HairMax LaserComb Clinical Trial Update

Lexington is pleased to announce that we have concluded our second clinical trial and will shortly be presenting the clinical hair count data to the FDA.

This was a multi-centered, double-blind, sham controlled study conducted following GCP (Good Clinical Practices) guidelines.

The initial clinical assessment is very encouraging and exciting. Upon guidance received through the FDA IDE process, we decided to divide our overall trial into two studies; the first tested the efficacy of the HairMax LaserComb on males.

The next study focuses on female efficacy and will be begin shortly at a total of 5 sites.

We are currently are recruiting participants in Austin Texas, West Palm Beach, Florida and Orlando, Florida.

If you or anyone you know is interested in participating in this landmark study pleas e-mail info@lasercomb.net
This is Lexington’s second sponsored clinical study.

The first study was conducted in 2002-2004. The clinical data was statistically significant as well and we filed a 510k with the FDA.

However, the FDA rejected this application because of our trial design. In our first study we did not use a sham control and only conducted it at one site.

This unfortunately was due to misguidance from our former Medical Director. However, despite this, we have learned from our mistakes and underwent extensive research into GCP and trial design for our current round of trials.

We will not be able to release this data until after we submit it to the FDA. We are cautiously optimistic and look forward to sharing this data with the whole world.

Lexington International, LLC, headquartered in Boca Raton, FL is a medical device manufacturer. Lexington is ISO accredited and follows all GMP (Good Manufacturing Practices).

At Lexington, we take pride in manufacturing a ‘Made in the USA’ product , focusing on positive user experiences and ensuring total customer satisfaction.

To date, we have exported to 72 countries and are proud to state that many world renowned politicians, celebrities and rock stars are satisfied customers of ours.