Brazilian Government Grants
Approval of the HairMax LaserComb® as a Home-Use Laser Medical
Device to Promote Hair Growth and Treat Hair Loss
September 2, 2008 –
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 LaserComb® 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 LaserComb®
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 LaserComb® 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 LaserComb®.
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 LaserComb® in the global
marketplace”.
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, and the
Korean FDA.
With the advent of approval by ANVISA for the HairMax LaserComb®,
Brazilians now have a new drug free modality to grow thicker,
healthier, and fuller hair in the privacy and convenience of their
home.
For more information, please visit http://www.hairmax.com/advisoryboard/
About Lexington International, LLC
Based in Boca Raton, Florida, Lexington International, LLC
manufactures and distributes the HairMax LaserComb to 89 countries
worldwide. The HairMax has been on the market since 2001 and, in
January 2007, became the first and only medical device cleared by
the FDA to “Promote Hair Growth” in men suffering from certain
classes of Androgenetic Alopecia.
Grounded in over 20 years of international research and studies, the
HairMax is recognized as the leader in emerging technologies to
treat hair loss. Lexington is a proud member of the Better Business
Bureau, “Team Florida,” and has received the “Commercial and Export
Achievement” award from the US Department of Commerce
