For Immediate Release
CLEARED FOR PREVENTION OF HAIR LOSS AND STIMULATION OF HAIR REGROWTH IN
MEN AND WOMEN
BOCA RATON, FL, January 14, 2003 – The HairMax LaserComb, A Low Level Laser Device for hair received certification by the Canadian Government as a Class 2 Medical Device for claims and indications to strengthen hair, prevent hair loss, and stimulate regrowth of scalp hair in men and women.
The HairMax LaserComb, manufactured by Lexington International LLC, is a breakthrough personal device for delivering the healthy, nourishing effects of Low Level Laser Therapy (LLLT) to hair. LLLT uses the stimulating effects of laser light in the natural, scientific process known as PhotoBioStimulation to also improve the quality and thickness of hair.
Based on appropriate scientific information and clinical data submitted to Health Canada, and after examination of all data submitted, Medical Device License Number 61237 was granted to Lexington International allowing the following therapeutic claims to be made to the Canadian public.
“This is significant news and a medical milestone as the HairMax LaserComb is the first ever medical device for home use approved by any government to combat hair loss, especially for both men and women”, according to David Michaels, Managing Director of Lexington International LLC. “HairMax LaserComb is now officially qualified in Canada as an effective and attractive alternative to both topical and oral drug therapies.”
The HairMax LaserComb has been undergoing Clinical Trials throughout 2002. Clinical data will also be presented to the US FDA in mid 2003 for similar medical claims to be made to the American public. Currently, the HairMax LaserComb is classified as a Cosmetic Device in the USA that promotes thicker, fuller, healthier hair.
“Low Level Laser Therapy (LLLT) has been used internationally since the 1960s mostly for wound healing and pain relief”, states Dr. Martin Unger, MD, a world authority in hair restoration and Medical Director for Lexington International, “LLLT is now starting to become recognized in North America as an effective modality for Alopecia (Hair Loss) and other dermatological medical conditions.” Dr. Unger adds “The HairMax LaserComb is also the first therapy to have shown an increase in hair strength with clinical data indicating an average increase of 79% in tensile strength.”
The LaserComb complies with FDA regulations for laser safety and is patented in the USA with patents pending in 104 countries around the world.
The HairMax LaserComb debuted in March 2001 and has received wide public and press attention. The HairMax LaserComb has been highlighted by TIME Magazine as one of the "Inventions of the Year". To date, the HairMax LaserComb has well over 10,000 satisfied users in 54 countries.
Lexington International had its beginnings in Sydney, Australia where a prototype of the LaserComb was developed. The company moved its headquarters to Boca Raton on Florida’s InternetCoast in 2000, where the HairMax LaserComb is also manufactured.
For more information on the HairMax LaserComb, please visit http://www.hairmax.co.za