LITTLE FALLS, N.J., Nov. 1, 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 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 27th, 2016 regarding its product NovaDerm®.
NovaDerm®, which recently received its orphan-drug designation from the FDA, is a regenerative cell therapy that has the potential to re-grow a patient's own skin in a cell therapy manufacturing facility by harvesting a small, stamp-size skin biopsy.
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.
"We are very pleased with the outcome of the pre IND meeting," said Randall McCoy, CEO of Regenicin. "Our agreement with the FDA on the pathway to move forward has been clarified and confirmed. We will finalize our IND submission and continue to prepare for clinical trials."
About Regenicin
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.
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.
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NovaDerm®, which recently received its orphan-drug designation from the FDA, is a regenerative cell therapy that has the potential to re-grow a patient's own skin in a cell therapy manufacturing facility by harvesting a small, stamp-size skin biopsy.
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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.
"We are very pleased with the outcome of the pre IND meeting," said Randall McCoy, CEO of Regenicin. "Our agreement with the FDA on the pathway to move forward has been clarified and confirmed. We will finalize our IND submission and continue to prepare for clinical trials."
About Regenicin
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.
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.
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SOURCE Regenicin, Inc.
