeted for Q4 2016."
Regenicin, Inc. (OTC Bulletin Board: RGIN), is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world-class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. The company is publicly traded with headquarters in New Jersey. For more information on Regenicin, Inc., as well as its technologies and products, please visit the company website at www.regenicin.com.
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