This Press Release was just released on the results of the recent clinical studies of the HairMax in males and the subsequent FDA Clearance for marketing of 3 new devices.

April 21, 2011, Boca Raton, FL – 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 square, 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.

LAS

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