Hereditary hair loss is a
devastating condition affecting over 30 million women in the United
States. Until recently, when the HairMax Lux 9 was initially FDA
Cleared for marketing for treatment of females, there had been only
one FDA approved drug for treating this condition in women. This
latest FDA Clearance now expands the HairMax treatment options for
the three of the HairMax LaserComb models, as an effective
first-line treatment of hereditary hair loss in both men and women.
This is the fourth FDA 510(k) Clearance for marketing granted to
Lexington Int’l this year.
The HairMax LaserComb cordless models that are now available are the
HairMax Advanced 7, the HairMax Lux 9, and the HairMax Professional
12. These devices are offered at varying price points which fit the
needs of all people wishing to treat their hair loss condition. The
HairMax is easy and convenient to use with treatments at home of
just 9-15 minutes per day, three times per week to achieve results,
which can be seen in as little as 12 weeks. Also, the HairMax is
safe to use, as no serious side effects have ever been reported from
use of the HairMax.
This FDA marketing Clearance for females combined with prior FDA
marketing Clearance for males, provides the following official
indication for the HairMax LaserComb.
The HairMax Advanced 7, Lux9, and the Professional 12 models are
indicated to treat Androgenetic Alopecia, and promote hair growth in
males who have Norwood Hamilton Classifications of IIa to V and in
females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns
of hair loss and who both have Fitzpatrick Skin Types I to IV.
This latest milestone is the culmination of Lexington’s goal to
offer a complete line of innovative, cutting edge, phototherapy
devices for treating hereditary hair loss in men and women around
the world. These testimonials from satisfied users of the HairMax
are typical of the numerous comments we have received: “It got to
the point that I wasn’t going out much anymore. I noticed that when
I spoke to my relatives and friends they weren’t looking directly at
me – they were looking at my hairline and that made me feel even
more self-conscious about my hair loss.” And, “HairMax has
rejuvenated my hair growth, my self-esteem and my confidence”.
In four double-blind clinical studies on the treatment of
androgenetic alopecia (hereditary hair loss) in both men and women
over 93% of subjects in the HairMax LaserComb groups experienced
hair growth at 6 months. These results were consistent in all
studies showing that the results with the HairMax are reproducible
and predictable. Since 2001, Lexington has completed a total of
seven clinical studies with 460 subjects. All of the studies
(including these four), have conclusively proven that the HairMax
LaserComb family of products are efficacious and safe as first line
therapy for appropriate classes of hereditary hair loss.
Mr. David Michaels, Managing Director of Lexington said, “We have
spent 11 years of R&D, innovation, and the completion of seven
clinical studies to bring these innovative products to market. This
recent FDA marketing Clearance brings to fruition our goal of
offering a complete line of laser phototherapy products for people
who are suffering from hereditary hair loss. Our challenge now is
not how to get there, but how to assure that we get this information
about the HairMax out to the millions of people suffering from this
devastating condition”.
Randy Veliky, Lexington COO said: “This recent FDA Clearance means
that the HairMax LaserComb with its patented technology and state of
the art design, now solidifies the position of Lexington as the
world-wide leader in the treatment of hair loss. No other company
marketing a device of its kind for hair loss matches the breadth,
scope, and depth of our product line.”
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