FDA Grants Orphan-Drug Designation for Regenicin's NovaDerm®
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/
"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."
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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.
About NJIT
One of the nation’s leading public technological universities, NJIT is a top-tier research university that prepares students to become leaders in the technology-dependent economy of the 21st century. NJIT’s multidisciplinary curriculum and computing-intensive approach to education provide technological proficiency, business acumen and leadership skills. With an enrollment of 11,300 graduate and undergraduate students, NJIT offers small-campus intimacy with the resources of a major public research university. NJIT is a global leader in such fields as solar research, nanotechnology, resilient design, tissue engineering and cybersecurity, in addition to others. NJIT ranks fifth among U.S. polytechnic universities in research expenditures, topping $120 million, and is among the top 1 percent of public colleges and universities in return on educational investment, according to PayScale.com. NJIT has a $1.74 billion annual economic impact on the State of New Jersey. For more information on NJIT, as well as its research and academic programs, please visit the university website at www.njit.edu.
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