For Immediate Release
FDA Clears the HairMax LaserComb for the Promotion of Hair Growth
ActiveForever Becomes Authorized Dealer for Lexington International's New FDA Approved Hair Growth Product
BOCA RATON, FL - February 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 LaserCombÂ®. 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, now clinically proven to promote hair growth in males with androgenetic alopecia (Norwood IIA to V with Fitzpatrick skin types I to IV).
To view the FDA's public record of this clearance visit www.fda.gov/cdrh/pdf6/K060305.pdf .
This FDA clearance of the HairMax LaserComb offers an exciting new modality for the promotion of hair growth in males. Until now, the FDA has only approved two other products as solutions to combat hair loss, a condition that affects approximately 55 million men in the U.S. But the HairMax LaserComb stands out as the only proven drug-free alternative. This gives many hair loss sufferers, previously unable or unwilling to turn to drug-based solutions, newfound hope in their battle. Fortunately, treatments using the HairMax LaserComb are easy to administer, only ten to fifteen minutes three times per week, and the laser device is convenient to use in the comfort and privacy of your own home.
For the FDA submission, Lexington conducted an extensive clinical study in four different locations across 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 by19 hairs/cmÂ² 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 they will be submitting the data to the FDA shortly. David Michaels, Managing Director, shares his thoughts on this momentous announcement, "We are very excited that we have reached a major milestone in hair care and science. Laser hair therapy is the talk of the hair restoration industry today. And not only were the results of this study extremely significant, but with the credibility of the FDA clearance, we are soundly positioned to make a substantial impact in the emerging hair restoration industry."
Dr. Matt Leavitt, Chief Medical Advisor to Lexington, expresses his enthusiasm on news of the FDA clearance, "The HairMax LaserComb is a method of treatment that can be of great help to men of all ages suffering from hair loss. I am impressed with the protocol and results from the clinical trials that Lexington has conducted. With the FDA clearing the HairMax LaserComb as a medical device, it offers an attractive option for hair growth for medical practitioners. We can now deliver a new modality to our patients and achieve strong user satisfaction."
To purchase the product from a National Authorized Dealer, contact www.ActiveForever.com, 1-800-377-8033 or e-mail Care@ActiveForever.com.
Established in 1993, now one of the highest ranked web businesses in the country, ActiveForever offers the convenience of one-stop shopping for more than 10,000 competitively priced, life-enhancing products that address almost all physical and clinical needs. Products include aids for daily living, bath, safety and hygiene products, mobility aids, durable medical equipment, low vision aids, ergonomic products, pain relief and land/aqua exercise therapy products. ActiveForever also provides a multitude of product solutions for arthritis, Parkinson's disease, diabetes, stroke rehabilitation, low vision, hearing loss, sports injuries and other physically limiting conditions. The company also offers unique gift ideas, free print catalogs and two interactive retail stores. For more information, visit www.ActiveForever.com or call 1.800.377.8033.
About Lexington International, LLC The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Both the press and users alike have universally taken to the HairMax LaserComb. Coverage has included Dateline NBC, TIME Magazine, as one of their "Inventions of the Year", as well as the November 2004 issue of Good Housekeeping Magazine. Lexington is an ISO 9001 & 13485 Quality Assured laser manufacturer. We follow GMP (Good Manufacturing Practices) of a medical device manufacturer. Clinical studies closely adhered to GCP (Good Clinical Practices) with a protocols and case report forms reviewed by an IRB (Ethics Committee). Lexington is also a member in good standing of the Better Business Bureau.