LITTLE FALLS, N.J.,
June 12, 2012 /PRNewswire/
-- Regenicin, Inc. (OTC Bulletin Board: RGIN) a biotechnology
company specializing in the development of and commercialization of
regenerative cell therapies to restore the health of damaged
tissues and organs, announced today that the Food and Drug
Administration (FDA) has granted Orphan Status approval for the
PermaDerm® product, the only tissue-engineered skin
prepared from autologous (patient's own) skin cells consisting of
both epidermal and dermal layers, that is indicated for
catastrophic burn patients. The FDA had previously designated
PermaDerm® to be a biological/drug (permanent skin
replacement) not a medical device (temporary skin replacement).
PermaDerm® is the only skin replacement technology to
receive this Biological/drug designation.
PermaDerm® consists of harvesting a small section of
the patient's own skin to be grown to graft an area one
hundred times its size in as little as thirty 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 possibility in porcine or cadaver
skin grafts used today. PermaDerm® is being designed to
not only save lives, but to reduce healthcare costs by decreasing
the patient's stay in the Critical Care Unit and to reduce the need
for additional surgeries. To date, the technology has been
clinically tested in over 150 pediatric and adult,
catastrophic burn patients with very encouraging results. For more
information on PermaDerm®, please visit the Regenicin
website (www.regenicin.com).
The FDA approval 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. 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 on this
matter, please visit the FDA website links at:
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/
and
www.accessdata.fda.gov/scripts/opdlisting/oopd/
"We are very excited about this Orphan Status designation for
PermaDerm®, " said Randall
McCoy, CEO of Regenicin. "This is extremely good news
and a huge step for the product, which we are all very proud
of."
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.
Contact:
10 High Court
Little Falls, NJ 17424
(646) 403-3581
PR@regenicin.com
info@regenicin.com
SOURCE Regenicin, Inc.
