LASER THERAPY FOR WOMEN’S HAIR LOSS: BREAKING NEWS - NEW FDA CLEARANCE FOR FEMALE PATTERN BALDNESS FOR A LASER DEVICE

March 9th, 2010:
I, OverMachoGrande -the chief editor of WorldHairLoss.org and the proprietor of this fine establishment you are in right now- am proud to be the first source to publicly report that a new FDA clearance for female pattern baldness has been issued for the MEP-90 Hair Growth Stimulation System -yes, a laser device.

Laser Therapy -also known as LLLT- now joins Rogaine (2% Minoxidil) as the only FDA approved treatments for female pattern baldness, and obviously adds credence to LLLT as a treatment for other forms of baldness as well.

Adrogenic alopecia is caused by a variety of genetic and environmental factors in both men and women, particularly with an androgen called dihydrotestosterone. The pattern of hair loss in women differs from typical male-pattern baldness. In women, the hair becomes thinner all over the head -often referred to as "diffuse thinning"- and the hairline does not recede. Also, unlike men, androgenetic alopecia in women rarely leads to total baldness.

Approximately 10 percent of pre-menopausal women show evidence of androgenetic alopecia, but age increases the incidence. It is estimated that 50-75 percent of women 65 years or older suffer from this condition.

This marks the second overall approval for hair loss for LLLT by the FDA, with the other one being for MPB with Hairmax Laser Comb (Lexington International).

Study summary:

Below are the highlights of the 510(k) summary -which is the document required by the FDA to show that a device is substantially equivalent to a predicate device.

For the MEP-90 efficacy determination, each subject received a total of 36 each, 20-minute treatments with the MEP-90, over a period of 18 weeks. Results were reviewed at the 10-Week (20 treatment) and 18-Week (36 treatment) levels.

• After 20 treatments (10-Weeks), 92% of the subjects demonstrated an increased hair count of ≥10% with 57% demonstrating an increase of ≥30%. 98% of the subjects indicated a medically significant stabilization of their rate of hair loss.

• After the 36th treatment, 97% of the subject population demonstrated 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%.

• 87% of the subjects indicated the treatments have helped their condition, with 60% reporting their loss rate has further slowed down from the 10-week period, and 65% reported their visible area of the alopecia (bald spot) had gotten smaller.

• 100% of the linear trend plotting for all subjects of their Initial, 10-Week, and 18-Week hair counts demonstrated a historical rate of increased hair growth.

• No subject experienced any adverse event and/or effect from the treatments.

About the device, and what this means to YOU:

We're talking OVERWHELMING stats here. Nobody can deny those numbers! ...But the best thing about this? The diodes used for this machine are the exact same 5mW/650nm AiXiZ diodes with the lens caps removed that we've been using! Woohoo! Yeah, that means you can get these results, too. If you were waiting for a sign from above -especially if you are female- this is it...

This device is not yet on the market, therefore complete device details are yet unknown. However, sources close to WorldHairLoss.org have stated that it should be somewhat similar to the devices shown on http://www.scalplaser.com.

More device details will follow as they become available.

Here is the full 510(k) official summary in PDF form so there can be no confusion on this:


Regards,
John Christian (O.M.G.)
omg@overmachogrande.com