FREDERICK, MD--(Marketwire - June 01, 2009) -
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The study was conducted between January 15 and May 15, 2009 involving 48 active devices and 35 placebo devices. Of the active patch group, 71% reported either complete elimination or a reduction in their typical menstrual pain symptoms. 11% of those in the active group reported a complete elimination of pain, while the average amount of pain reduction in the remainder was 55%. 48.6% showed at least a 50% reduction in pain associated with dysmenorrhea. Within the responder control group (placebo) no patients reported complete elimination of pain while the reduction in pain averaged 20%. The differences in positive response to either the active or control patch was of statistical significance. (p < 0.05)
"This study shows the Allay Patch is an effective and safe non-drug method for use in the treatment of primary dysmenorrhea," commented Dr. Barry Eppley, MD, DMD. "It can be used as a primary treatment method for those women with moderate dysmenorrhea who prefer not to take medication. In more severe cases of dysmenorrhea it can be an adjuvant treatment to reduce the amount or duration of other oral medications."
Andrew Whelan, CEO of BioElectronics Corporation, added, "We are very excited about the results of this study. Between 60% and 70% of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to significantly restrict daily activities. With a very limited set of options for pain reduction, we believe Allay, which offers a highly effective, safe drug-free solution can be a very significant product for our company. Over the next few weeks we will be submitting this data to the FDA in our 510(k) submission to receive an indication for reducing menstrual pain symptoms, including cramps and abdominal pain."
BioElectronics has been working closely with several principal investigators on various clinical trials, all of which it adhere to Good Clinical Practices and are Institutional Review Board (IRB) supervised. The Company expects to announce results of its heel pain and breast augmentation surgical recovery studies over the next few weeks and results of its lower back pain and ophthalmology studies, and possibly other studies, which are currently either ongoing or being organized, by the end of the third quarter.
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast™ Therapy (www.healfasttherapy.com) and Allay™ family of inexpensive, disposable drug-free anti-inflammatory devices. These devices utilize embedded battery operated microchips to deliver weeks of home therapy for only about a dollar a day. The unique delivery system, using patented technology, provides a cost effective patient friendly method to reduce soft tissue pain and swelling. ActiPatch is approved by health Canada for the relief of pain and musculoskeletal complaints. The US government food and drug administration (FDA) has cleared the use of the product for reducing edema (swelling) following blepharoplasty and the European Union has approved the product as a Class II pulsed electromagnetic medical device as have numerous other international agencies. For more information please see http://www.BioElectronicsCorp.com.
Safe Harbor Statement
This news release contains forward-looking statements related to future
growth and earnings opportunities. Such statements are based upon certain
assumptions and assessments made by management of both companies in light
of current conditions, expected future developments and other factors it
believes to be appropriate. Actual results may differ as a result of
factors over which the company has no control.
For media inquiries, please contact:
Joe Noel
BioElectronics Corp.
(925) 922-2560
