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TOPIC: Regenicin, Inc (RGIN)

Regenicin, Inc (RGIN) 7 years 9 months ago #294

  • evilchild
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Once FDA gives approval this thing will rocket upwards with nothing holding it back.

Regenicin Changes Its Ticker Symbol to RGIN.OBFont size: A | A | A11:57 AM ET 11/10/10 | PR Newswire
Regenicin, Inc. (OTC Bulletin Board: RGIN.OB), a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, today announced the change of its ticker symbol on the OTC Bulletin Board from "WDST" to "RGIN.OB" effective at the opening of the market on Wednesday, November 10, 2010.

Regenicin CEO, Randall McCoy said the change in ticker symbol was made to better represent the company's name and future goals in advancing the field of regenerative medicine.

About Regenicin

The company who licensed the technology is called Regenicin (OTC: WDST). They acquired the license for that PermaDerm™ technology from Lonza with a goal of obtaining approval for use from the FDA.

PermaDerm™ is being developed to be the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of both epidermal and dermal layers. A postage stamp-sized biopsy of the patient’s skin can be grown in the laboratory to a sheet of PermaDerm™ one hundred times its area in as little as thirty days.

According to the company's own website, the technology utilizes the patient’s own cells to generate living, tissue-engineered skin. This skin can be used by catastrophic burn victims, patients with chronic wounds, and for use in reconstructive plastic surgery.


-- >> Company has HUD approval, not HDE yet.

From 21 Jul 8-K:

During Phase III-level multi-center studies, HUD marketing of PermaDerm™ can begin. Marketing of PermaDerm™ under HUD designation will facilitate clinical experience with the product, and expedite full market penetration after completion of a PMA or PDP. The HUD designation has already been received and, upon completion of the Lonza Transaction, will be transferred to us as part of a licensing agreement with the University of Cincinnati, which will allow immediate manufacture and sale of PermaDerm™ for treatment of catastrophic burns. Subsequent to the transfer of the HUD designation, a Humanitarian Device Exemption (HDE) application must be submitted to specify the protocol for clinical use of the HUD. We have commenced preparation of the HDE application and we expect to file it with the FDA by the end of this year. FDA is permitted 6 months for review of HDE applications. After approval of the HDE, sales of the HUD can begin. HDEs are reviewed as PMAs that are not required to demonstrate evidence of efficacy. Each hospital that uses the HUD must activate study protocol (which must be reviewed and approved by a local Institutional Review Board (IRB)) to monitor risks and possible adverse reactions. We will develop a standard study protocol, and act as liaison to activate the protocol at each hospital.
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