February 19, 2007, Boca Raton, FL--The U.S. Food and Drug Administration has granted marketing clearance to Lexington International for the company's HairMax LaserComb, a handheld diode-laser device designed to promote hair growth in males with androgenetic alopecia.
According to the company, the FDA has approved two other products as solutions to combat hair loss, but the HairMax LaserComb is the only drug-free alternative. The company says that treatments using the HairMax LaserComb are easy to administer, taking only 10 to 15 minutes three times per week. In addition, the laser device is designed for use by the consumer at home.
For the FDA submission, Lexington conducted a clinical study in four different locations in 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 no 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 investigating the efficacy of the HairMax LaserComb in females is concluding and the company plans to submit the data to the FDA shortly.
"The HairMax LaserComb will revolutionize the hair growth industry, but we are not stopping there," said Randy Veliky, Lexington COO. "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."