BOCA RATON, Fla., April 21, 2011 /PRNewswire/ -- Lexington International, LLC is pleased to announce that it has successfully completed 2 clinical studies of the HairMax LaserComb proving the efficacy and safety of 3 new devices for the treatment of androgenetic alopecia (hereditary hair loss). The analysis showed that 95.4% of participants using the HairMax LaserComb experienced hair growth. Furthermore, the average increases in hair count for participants in the HairMax LaserComb group was 20.4 hairs per centimeter squared, which is considered medically and scientifically significant. None of the participants in the studies experienced any serious side effects. Based in part on submission of clinical results, the FDA Granted Class II Clearance 510(k) K103368 of these medical devices for sale in the USA for the 'Treatment of Hair Loss and Promotion of Hair Growth' in males.
The two double-blind, device-controlled multi-center studies were conducted by Zoe Draelos, MD, David Goldberg, MD, Michael Jarrett, MD, and Abe Mercadis, MD, under GCP (Good Clinical Practice) guidelines and IRB (Institutional Review Board) approval. These clinical trials are posted on www.clinicaltrials.gov. Submission of these data was a major component of the FDA filing and was a key factor in the agency's decision to clear the HairMax LaserComb. The FDA 510(k) Clearance further validates the HairMax as a non-drug option for treating hereditary hair loss in males.
The FDA indication of use for the new models is as follows:
"The HairMax LaserComb® is indicated to treat androgenetic alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV."
Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects and all of the studies have demonstrated the efficacy and safety of the HairMax LaserComb. These statistically significant clinical study results validate the fact that the HairMax should be considered as a first line treatment for appropriate people suffering from hereditary hair loss.
Mr. David Michaels, Managing Director said, "Hair growth studies are challenging to conduct as they require shaving an area of the scalp and placing a tattoo marker for hair counts through macrophotography. Ultimately, we were successful in demonstrating hair growth through Phototrichogram analysis. There is clear evidence of hair miniaturization reversal, revival of dormant hairs and an increased number of hairs in a follicular unit. We clearly proved that the HairMax LaserComb is an effective treatment for androgenetic alopecia in males. Moving forward, we have a very active clinical agenda, including mechanistic studies and additional indications."
The three new models now available are the HairMax Advanced 7 (7 lasers), the HairMax Lux 9 (9 lasers), and the HairMax Professional 12 (12 lasers). The number of lasers contained in each model determines the treatment time required during each session. The availability of these three new models, at different price points, offers the benefits of this exciting treatment to a larger audience, including retail. The New HairMax models feature a sleek, modern design and are now battery powered. Users no longer have to be tethered to a wall outlet, offering complete freedom of movement when using the device.
"The new devices, which are designed for mass market appeal, will greatly expand the treatment options for people suffering from thinning hair," said Randy Veliky, Lexington COO. "The combination of our patented technology, state of the art design and the proven efficacy will better satisfy the needs of the millions of men suffering from this condition"
About Lexington International, LLC:
Based in Boca Raton, Lexington is a manufacturer and developer of advanced phototherapy devices for home use. Lexington International markets the only laser device that has published the results of the efficacy of the device in a peer review journal. The HairMax is also the first and only device of its kind with FDA Clearance for marketing. Over the past 10 years and in over 155 countries worldwide, Lexington Int., LLC has helped hundreds of thousands of individuals to treat their hair condition. Contact us at: [email protected]. (www.hairmax.com)
SOURCE Lexington International, LLC