BOCA RATON, FL- A hand held laser is in trials to potentially become the first device ever cleared by the
Food and Drug Administration to state that it is proven to regrow hair and prevent hairloss in both men and women. The announcement was made August 11th by Lexington International LLC, manufacturer of the HairMax LaserComb, the only hand-held laser designed for hair.
Approval of the device would make the HairMax LaserComb only the third product ever given such approval or market
clearance, according to David Michaels, managing director of Boca Raton-based Lexington International. The HairMax LaserComb already complies with FDA safety requirements as a cosmetic laser.
“The significance of this is so important because while a host of hair products claim to be safe and effective, only two have been granted the ability to say that their products have been clinically proven to halt hairloss and regrow hair,” said Michaels.
“Moreover the HairMax LaserComb enhances the results of hair transplants,” stated Michaels. “We are confident that it will soon become an essential tool for hair transplant surgeons”.
Lexington is optimistic that their LaserComb will join Minoxidil as the only product approved or cleared for both men and women, and believes its success rate will exceed that of Rogaine. Minoxidil, the active ingredient in Rogaine for men and women, has shown a success rate of 19% for moderate hair growth and 40% for minimal hair growth, according to their packaging for women.
Clinical trials began on the LaserComb in April and the company has now passed the very important three-month mark. “Although the clinical trials will last 12 months, the three- and four-month marks are significant milestones for monitoring results,” according to Dr. Martin Unger, Past President of the American Society of Hair Restoration Surgery and one of the worlds leading authorities in hair research.
According to Michaels, anecdotal evidence Lexington has collected to date suggests that more than 90% of users achieve some positive benefits and results.
“In addition, the LaserComb has no adverse side effects, what-so-ever,” says Michaels. “The same can’t be said for topical applications, which may sometimes result in an itching, red, inflamed or painful scalp.
Because the HairMax LaserComb is not a hormone-related medication like Propecia, it is safe for women. And when used properly, women who use HairMax LaserComb do not run the risk of experiencing unwanted hair growth on the face or body, as is possible with minoxidil-based solutions.
The HairMax LaserComb, which was named one of TIME Magazine’s “Inventions of the Year” for 2001, is a Low Level Laser Therapy (LLLT) device also referred to as a Cold Laser. International studies have shown that Low Level Laser Therapy works by the principals of PhotoBioStimulation in which certain wavelengths of light in a directed beam increase the ATP (energy) of the cell at the molecular level. The laser energy may also increase blood and lymph circulation in the tissue. When a person is in the process of losing his or her hair, the follicles haven’t necessarily died yet – they are just weak and have become dormant. The LaserComb’s light energy revives the resting follicles, as well as bolsters those that are still functioning healthily. “This is not the laser you saw in ‘Star Wars,'” notes Michaels. “It’s safe, effective biostimulative light.”
The trials should be completed and the results submitted to the FDA in the early spring. The FDA has already cleared two other LLLT devices this year for “carpel tunnel syndrome” and for “chronic pain relief.”
The trials are being done concurrently on both men and women with independent medical doctors under specifications that the FDA has been notified of. Each subject will use the comb for six months and submit to monthly hair counts to assess hair growth and hair mass.
Lexington International had its beginnings in Sydney, Australia as a hair restoration laser clinic where a prototype of the LaserComb was developed. The company moved to Boca Raton on Florida’s Internet Coast in 2000. In 2001, it introduced the HairMax LaserComb internationally, receiving considerable public attention.
Edited from a press release from Lexington International.