Regenicin soars but may head even higher post FDA orphan product status approval for "skin substitute"
(Thomson Reuters ONE) -
Shares of Regenicin, Inc. (OTC Bulletin Board: RGIN) are likely headed
significantly higher as the micro-cap firm plans to begin commercialization of
FDA approved orphan product skin substitute for burn victims as soon as
possible.
Investors pushed the stock 76.47% higher from $0.13 a share to $0.27 on Tuesday
and headed even higher After Hours to 0.280 +0.010 (3.70%), following a late
afternoon news report that the firm had been granted orphan product status
approval by the U.S. Food and Drug Administration.
Over 4 million shares of the stock traded within a couple of hours, compared to
a daily average of 136K after the company's tissue replacement therapy, which
creates a substitute skin to treat catastrophic burn victims using the patients'
own skin cells finally received the orphan product designation which investors
had been waiting for.
Sources tell BioMedReports that the company plans to begin commercialization of
the technology, which was tested extensively in more than 150 pediatric and
adult catastrophic burn patients at Shriners Hospital for Children (SHC) in
Cincinnati, Ohio, within 30 days.
Although Regenicin owns the license for the ground-breaking skin treatment we
first told our readers about in late 2010, Swiss biopharmaceutical company Lonza
Group Ltd. (PINK:LZAGF) retains the exclusive manufacturing rights for the
therapeutic candidate, PermaDerm(TM). Analysts see this as a product which could
help revolutionize the way wounded warriors and civilians recover from severe
burns and wounds.
If the overhang that haunted prices from the start has truly cleared up, shares
could rise significantly in the days ahead as the company expects to fetch as
much as $300K per treatment for pediatric patients and close to $600K per
treatment of each adult patient. While those costs may seem high, industry
observers point out that the therapy may actually save healthcare costs by
reducing the need for multiple surgeries, lessening the risk of infection and
reducing the amount of time a patient spends in intensive care units. Having
orphan status also gives the company up to seven years of market exclusivity for
treating up to 4 thousand patients per year. It also grants it tax relief and
various exemptions from certain fees.
PermaDerm(TM) is the only tissue-engineered skin prepared from autologous
(patient's own) skin cells from both the epidermal and dermal skin layers. A
small sample of the patient's skin can be expanded in the laboratory to cover a
wound site that extends over 50% of the patient's body. These self-to-self skin
grafts are intended to form permanent wound closure that is not rejected by the
patient's immune system, a critical possibility in porcine or cadaver skin
grafts used today.
In November of 2012, Switzerland based Lonza announced more than $18 million in
U.S. defense funding to develop their skin substitute grown from the patient's
own cells. Soon after, in early January 2011, Regenicin's CEO, Randall McCoy
told us during a meeting in New York City that the burn treatment market in the
US alone represents a $3 Billion Dollar opportunity for his company.
The new designation by the FDA, coupled with a strong management team and board
of directors, optimally positions Regenicin to finally begin to achieve its
corporate goals and mission. We continue to believe that Regenicin is in an
unusual and unique position despite a very rocky start to their business plan
nearly two years ago.
On behalf of the investors and burn victims who can take advantage of this new
treatment option, we continue to be long the stock and have high hopes that they
may be able to fulfill their promise to early investors by transforming into a
billion dollar company in a shorter period than most expect.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: BioMedReports via Thomson Reuters ONE
[HUG#1619337]
Datum: 13.06.2012 - 11:27 Uhr
Sprache: Deutsch
News-ID 155933
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