Regenicin Soars But May Head Higher Post FDA Orphan Product Status Approval Print E-mail
By M.E.Garza   
Wednesday, 13 June 2012 03:41
icon_marketmoverShares 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 prices headed 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.

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™. 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™ 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.

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