Apira iGrow Hair for women gets FDA OTC clearance

APIRA Science Inc.’s iGrow (R) Hair Growth System has just been granted FDA over-the-counter (OTC) clearance for promoting hair growth in women with Fitzpatrick skin phototypes I to IV and Ludwig Baldness Scale I to II classifications. The first hands-free, in-home hair growth device awarded FDA clearance for both men and women, the product can now be purchased for hair loss treatment even without a prescription.

The iGrow uses low-level light therapy (LLLT) and a combination of medical-grade LEDs and red laser diodes to provide women and men with varying types and degrees of hair thinning and hair loss with a cost-effective, clinically proven solution. It results in a 37% increase in hair count among women within just 16 weeks of treatment and has zero side effects.

To obtain FDA clearance, Apira Science conducted a double-blind, independently reviewed clinical study called “The growth of human scalp hair in females using visible red light laser and LED sources.” The study aimed to test the efficacy and safety of the iGrow Hair Growth System in promoting hair growth in women. It involved female participants who used the product four times a week for 25 minutes per session. Results indicate a 37% increase in hair count among these women in just four months.

The study complements the award-winning clinical study that shows using iGrow for 16 weeks resulted in a 35% rise in hair count in men. Both studies are published in Lasers in Surgery in Medicine.

According to Jeff Braile, president of the Medical Products Division at Apira, more than 40 million women suffer from genetic hair loss.

“The iGrow is one of just a handful of solutions the FDA has cleared for treating women. iGrow is the only home-use, hands-free device to be cleared by the FDA for both men and women. This puts it in an elite category of hair loss products proven equally effective for both men and women, and enables anyone to effectively treat hair loss from the comfort and privacy of their own home,” Mr. Braile added.

The company will introduce the iGrow Hair Growth System at CES, which will be held from January 6 to 9, 2015 in Las Vegas. Product demonstrations in its booth #75708 will show how the system’s patented red light technology re-energizes cells at the follicle level to regrow thicker, fuller, and healthier hair.