BioElectronics Completes Menstrual Pain Clinical Study - Allay(TM) Therapy For The Treatment Of Menstrual Pain

Main Category: Women's Health / Gynecology
Also Included In: Pain / Anesthetics
Article Date: 12 May 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced its clinical study on the use of Allay(TM) Therapy for the treatment of menstrual pain and cramping (primary dysmenorrhea) will conclude on May 8. BioElectronics intends to file 510(K) premarket notification for the indication of reducing menstrual pain symptoms with the U.S. Food and Drug Administration by the end of May.

"Participants were recruited quicker than we had initially expected, allowing us to assemble our data a month ahead of schedule," commented Barry Eppley, M.D., D.M.D., the study's primary investigator. "There has been a huge amount of enthusiasm regarding our research; many more women than we needed requested participation. The study's results will be published over the next few weeks."

Andrew Whelan, CEO of BioElectronics Corp., commented, "Between 60 and 70 percent of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to restrict their daily activities. BioElectronics believes a multimillion dollar market exists for the treatment of primary dysmenorrhea. Our version of PEMF therapy offers strong promise for the reduction or alleviation of such discomfort."

The Allay study was conducted by Dr. Barry Eppley, of Indianapolis, Indiana and Dr. Sheena Kong, of San Francisco, California.

In the initial pilot study, which was released during October of 2008, 23 female patients (ages 19 to 37) with problematic menstrual issues used the Allay Patch continuously for five days following the onset of their menstrual period. The women rated their pain over this time frame using the same 1-10 pain scale that they had used during a control period. During the control period, the average composite pain rating was 7.8 with average daily composite pain ratings from day one to five at 8.3, 7.9, 7.4, 6.5 and 5.7, respectively. During the Allay treatment sessions the average composite pain rating was only 5.4, with average daily composite pain ratings of 5.7, 4.8, 4.3, 3.4, and 2.1. This correlates to overall pain reduction on a daily basis of 31 percent, 39 percent, 42 percent, 48 percent and 73 percent respectively.

Source
BioElectronics Corporation