FDA Grants Orphan-Drug Designation for Regenicin's
Post# of 99
Posted On: 08/29/2016 11:20:43 PM
FDA Grants Orphan-Drug Designation for Regenicin's NovaDerm® Cultured Skin Substitute
LITTLE FALLS, N.J., Aug. 29, 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, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation status to the company's NovaDerm® cultured skin substitute. The Company believes NovaDerm to be the only autologous cultured skin substitute prepared from the patient's own skin cells consisting of both epidermal and dermal layers previously designated by the FDA as a biologic for treatment of patients with deep-partial or full-thickness thermal burns greater than or equal to 30% total body surface area. The FDA has granted orphan-drug designation status to NovaDerm for treatment of burns requiring skin grafting.
NovaDerm consists of harvesting a small section of the patient's skin to be grown to graft an area over a hundred times its size in as little as 28 days. These living, self-to-self skin graft tissues are intended to form permanent skin tissues that will not be rejected by the immune system of the patient, a critical possible problem with porcine or cadaver temporary coverings used today for catastrophic burn patients. NovaDerm is being designed to save lives and reduce scarring, the need for additional surgeries, the patient pain and suffering time as well as healthcare costs by decreasing the patient's stay in the critical care unit.
The FDA's designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies. For more information on the FDA's policies governing the development of Orphan drugs for rare diseases and conditions, as well as the publication of today's designation announcement (updated monthly) on this matter, please visit the FDA website links at:
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/
www.accessdata.fda.gov/scripts/opdlisting/oopd/
"We are very excited about this Orphan Status designation for NovaDerm," said Randall McCoy, CEO of Regenicin. "This is extremely good news and a huge step for the product. I am very proud of our team that made this possible."
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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-for-regenicins-novaderm-cultured-skin-substitute-300319400.html
SOURCE Regenicin, Inc.
LITTLE FALLS, N.J., Aug. 29, 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, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation status to the company's NovaDerm® cultured skin substitute. The Company believes NovaDerm to be the only autologous cultured skin substitute prepared from the patient's own skin cells consisting of both epidermal and dermal layers previously designated by the FDA as a biologic for treatment of patients with deep-partial or full-thickness thermal burns greater than or equal to 30% total body surface area. The FDA has granted orphan-drug designation status to NovaDerm for treatment of burns requiring skin grafting.
NovaDerm consists of harvesting a small section of the patient's skin to be grown to graft an area over a hundred times its size in as little as 28 days. These living, self-to-self skin graft tissues are intended to form permanent skin tissues that will not be rejected by the immune system of the patient, a critical possible problem with porcine or cadaver temporary coverings used today for catastrophic burn patients. NovaDerm is being designed to save lives and reduce scarring, the need for additional surgeries, the patient pain and suffering time as well as healthcare costs by decreasing the patient's stay in the critical care unit.
The FDA's designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies. For more information on the FDA's policies governing the development of Orphan drugs for rare diseases and conditions, as well as the publication of today's designation announcement (updated monthly) on this matter, please visit the FDA website links at:
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/
www.accessdata.fda.gov/scripts/opdlisting/oopd/
"We are very excited about this Orphan Status designation for NovaDerm," said Randall McCoy, CEO of Regenicin. "This is extremely good news and a huge step for the product. I am very proud of our team that made this possible."
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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-for-regenicins-novaderm-cultured-skin-substitute-300319400.html
SOURCE Regenicin, Inc.
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