HairMax LaserComb: Research & Development Timeline

2014 – Publication of the results using hair counts to measure efficacy of 4 clinical studies in 225 men and women published in the April 2014
issue of the American Journal of Clinical Dermatology, authored by key opinion leaders in the treatment of hair loss.

2014 – Publication of the results using photographic documentation to measure efficacy of the HairMax LaserComb
a sole or concomitant therapy.

2010 – Key HairMax clinical study demonstrated efficacy in females.

2010 – Clinical studies demonstrated efficacy in males with 3 new models.

2005 – Key clinical and scientific studies with the HairMax demonstrated efficacy in males.

2003 – First HairMax IRB study showed 84.2% success in hair growth and over 45% hair count increase.

2002 – HairMax independent study demonstrated 93.5% increase in hair counts and 78.9% increase in tensile strength.

Below are descriptions of studies conducted by Lexington International, LLC. These studies have helped to validate the efficacy of the HairMax LaserComb for the overall treatment for hair loss and stimulation of hair growth.

2014 – Results of 4 clinical studies of the HairMax LaserComb for the treatment
of hair loss and promotion of hair growth published.

Results using hair counts to assess efficacy of 4 clinical studies in treating pattern hair loss in 225 men and women authored by key dermatologists who are key opinion leaders in the treatment of hair loss, published in the peer review medical journal, the American Journal of Clinical Dermatology, April 2014

2014 – Results a clinical review using photographs to assess efficacy of the HairMax LaserComb
for the treatment of hair loss as sole or concomitant therapy

Results using patient photographs to assess efficacy in treating pattern hair loss in men and women either refractory or intolerant of drug treatments, published in the peer review medical journal the International Journal of Trichology, April-June 2014

2010 – Key Clinical Study in Support of 510(k) Submission to the FDA and Subsequent Clearance to Market in 2011

A double-blind, device controlled clinical study was performed at leading research centers to qualify and quantify the efficacies of the HairMax as a medical device for use in treating androgenetic alopecia (hair loss) in females. Patients, with ages ranging from 25 to 60, were included in a six month evaluation period. Hair counts were measured at baseline, at 16 weeks and at the final visit at 26 weeks. Also, subjects in the HairMax group reported significantly greater increase in hair thickness and density.

At the end of the six-month period, 100% of the subjects in the study showed successful new hair growth with an average hair count increase for all patients of over 20%. These numbers are medically and scientifically significant.

2009 – Evaluation of the Activity of Laser Doses on Ex-Vivo Hair Growth

The results of a study comparing the elongation of hair in a special medium from various laser wavelengths compared to those not exposed to laser energy was conducted. The results after 10 days daily exposure to the various wave lengths showed that they all elongated hair vs. the control hairs that showed no elongation.

2005 – Key Clinical Study in Support of 510(k) Submission to the FDA and Subsequent Clearance to Market in 2007

The results of the key clinical study performed with the HairMax LaserComb which led to FDA clearance to market was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc.

2003 – First IRB Clinical Study

Clinical studies were performed under an Independent Review Board protocol at a leading research center to qualify and quantify the efficacies of the HairMax as a medical device for use in treating androgenetic alopecia (hair loss). Patients, with ages ranging from 26 to 76, were included in a six month evaluation period. Study subjects were required to have thinning hair in the scalp area and have active hair loss at the time of entrance into the study. Analysis was conducted at two locations on the scalp, in the temporal and vertex areas.

Before use of the LaserComb began, each area was clipped and a high-resolution photograph of the location was made. These photographs were loaded into an imaging system that identified each hair shaft. After magnification, a standard hair count was carried out and the number was recorded for comparison later in the study. Following the initial marking and hair count, each patient was provided with a HairMax LaserComb®. They were instructed to use it twice a week for the prescribed time of approximately 10 minutes, covering the entire scalp twice with each treatment.

Each month, the patient would return to the clinic to have the study areas clipped, new photographs taken and new hair counts recorded.

At the end of the six-month period, 97.4% of the patients in the study showed benefits from using the HairMax LaserComb®. Additionally, 84.2% of study participants showed successful new hair growth with an average hair count increase for all patients of over 45%. These numbers are significantly better than any other product tested to date for hair re-growth.

The results of the key clinical study performed with the HairMax LaserComb which led to the original FDA clearance to market was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc. The studies also showed that there were no serious adverse effects in any of the trial participants.

2002 – Study

The second clinical evaluation in 2002 was independently conducted, without any funding by Lexington, published by Dr. Michael Markou in the peer reviewed medical journal ‘International Journal of Cosmetic Surgery and Aesthetic Dermatology’. This evaluation on 35 individuals demonstrated an average of 78.9% increase in hair tensile strength and 93.5% increase in average hair counts.

Initial Studies in Australia

Initial Research and development of the HairMax LaserComb® began in the 1980s in Sydney Australia where CEO Henry Pearl was a pioneer in the use of laser phototherapy in a clinical setting to activate hair growth. The results were dramatic with men experiencing substantial improvements in hair growth, regrowth and overall quality of hair.

The first clinical evaluation conducted in 1993 used a laser-based combination of laser irradiation, laser acupuncture and high frequency electrotherapy, with the proprietary name ‘cell wave therapy’. The evaluation was performed over a 15-month period to ascertain its efficacy in delaying or reversing male androgenetic alopecia. The trial was divided into 3 phases, each of 5 months duration.

1st PHASE: 80% of the actively treated group showed a 27% mean increase in hair density at the end of the first phase…whilst the control group had a loss of 4.5%. This is a statistically significant trend to increase hair density, with a p value of 0.02.

2nd PHASE: This increase in hair density was maintained by the actively treated group.

3rd PHASE: After the actively treated group ceased therapy they had a significant loss of hair density with a p value of 0.001.

Laser Photo Therapy – The Foundation of the HairMax LaserComb®

The use of PhotoTherapy (light therapy) in medicine has a long history. The Egyptians filtered sunlight through precious gems to obtain desired colors of light. Archeologists have found ancient records on Egyptian papyri dating back to 1550 BC detailing PhotoTherapy “treatment.” The Greeks built solarium cities in high mountains to harness the additional ultra-violet light available there for healing tuberculosis. And red light was used to quell the effects of the smallpox virus.

In 1903, the second Nobel Prize in Medicine (Physiology) was awarded to Niels Ryberg Finsen, M.D., in recognition of his contribution to the treatment of diseases with concentrated light energy, “PhotoTherapy”. Dr. Finsen was recognized for opening a whole new avenue for medical science.

It was this Nobel Prize winner’s important discovery in the field of PhotoTherapy that laid the foundation for the invention of the HairMax LaserComb for the treatment of hair loss. Dr. Finsen is also responsible for bringing early credibility to this therapy. Today’s PhotoTherapy devices are used to treat everyone from newborn infants suffering from jaundice to adults seeking relief from skin conditions.

We are confident the HairMax LaserComb will be a major step forward in controlling hair loss and stimulating hair re-growth* – breaking the cycle of emotional pain associated with hair loss.