New Milestones In Hair Growth And FDA Clearance

Lexington International, LLC has announced the successful completion of two clinical studies of the HairMax LaserComb, proving the efficacy and safety of three new devices for the treatment of androgenetic alopecia. The analysis showed that 95.4% of participants experienced hair growth. Furthermore, the average increases in hair count for participants in the HairMax LaserComb group was 20.4 hairs/cm², 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-centre studies were conducted by Zoe Draelos, David Goldberg, Michael Jarrett, and Abe Mercadis, under Good Clinical Practice guidelines and Institutional Review Board approval. 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 clearance further validates the HairMax as a non-drug option for treating hereditary hair loss in males.

Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects and all of the studies have demonstrated the efficacy and safety of the HairMax LaserComb.