BOCA RATON, Fla.--(BUSINESS WIRE)--Apira Science, Inc. today announced the FDA has granted the company over-the-counter (OTC) clearance for its iGrow® Hair Growth System to effectively promote hair growth in males who are classifications IIa-V on the Hamilton-Norwood hair loss scale. The hands-free, in-home hair growth device is now widely available without a prescription for effectively treating male patterned baldness.
The iGrow Hair Growth System can increase hair counts by 35 percent in just 16 weeks of therapy, and now men can easily regrow thicker, fuller, and healthier hair without a prescription from their doctors. The device offers a convenient, cost-effective, and clinically proven solution for androgenetic alopecia—patterned baldness—an ailment affecting more than 70 percent of American men. Unlike pharmaceuticals, topicals, and pills used to treat hair loss, the iGrow's non-invasive LLLT technology has no side effects. With consistent use, men with varying types and degrees of hair thinning and hair loss can experience dramatic results.
“This regulatory milestone represents yet another significant achievement for Apira Science and its iGrow® Hair Growth System,” said Jeff Braile, president, Medical Products Division. “As the first wearable, hands-free, in-home hair growth device to receive U.S. FDA OTC clearance for hair growth in males, iGrow will now allow for more widespread availability for consumers who suffer from hair thinning and loss.”
The system’s patented red light technology, which consists of a highly productive combination of red laser and LED diodes, re-energizes cells at the follicle level to effectively regrow hair. In the clinical study, which was awarded the Best Overall Experimental and Translational Research Award by The American Society for Laser Medicine & Surgery, Inc. (ASLMS), the iGrow re-grew hair 10 weeks faster than leading hand-held laser combs and brushes.
The iGrow Hair Growth System is now available for purchase at www.igrowlaser.com; retail sites NeimanMarcus.com, Nordstrom.com, Bedbathandbeyond.com, Hammacher.com, Drugstore.com, and Frys.com; and also at select Neiman Marcus, Nordstrom, Bed Bath & Beyond, and Fry’s retail locations. The device comes with a six-month money-back guarantee, and retails for $695.
The U.S. is among 40 global markets where the iGrow hair growth device is available, including Mexico, all 28 European Union nations, as well as Canada, Hong Kong, China, Thailand, United Arab Emirates, Singapore, Malaysia, Peru, Taiwan, Vietnam, and Turkey.
About Apira Science, Inc.
Apira Science, Inc. has pioneered low-level light therapy (LLLT) for over a decade. Its iGrow Hair Growth Platform draws on its expertise and innovations in the application of LLLT to deliver a simple, safe, and effective hair growth treatment.
iGrow is a registered trademark of Apira Science, Inc.
iGrow website: www.igrowlaser.com
Product images: http://goo.gl/bJhkPT