Only the third product to be appproved to treat scalp hair loss after Propecia (pill) and Rogaine (topical).
Now when will we see that home laser thingy for hair removal in stores?
http://www.hairmaxforum.com/forum/showthread.php?p=11522#post11522
BOCA RATON, FL, January, 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, clinically proven to promote hair growth in males with androgenetic alopecia (Norwood II A to V with Fitzpatrick skin types I to IV).
For the FDA submission, Lexington conducted an extensive clinical study in four different locations around 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/cm² over a six-month period. During the study, there were not any 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 demonstrating the efficacy of the HairMax LaserComb in females is concluding and we will be submitting the data to the FDA shortly.
David Michaels, Managing Director, shares his thoughts on this momentous announcement, “I believe the results of this study are far more significant than any other product on the market today. We are very excited about having reached a major milestone in hair care and science. Laser hair therapy is the talk of the hair restoration industry and with our FDA clearance behind us, we are now soundly positioned to dominate this emerging Laser treatment segment.”
It is estimated that 55 million men are suffering from hair loss in the United States alone. Until recently, the FDA has only approved two other products as solutions to combat hair loss. The clearance of the HairMax LaserComb offers an exciting new modality for the stimulation of hair growth in males. Compliance is a key factor in the efficacy of any hair growth treatment. Fortunately, The HairMax LaserComb is very easy to use in the comfort and convenience of your own home, treatments last 10 to 15 minutes three times per week. The HairMax LaserComb is also the only drug-free option available thus allowing many who were previously unable or weary of drug based solutions new found hope in their battle against hair loss.
Dr. Matt Leavitt, Chief Medical Advisor to Lexington, expresses his enthusiasm on news of the 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, comments, “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. Extensive research has also allowed Lexington to determine the optimal wavelength and energy level 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
Based in Boca Raton, Florida Lexington International manufactures and distributes the HairMax LaserComb® (www.hairmax.com) 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.