For Immediate Release
IN CLINICAL TRIALS
BOCA RATON, FL, Sept 12, 2002 – The HairMax LaserComb, a hand-held laser device that promotes thicker, healthier hair is undergoing clinical trials The data collected will be submitted to the United States Food and Drug Administration in hopes of receiving market clearance for additional claims.
The announcement was made today by Lexington International LLC, manufacturer of the HairMax LaserComb. The LaserComb is a breakthrough device for delivering the effects of Low Level Laser to the hair and is the only hand-held laser designed and patented for hair.
“This clinical trial is a significant undertaking and we are pursuing this trial because we have genuine confidence in its success", according to David Michaels, Managing Director of Lexington International LLC.”
Clinical trials began in April and the company has now passed the very important three-month mark. Results to this point are extremely encouraging. The trials should be completed and the results submitted to the FDA in the early spring.
The HairMax LaserComb is a Low-Level Laser, which complies with FDA laser safety requirements and is currently marketed as a cosmetic device capable of producing thicker, shinier and healthier hair.
Nationally and internationally there is a great amount of enthusiasm for the potential of low-level laser for hair. User feedback Lexington has collected to date suggests that more than 90% of users achieve some positive benefits and results. "In general, about 45% of users see noticeable indications of benefits from use of the LaserComb within the first 6 weeks," according to Dr. Martin Unger, Lexington's Medical Director "Another 45% realize indications from 6 to 12 weeks and 5% see subtle improvements after 12 weeks.
The HairMax LaserComb debuted in March 2001 and has received wide public and press attention. The HairMax LaserComb, which was named one of TIME Magazine's "Inventions of the Year", is receiving favorable press from numerous national magazines, newspapers and television news programs.
There is presently no other product on the market that directly competes with the HairMax LaserComb because it is the only portable, hand-held laser product designed for hair.” Adds Michaels: "On top of that, the patent has been approved in the USA and is pending in more than 100+ countries, ensuring that the LaserComb will be the only hair device of its kind for some time."
Lexington International had its beginnings in Sydney, Australia where a prototype of the LaserComb was developed. The company moved it headquarters to Boca Raton on Florida’s Internet Coast in 2000, where the HairMax LaserComb is also manufactured.