LITTLE FALLS, N.J., March 8, 2011 /PRNewswire/ -- PermaDerm™, an engineered skin substitute which is being developed to be the only tissue-engineered skin prepared from a patient's own skin cells, has been attracting national media attention ever since it was announced that the U.S. Department of Defense awarded more than $18 million in funding for the development and commercialization of the therapeutic candidate for the treatment of severe burns among U.S. troops and civilians.
Since November, PermaDerm has received coverage by the Associated Press, the LA Times, UPI, Bloomberg Business Week, and several other national publications. In addition, ABC News featured a story in their on-line edition on eight-year old, Alfred Real and his return home following a severe burn over 80% of his body. The FDA allowed Real to be treated with the engineered skin substitute this past summer.
Regenicin, Inc. (OTC Bulletin Board: RGIN), through its know-how license and other contractual rights, is working with PermaDerm's manufacturer to obtain FDA approval for the commercial sale of PermaDerm. The recent funding given to the manufacturer from the D.O.D. will, among other things, assist in advancing the adult clinical trials to be conducted in connection with the FDA approval process. Regenicin will continue working toward its goal with the manufacturer to achieve interim and final federal regulatory approval.
PermaDerm has already been used to treat more than 150 pediatric, catastrophic burn victims through an Investigation Device Exemption issued by U.S. Food and Drug Administration (FDA). The initial clinical trials will contain 10 patients, both male and female, between the ages of 18 and 40, who suffer full thickness burns over a large area of their body. These trials and future trials will take place at 2 sites, the United States Army Institute of Surgical Research at Fort Sam Houston and a second site still to be determined.
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.
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SOURCE Regenicin, Inc.