HairMax LaserComb Receives Approval by the Indonesian Ministry of Health
Posted by Fran Dubsky
Press Release (PDF)

Lexington Int’l announces approval by the Indonesian Ministry of Health for the HairMax LaserComb as a home-use laser phototherapy medical device for the treatment of hair loss and the promotion of hair growth.

Aug. 22, 2013 - BOCA RATON, Fla. -- Boca Raton, FL - Lexington International, LLC, is the developer and manufacturer of the HairMax LaserComb® laser phototherapy medical device, for the treatment of hereditary hair loss in men and women. The HairMax LaserComb incorporates a patented hair parting teeth mechanism which assures optimal delivery of laser energy to the hair follicles. Further, the HairMax is the only home use laser phototherapy device proven safe and effective in 7 clinical trials with 460 subjects and has US FDA marketing clearance for the treatment of hereditary hair loss. The Indonesian Ministry of Health granted approval to market the three models of the device, the HairMax Advanced 7, HairMax Lux 9, and HairMax Professional 12. Indonesia is the most populous country in Southeast Asia with the largest economy. The rapidly growing hair care market (which includes products for hair loss) in Indonesia had total revenue of approximately USD500 million in 2012 according to Datamonitor, and is forecasted to grow at over 7.5% a year through 2017. This makes Indonesia an ideal market opportunity for the HairMax LaserComb.

With this approval, Indonesians now have a new and effective non-drug treatment option to treat their hair loss in the privacy and convenience of their home. 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 (pattern hair loss). The results of these studies showed a statistically significant increase in average hair growth of subjects on the HairMax LaserComb vs. those on the control device. The studies also demonstrated that 93% of the subjects using the HairMax LaserComb experienced hair regrowth. During the study, no serious or adverse side effects occurred.

David Michaels, Managing Director of Lexington states; “Southeast Asia is an important market for the HairMax LaserComb as it demonstrating extraordinary growth. Gaining approval in Indonesia, the largest country in that region, is a major step forward in our marketing efforts .This approval now enables the HairMax to reach a significantly larger audience of people suffering from hair loss in that part of the world”.

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, FL, Lexington is a manufacturer and developer of advanced phototherapy medical devices for home use. The HairMax LaserComb is the first and only device of its kind with FDA Clearance for marketing. Over the past 12 years and in over 165 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals to treat their hair condition.

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