TORONTO, ONTARIO--(Marketwired - Apr 11, 2013) - Biologix Hair Inc. (BLGX) (BLGX) announces that the initial clinician licensing numbers reported in a February 6, 2013 press release were significantly understated for the period ending January 31, 2013.
The number of contracting clinics which have reserved certain exclusive purchase and treatment rights for the Biologix Hair Therapy System™ and to be licensed as certified Biologix Hair Therapy Centers™ remains unchanged at 121; the number of countries in which the clinics are located remains as originally reported, six.
The upward revisions are related to the number of existing patients represented by the 121 contracting clinics and those patients likely to seek the Biologix hair loss prevention or hair regeneration therapies, as reported on a clinic-by-clinic basis. The initial report was based on data reflecting the number of unique patients treated by each clinic over the previous twelve-month period. However, after extensive discussions with clinicians, Biologix has revised its data gathering and reporting to reflect the number of unique patients treated by each contracting clinic over the previous five-year period.
The previously reported number of unique patients represented by the 121 contracting clinics has been revised upward from 372,440 to 695,365 - expanding the contracted Biologix patient universe by 322,925 patients.
The previously reported number of patients estimated on a clinic-by-clinic basis that would be interested in either the Biologix hair loss prevention or hair regeneration treatments and are likely candidates for the Biologix Hair Therapy System™ has been revised upwards from 205,919 to 244,131 patients.
Ron Holland, Biologix Director and CEO, stated, "It became evident after extensive communication with literally thousands of clinicians around the world that they consider their 'active' patient base to be comprised of people treated during the past five years - not twelve months.
"Subsequently, we have modified the time period of data relevance from one year to five and standardized our clinician licensing documentation accordingly. I thank Donna Lieder, Vice President of Clinician Licensing, and the rest of her team for their diligent efforts in ascertaining updated information for the period ending January 31, 2013."
About Biologix Hair Inc. and Biologix Hair Science Ltd.
Biologix Hair Inc. (Biologix Hair), together with its wholly owned biotechnology subsidiary, Biologix Hair Science Ltd. ™ (BHS), is focused on realizing the full market potential for its patent-pending hair loss formula - Biologix Revive - and its demonstrated ability to prevent and reverse the effects of alopecia, which plagues hundreds of millions worldwide.
Between mid-2004 and mid-2012, more than 30,000 pre-clinical-trial treatments of Biologix Revive were administered to 5,000-plus patients in South America suffering with varying degrees of alopecia, as well as people seeking preventive treatment. The participating treatment clinicians subjectively observed and reported that virtually 100% of preventive care clients continued to retain their healthy hair and an estimated 80-85% of the males and 90-plus% of the females treated for hair regeneration experienced significant regrowth of their own natural hair. And among alopecia areata patients, virtually total hair regrowth was observed in 100% of the cases. To date, no negative side effects have been reported.
BHS is currently focused on obtaining FDA approval for its breakthrough hair loss prevention and regeneration therapy and has initiated a research and development program with one of the world's leading medical research universities, the Beijing Institute of Technology (BIT). The R&D program, expected to take approximately twelve months to complete, is an important final step before formal clinical trials and the FDA approval process begins.
Additionally, on May 11, 2012, Venable LLC, the Washington-based law firm overseeing the worldwide IP and regulatory approval processes on behalf of BHS, filed a Patent Cooperation Treaty (PCT) application on behalf of BHS for Biologix Revive in Geneva, Switzerland. The PCT is an international treaty, administered by the World Intellectual Property Organization (WIPO), to which 144 countries have as of now contracted, including Canada and the United States.
Biologix management is determined to be in a ready position to capitalize on the high-margin sales potential of the Biologix Hair Therapy System™, if and when FDA and other major market approvals are forthcoming.
As BHS advances the regulatory approval process, Biologix Hair, together with wholly owned subsidiary companies operated by BHS, are rapidly developing a global distribution network of licensed clinicians and medical practitioners seeking to become Certified Biologix Hair Therapists™ and secure exclusive territorial purchasing and treatment rights for the Biologix Hair Therapy System™.
Biologix Hair has decided not to risk creating any potential regulatory conflicts by offering treatment outside the United States and other major high-product-margin markets until FDA approval has been granted. Therefore, the Biologix Hair Therapy System™ is not yet available other than to the 5,000+ patients who participated in the pre-clinical-trials conducted in South America.
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This announcement is not an offer to sell any Biologix Hair Inc. ("Biologix") securities. Offers for any given security are made only through applicable offering circulars and related documents filed with the SEC pursuant to the Securities Act of 1933 or the Securities Exchange Act of 1934. Certain statements contained herein and subsequent oral statements made by and on behalf of Biologix may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and includes, without limitation, the development of treatment centers and approval from regulatory authorities. Forward-looking statements express our expectations or predictions of future events or results. They are not guarantees and are subject to many risks and uncertainties. There are a number of factors beyond our control that could cause actual events or results to be significantly different from those described in the forward-looking statements. Any or all of our forward-looking statements in this report or in any other public statements we make may turn out to be wrong. We undertake no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise. In Canada, Europe and the United States, the Biologix treatment is not approved for use by Health Canada, EMA or the FDA. The company makes no representations that it will receive Health Canada, EMA or FDA approvals.