LITTLE FALLS, N.J., Nov. 17, 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, today announced that they have signed a supplier agreement with Pure Med Farma, LLC (PMF) to provide closed herd collagen for the production of its proprietary collagen scaffolds for the manufacturing of NovaDerm®. PMF is a related1 biotechnology company dedicated to bringing safe Animal Source Materials (ASMs) and Xenotransplantation materials to the global healthcare market using proprietary closed herd technology and biosecurity practices.
The agreement with PMF states Regenicin will receive priority pricing and guaranteed inventory availability. This is a key milestone, as guidance documents from the U.S. Food and Drug Administration (FDA) clearly state that any product requesting approval to enter clinical trials will be denied until the applicant presents evidence that components derived from animal sources were obtained from closed herds.2
According to Randall McCoy, Chief Executive Officer of Regenicin, "Regenicin will only use bovine closed herd collagen to produce NovaDerm. Using collagen that comes from a bovine closed herd provides a significant breakthrough in safety, as closed herd quality systems are designed to minimize exposure to pathogens which could be transferred to humans when using animal components for healthcare."
About Closed Herds
Closed herd animal products ensure that controls have been put into place that prevent animals from being exposed to outside pathogens and avoid the use of hormones and unnecessary antibiotics that could jeopardize human health. Products from a closed herd can be traced back to a specific certified animal, its parents, its health, its food supply and more.
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.
About Pure Med Farma LLC
PMF is a biotechnology company dedicated to bringing safe Animal Source Materials (ASMs) and Xenotransplantation materials to the U.S. Market and throughout the world using proprietary closed herd technology and biosecurity practices. PMF has the expertise and resources needed to satisfy the regulatory requirements and controls to meet the demand for safe, viral and disease free life-saving components. PMF is the first and only known provider of bovine closed herd animal sourced materials (ASM's) to file with the FDA. Please visit the company website at www.puremedfarma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Pure Med Farma LLC, is a development stage company in which Regenicin's CEO and CFO are each part owners.
Regenicin entered into an interest bearing loan agreement with PMF in order to satisfy Regenicin's FDA IND information requirements for animal sourced material.
2 Guidance for Industry Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER)2003
SOURCE Regenicin, Inc.