May 21, 2012
-- Boca Raton, FL - Lexington International, LLC, developer and manufacturer of the HairMax LaserComb® is pleased to announce that the HairMax LaserComb has been approved by the Thailand FDA to market the HairMax Advanced 7, the Lux 9, and the Professional 12 devices in that country. Men and women of Thailand afflicted with hair loss, now have a new and effective non-drug treatment option to treat their condition in the privacy and convenience of their home. The HairMax is the only laser phototherapy device proven effective the treatment of certain classes of hereditary hair loss in both males and females and is USA FDA Class 2 Cleared for marketing.
The approval was based on results of major clinical studies of men and women suffering from the most common form of hair loss, Androgenetic Alopecia otherwise known as pattern hair loss. The results of these studies showed a statistically significant increase in mean terminal hair density of subjects on the HairMax LaserComb vs. those on the control device. The study also found that 93% of the subjects using the HairMax LaserComb experienced hair regrowth. During the study, no serious or adverse side effects occurred.
A study was conducted in 2002 Bangkok, Thailand on the prevalence of hair loss. The conclusion of the study was that: “the prevalence of cosmetically significant pattern baldness was 38.5%”. Based on the population of Thailand, this prevalence means that there are about 15 million men and women experiencing significant hair loss. This represents an excellent opportunity for sales of the HairMax LaserComb in that country
David Michaels, Managing Director of Lexington states; “The introduction of the HairMax in Thailand represents a significant opportunity, and is one more step in our marketing efforts to place the HairMax LaserComb in all world-wide markets.” Mr. Michaels further stated, “Lexington will continue to pursue additional international medical device registrations to assure further availability of the HairMax LaserComb to the millions of people suffering from hair loss around the world.”
About Lexington International, LLC
Based in Boca Raton, Lexington International is a manufacturer and developer of advanced medical laser devices to treat hair loss and scalp disorders. Lexington International markets the only laser phototherapy device which has published results of clinical trial proving efficacy and safety in a peer review journal. The company, was one of just 14 leading manufacturing exporting companies nationwide to receive the 2009 U.S. President’s “E” Award, which recognizes successes in world markets and subsequent contributions to the U.S. economy. Over the past 8 years and in over 163 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals to treat their hair condition and enrich their lives.. (www.hairmax.com)