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.”.........
... icic
