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news.BioElectronics, a maker of disposable drug-free anti-inflammatory devices, has reported that its clinical study on the use of Allay therapy for the treatment of menstrual pain and cramping has concluded.
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BioElectronics intends to file 510(k) premarket notification for the indication of reducing menstrual pain symptoms with the FDA by the end of May 2009.
In the initial pilot study, 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 one to 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 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%, 39%, 42%, 48%, and 73% respectively, the company said.
Andrew Whelan, CEO of BioElectronics, said: “Between 60 and 70% 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.”