FDA Controlled Study Results:
MEP-90 Laser Hair Growth System
To gain FDA clearance of the MEP-90 used by HRI of DFW, a comprehensive clinical test was completed at the Koher Center for Hair Restoration, with Institutional Review Board (IRB) preapproval and oversight. Each subject tested during the MEP-90 efficacy determination received a total of 36 treatments. The 20-minute treatments occurred over a period of 18 weeks.
Our exclusive MEP-90 Laser Hair Therapy System has received FDA 510(K) clearance (Approved #K091496) for women with female pattern thinning (androgenetic alopecia). These non-surgical hair loss treatments are NOW available by prescription only, under a doctor’s supervision and only at Hair Restoration Institute of DFW in the Fort Worth area.
Results of FDA Study:
- After 20 treatments (Phase 1)
- 92% of the patients presented an increase hair count of at least a minimum of 10% with 60% having an increase of a minimum of 30% increase in hair.
- Phase 2: (After 36 treatments)
- 96% of patients presented an increase hair count of at least 20% with 88% having an increase minimum of 30% more hair.
- Phase 3: (After 52 treatments)
- An astounding 97% of patients presented an increase hair count of a minimum of 20% with 77% having a minimum increase of 51% more hair.
- An IRB pre-approved clinical trial with oversight was performed.
- Each subject received a total of 36 20-minute treatments over 18 wks
- Results were reviewed at 10-weeks (20 treatments) and 18-weeks (36 treatments) levels
- After 20 treatments (10 weeks) 92% of subjects had increased hair counts of >+10% with 57% demonstrating an increase of 30%.
- 98% of subjects indicated a medically-significant stabilization of rate of hair loss.
- After 36 treatments, 97% of subjects had an increased hair count of >+ 20%. A total of 89% of all subjects demonstrated an increased hair count of >+30%, with 57% demonstrating an increased hair count of >+50%.
- Read the full FDA 510(k) clearance on the FDA website: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091496.pdf