The approval was based on a submission of results from a major clinical study of men and women suffering from the most common form of hair loss, Androgenetic Alopecia. The study results showed a statistically significant increase in hair growth of subjects using the HairMax LaserComb vs. those on the control device. Results from these studies showed that 93% of the subjects using the HairMax LaserComb experienced hair regrowth. No incidences of serious side effects occurred during any of the clinical trials, nor from field use of the device since it was launched in 2001.
According to Euromarkets, the Hair Care market segment in the Colombia is valued at over US$425 million of which a large portion are for products to treat hair loss. This makes Colombia an ideal and significant market opportunity for the HairMax LaserComb.
David Michaels, Managing Director of Lexington said; “The introduction of the HairMax in Colombia continues our ongoing marketing efforts to expand distribution of the device in South America. Achieving the approval of INVIMA enables us to reach a wider audience of people suffering from hair loss in that region”. Mr. Michaels stated, “Lexington will continue to pursue additional international medical device registrations to assure further availability of the HairMax LaserComb to help enrich the lives of 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 cleared for marketing by the FDA to promote hair growth in men and women suffering from certain classes of hereditary hair loss. 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 11 years and in over 165 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals to treat their hair condition. (www.hairmax.com)