For Immediate Release
FDA CLEARS THE HAIRMAX LASERCOMB FOR THE PROMOTION OF HAIR GROWTH
BOCA RATON, FL, February 2007 Lexington International
LLC is proud to announce the landmark achievement
of US Food & Drug Administration (FDA) clearance
for their medical laser device, the HairMax
LaserComb. Through years of extensive research
and clinical studies in the science of hair
growth, Lexington has developed an affordable
and convenient, hand-held laser device, now
clinically proven to promote hair growth in
males with androgenetic alopecia (Norwood IIA
to V with Fitzpatrick skin types I to IV).
To view FDA's public record of this clearance
visit
www.fda.gov/cdrh/pdf6/K060305.pdf.
This FDA clearance of the HairMax LaserComb offers an exciting new modality for the promotion of hair growth in males. Until now, the FDA has only approved two other products as solutions to combat hair loss, a condition that affects approximately 55 million men in the U.S. But the HairMax LaserComb stands out as the only proven drug-free alternative. This gives many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle. Fortunately, treatments using the HairMax LaserComb are easy to administer, only 10 to 15 minutes three times per week, and the laser device is convenient to use in the comfort and privacy of your own home.
For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm� over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.
Lexington's clinical study investigating the
efficacy of the HairMax LaserComb in females
is concluding and they will be submitting the
data to the FDA shortly.
David Michaels, Managing Director, shares his
thoughts on this momentous announcement, "We
are very excited that we have reached a major
milestone in hair care and science. Laser
hair therapy is the talk of the hair restoration
industry today. And not only were the
results of this study extremely significant,
but with the credibility of the FDA clearance,
we are soundly positioned to make a substantial
impact in the emerging hair restoration industry."


Dr.
Matt Leavitt, Chief Medical Advisor to Lexington,
expresses his enthusiasm on news of the FDA
clearance, "The HairMax LaserComb is a
method of treatment that can be of great help
to men of all ages suffering from hair loss.
I am impressed with the protocol and results
from the clinical trials that Lexington has
conducted. With the FDA clearing the HairMax
LaserComb as a medical device, it offers an
attractive option for hair growth for medical
practitioners. We can now deliver a new modality
to our patients and achieve strong user satisfaction."
Randy Veliky, Lexington COO, concludes, "The
HairMax LaserComb will revolutionize the hair
growth industry, but we are not stopping there.
Lexington is dedicated to continuing research
into laser technology. We will be expanding
our offering of laser hair growth solutions
to include freestanding clinical units, affordable
laser panel arrays for the home market and broadening
the features of our current products."
For over 20 years, the directors of Lexington
have been at the forefront of laser hair growth
research. Born from this passion for innovation,
The HairMax LaserComb uses a patented technology
to part the hair allowing the focused laser
energy to reach the scalp. The laser is most
effective when it has an unobstructed path directly
to the hair follicle. Through extensive research,
Lexington has determined the optimal wavelength
and energy level needed to deliver maximum results.
Lexington's continued dedication to consistent
innovation ensures that users are always receiving
the latest in laser hair technology.
About Lexington International, LLC
Originating in Sydney Australia and now based
in Boca Raton Florida, Lexington manufactures
and distributes the HairMax LaserComb to more
than 80 countries and has provided new hope
and satisfaction to tens of thousands of customers
since 2001. The HairMax LaserComb is based
on 20 years of international research and studies
on the effects of Low Level Laser use.
Both the press and users alike have universally
taken to the HairMax LaserComb. Coverage
has included Dateline NBC, TIME Magazine,
as one of their Inventions of the Year, as well
as the November 2004 issue of Good Housekeeping
Magazine.
Lexington is an ISO 9001 & 13485 Quality Assured laser manufacturer. We follow GMP (Good Manufacturing Practices) of a medical device manufacturer. Clinical studies closely adhered to GCP (Good Clinical Practices) with a protocols and case report forms reviewed by an IRB (Ethics Committee). Lexington is also a member in good standing of the Better Business Bureau.
Lexington is a proud participant of Team Floridaand
has participated in high-level, overseas trade
missions with Governor Jeb Bush. Additionally,
the company was awarded by the U.S. Department
of Commerce for Commercial and Export Achievement.