HairMax Achieves New Milestones in Hair Growth with Statistically Significant Clinical Studies and FDA Clearance

Lexington International, LLC is pleased to announce that it
has successfully completed 2 clinical studies of the HairMax
LaserComb proving the efficacy and safety of 3 new devices for the
treatment of androgenetic alopecia (hereditary hair loss). The
analysis showed that 95.4% of participants using the HairMax
LaserComb experienced hair growth. Furthermore, the average
increases in hair count for participants in the HairMax LaserComb
group was 20.4 hairs per centimeter squared, which is considered
medically and scientifically significant. None of the participants
in the studies experienced any serious side effects. Based in part
on submission of clinical results, the FDA Granted Class II
Clearance 510(k) K103368 of these medical devices for sale in the
USA for the 'Treatment of Hair Loss and Promotion of Hair Growth'
in males. The two double-blind, device-controlled multi-center
studies were conducted by Zoe Draelos, MD, David Goldberg, MD,
Michael Jarrett, MD, and Abe Mercadis, MD, under GCP (Good Clinical
Practice) guidelines and IRB (Institutional Review Board) approval.
These clinical trials are posted on www.clinicaltrials.gov.
Submission of these data was a major component of the FDA filing
and was a key factor in the agency's decision to clear the HairMax
LaserComb. The FDA 510(k) Clearance further validates the HairMax
as a non-drug option for treating hereditary hair loss in
males.