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.
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.
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.
SOURCE Regenicin, Inc.
