NutritionBioElectronics Is Filing For 510(k) Clearance With FDA For Its AllayTM Product
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced it is filing an application with the U.S. Food and Drug Administration (FDA) for 510(k) clearance to market its Allay™ Menstrual Pain Relief Patch product. The filing follows a very successful double blinded, placebo controlled clinical trial in which 71% of women in the active group reported either complete elimination or a reduction in their typical menstrual pain symptoms, with 49% showing at least a 50% reduction in pain associated with dysmenorrhea.
"While between 60% and 70% of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to significantly restrict daily activities, there are very few safe alternatives for pain relief," commented Andrew Whelan, CEO of BioElectronics, Corp. "The most widely used treatment for dysmenorrheal is acetaminophen, but it is also the leading causes of liver failure in the U.S(1). The Allay Menstrual Pain Relief Patch offers a far safer, highly effective and drug-free solution for millions of women who suffer from period pain and cramps. We are excited to bring this product to market."
The Allay Menstrual Pain Relief Patch is based on Pulsed Electromagnetic Field (PEMF) therapy, which is proven safe and effective in hundreds of peer reviewed clinical studies. Using advance semiconductor and micro-battery technologies, BioElectronics has achieved a technological breakthrough in shrinking PEMF technology into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin. The product is currently available over the counter in most counties outside of the United States. The filing with the FDA, is designed to make this drug-free pain relieving technology widely available to women within the United States.
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast™ Therapy (http://www.healfasttherapy.com) and the Allay™ family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.
(1) reference: Larson AM et al, Acetaminophen-Induced Acute Liver Failure: Results a United States Multicenter, Prospective Study. HEPATOLOGY 2005;42:1364-1372
Tylenol is a registered Trademark of McNEIL-PPC, Inc.
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