BioElectronics Corp announced that it is filing an application with the US FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The filing is supported by double blinded, placebo controlled clinical trial. In this trial 71% of women in the active group reported 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. 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 Pulsed Electromagnetic Field therapy is proved safe and effective in hundreds of peer reviewed clinical studies. The Allay Menstrual Pain Relief Patch is based on Pulsed Electromagnetic Field (PEMF) therapy. BioElectronics used advanced semiconductor and micro-battery technologies for 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 Allay Menstrual Pain Relief Patch is currently available outside US. The filing with the FDA is mainly intended to provide drug-free pain relieving technology widely available to women within the US.