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Brazilian Government Grants Approval of the HairMax LaserCombR as a Home-Use Laser Medical Device to Promote Hair Growth and Treat Hair Loss
September 2, 2008 ¡V Boca Raton, FL - Lexington International, LLC, manufacturer and developer of advanced medical laser devices to treat hair loss, has obtained approval from Brazil's ANVISA for the HairMax LaserCombR as a medical device to promote hair growth and treat hair loss in men and women.
The approval was based on extensive clinical studies on men and women suffering from the most common form of hair loss. The study concluded that 93% of the participants using the HairMax LaserCombR experienced hair regrowth. The average number of hairs per square centimeter increased by 19 hairs/cm2 over a six-month period. During the study, there were no reports of serious or adverse side effects.
Lexington has partnered with Spa do Brasil as the exclusive distributor of Lexington products in Brazil. Spa do Brasil was instrumental in working through the ANVISA process and will be making the HairMax LaserCombR available as an at-home treatment to those suffering from hair loss in Brazil.
Expressing Lexington's marketing direction, David Michaels, Managing Director of Lexington states; ¡§Brazil is a major milestone in our marketing plan to gain worldwide acceptance of the HairMax LaserCombR. Achieving ANVISA approval enables Lexington to expand into the Brazilian market and provide our innovative solution to those suffering from the emotional strain of hair loss. We will continue our quest to conquer hair loss around the globe by pursuing additional international medical device registrations and further establish the credibility of the HairMax LaserCombR in the global marketplace¡¨.
Through Lexington's ongoing commitment to clinical research and development, the HairMax LaserCombR has achieved medical device clearance by the US FDA, Health Canada, Singapore Health Authority, Israeli Ministry of Health, Russian Federation of Health, and the Korean FDA.
With the advent of approval by ANVISA for the HairMax LaserCombR, Brazilians now have a new drug free modality to grow thicker, healthier, and fuller hair in the privacy and convenience of their home.
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