|Australian-Developed LaserComb Undergoes Clinical Trials In The U.S.
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Clinical trials are underway on the HairMax LaserComb, a hand-held laser device designed to promote thicker, healthier hair. Data collected during the trials will be submitted to the United States Food and Drug Administration in hopes of receiving market clearance for additional claims.
The LaserComb is produced by Lexington International LLC. The company had its start in Australia, where a prototype of the LaserComb was developed. The firm moved its headquarters to Boca Raton, on Florida’s Internet Coast, in 2000, where the HairMax LaserComb is also manufactured.
Lexington describes the LaserComb as a breakthrough device for delivering the effects of Low Level Laser to hair. It is said to be the only hand-held laser designed and patented for use on hair.
“This clinical trial is a significant undertaking, and we are pursuing this trial because we have genuine confidence in its success", said David Michaels, Managing Director of Lexington International LLC.
The clinical trials began in April of 2002 and passed what the company said was a very important three-month milestone. Results were said to be extremely encouraging. The trials are expected to conclude, ad the results submitted to the FDA, in the early spring of 2003.
The HairMax LaserComb is a Low-Level Laser designed to comply with FDA laser safety requirements. It is currently marketed as a cosmetic device capable of producing thicker, shinier, healthier hair.
User feedback collected by Lexington suggests that more than 90 percent of users achieve positive benefits and results.
"In general, about 45 percent of users see noticeable indications of benefits from use of the LaserComb within the first 6 weeks," said Dr. Martin Unger, Lexington's Medical Director "Another 45 percent realize indications from 6 to 12 weeks, and 5 percent see subtle improvements after 12 weeks."
The HairMax LaserComb debuted in March 2001 and was named one of TIME Magazine's "Inventions of the Year." The product is unique in that it is the only portable, hand-held laser product designed for hair that is now on the market.
"The patent has been approved in the USA and is pending in more than 100-plus countries, ensuring that the LaserComb will be the only hair device of its kind for some time," added Mr. Michaels.