Lexington International, LLC Gains Australia TGA Clearance of the HairMax LaserComb for the Treatment of Hereditary Hair Loss in Both Men and Women

Australian Therapeutic Goods Administration (TGA) Clearance Expands Lexington International, LLC's International Market for the HairMax LaserComb.

Boca Raton, FL June 1, 2009 -- Lexington International is pleased to announce that the Australian TGA has granted regulatory clearance for the HairMax LaserComb for the treatment of certain classes of Androgenetic Alopecia (AGA), or pattern baldness in both males and females. Lexington submitted clinical data from male and female studies, along with ISO and GMP accreditations to achieve this approval. The HairMax LaserComb is the only Laser PhotoTherapy medical device clinically proven to grow hair in the most common classes of hereditary hair loss.

A large percentage of the population in Australia is afflicted with AGA.  In a study published in 2005 in the Journal of Investigative Dermatology, it was estimated that there are over 12 million Australian men and women with AGA. Lexington International has invested substantial resources in conducting clinical studies to demonstrate the effectiveness of the HairMax in treating AGA and gain international acceptance from governments, medical experts, and consumers. Approval of the HairMax LaserComb in Australia adds to an already large portfolio of medical device approvals and patents held by Lexington International worldwide. 

With this clearance by the Australian TGA for the HairMax LaserComb, Australians now have a new drug free modality to treat their hair loss and re-grow thicker, healthier, and fuller hair in the privacy and convenience of their home.

Co-founder and Managing Director of Lexington International, LLC, Mr. David Michaels believes that this approval by the TGA represents a milestone for the company and said, "The Australian TGA clearance holds special meaning for Lexington. The HairMax LaserComb originated in Sydney and we are excited about the opportunity to help those suffering from hair loss in Australia. Once again, this clearance represents Lexington's ongoing commitment to gaining worldwide marketing approval and to continue our efforts to be the leading choice for all men and women experiencing hereditary hair loss".

Through Lexington's ongoing commitment to clinical research and development, the HairMax LaserComb has achieved medical device clearance by the US FDA, Health Canada, Singapore Health Authority, Israeli Ministry of Health, Russian Federation of Health, Korean FDA and Brazilian ANVISA.

The clinical study proving the efficacy of the HairMax LaserComb was recently published in the peer-review journal Clinical Drug Investigation, May 2009.  This clinical study was pivotal in the US FDA 510(k) submission and subsequent clearance of the HairMax LaserComb for marketing in the US.  With no reports of serious side effects, and an incomparable satisfaction rate, the LaserComb is revolutionizing the hair care industry. The HairMax is a breakthrough in hair growth, hair care and hair science.

The HairMax LaserComb is the first and only hand-held Laser PhotoTherapy device cleared for marketing by the FDA.

About Lexington International, LLC

The HairMax LaserComb was invented in Australia.  Lexington is based in Boca Raton, Fla., Lexington International manufactures and distributes the HairMax LaserComb to more than 90 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Laser PhotoTherapy

Both the press and users alike have universally taken to the HairMax LaserComb. Coverage has included Dateline NBC, TIME Magazine, as one of their "Inventions of the Year", as well as the November 2004 issue of Good Housekeeping Magazine. Lexington is a proud member of "Team Florida" and has participated in high-level, overseas trade missions with Governor Jeb Bush. Additionally, the company was awarded by the U.S. Department of Commerce for "Commercial and Export Achievement."

Lexington International, LLC
Attention: Media Relations
mediarelations @ hairmax.com