BioElectronics: Results of Menstrual Pain Study -- High Efficacy With 100% Safety

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Mon Jun 1, 2009 9:01am EDT

  FREDERICK, MD, Jun 01 (MARKET WIRE) -- 
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive,
disposable drug-free anti-inflammatory devices, today announced the
results of a randomized double-blind, placebo and positive controlled
clinical trial of its Allay(TM) Menstrual Pain Relief product. The
clinical study, which involved 91 females with moderate to severe
menstrual pain symptoms, demonstrated very high efficacy with no safety
issues.

    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(R) Therapy,
RecoveryRx(TM) Devices, HealFast(TM) Therapy (www.healfasttherapy.com) and
Allay(TM) 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

Copyright 2009, Market Wire, All rights reserved.

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