Lexington International Celebrates Its 10-Year Anniversary and Lists HairMax LaserComb Milestones

In 10 years, Lexington International, LLC has become a worldwide leader in the development of laser phototherapy devices with the successful marketing of the HairMax LaserComb® around the world

Sept 2010

Lexington International, a developer and manufacturer of the laser phototherapy device the HairMax LaserComb, celebrates its 10-year anniversary. The Australian founder of the company recognized the devastating effects that hair loss has on people, and based on his successful experience with lasers to treat his hair loss, established a goal to develop and bring to market effective, safe and convenient treatment options.

This effort culminated in the 2000 introduction of the revolutionary HairMax LaserComb which has made a positive difference in the lives of hundreds of thousands of individuals with hereditary hair loss around the world.

The design and development of the HairMax began in Australia in 1985. The founding director, Henry Pearl was a pioneer in the use of laser technology at a hair care clinic and research center in Sydney, Australia.

The HairMax is now marketed in over 145 countries and has gained significant market share in local markets. Further, the HairMax has become a standard of care for the treatment of androgenetic alopecia by thousands of health care professionals who treat hair loss and has become an integral part of their treatment armamentarium.

“Mr. David Michaels, Managing Director of the company stated: “Lexington’s 10-year anniversary represents a realization of the vision and determined effort which has been based upon the focus on four vital factors: A dedication to enriching the lives or those suffering from hair loss, a keen focus on the objective of bringing an effective medical device to market, a company commitment to recognize and attract experts, and a deep commitment to original research and development”.

Further, Mr. Michaels said, “These factors enabled a dedicated team to transform a vision into reality and to positively make a difference in peoples’ lives”.

While two drugs were approved to treat hair loss when the company began, Lexington identified a market need for an effective non-drug alternative for the treatment of the condition.

The company began proprietary research and development of a medical laser device to incorporate the scientific rationale that laser light energy can be collected in the mitochondria of the cells to transfer energy to produce ATP, an “energy transporter” which would stimulate the growth of hair in the follicle.

This led to an ongoing ten year effort which so far, has seen the development and introduction of 4 models of the HairMax LaserComb.

Lexington looks forward to continuing its commitment to research, development and marketing of the latest advances for treatment of hair conditions.

Timeline of Key Milestones:

2000 - HairMax was named Time Magazine’s “Invention of the Year”

2001 - Establishment of Medical Advisory Board of experts in the field of hair science

2002 – Introduction of the HairMax LaserComb Premium model for improvement in hair health

2002 - Lexington receives a award from US Department of Commerce for ‘Commercial and Export Achievement’

2003 - First IRB Clinical Study to qualify and quantify the efficacies of the HairMax as a medical device for treating androgenetic alopecia (hair loss)

2005 – Initiation of major multi-center clinical studies to prove the efficacy of the HairMax LaserComb in treating androgenetic alopecia in males

2006 - Completion of clinical studies and submission of a 510(k) to the FDA for Clearance for marketing

2007 - FDA Class 2 Clearance for marketing granted for the promotion of hair growth in males with certain classes of androgenetic alopecia

2007 - Launch of the HairMax LaserComb to the medical community including dermatologists and hair restoration surgeons

2009 - Completion of an experimental study which showed that laser energy applied to hair follicles ex-vivo stimulated elongation of hair.

2009 - Publication of the results of the clinical study contained in the 510(k) submission to the FDA in a peer review journal

2009 - Receipt of U.S. President’s “E” Award, which recognizes successes in world markets and subsequent contributions to the U.S. economy.

2009 - Initiation of 4 clinical multicenter studies on the efficacy of the HairMax in both males and females.

2010 - Launch of 3 new models of the HairMax LaserComb in international markets

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