BioElectronics Corporation (BIEL.PK)
FREDERICK, MD–08/08/11- BioElectronics Corp. (Pinksheets: BIEL.PK – News), the maker of inexpensive, disposable drug-free topical pain devices, is pleased to announce it has filed a response to the FDA concerns on the mechanism of action for the Company’s Allay™, Menstrual Pain Therapy product. This response is predicated on additional physiological research, independent studies, and confirming bench testing to verify the working basis for the clinical results produced by its therapy. The research has established a unique patentable mechanism of operation and justification for moving the device into the FDA’s lower safety Class II category. Additionally, the defined safety profile of the mechanism of operation demonstrates less risk than the FDA’s approved Class I, over-the-counter heat products.
"We are very pleased to inform the industry and our investors that we have responded to the FDA’s concerns with a defined and viable mechanism of action. The energy emitted by the Allay device was previously thought to act as only an undefined non-thermal mechanism. We have provided the FDA with extensive performance data that establishes the physics and clinical efficacy of our exceptional therapy. The Allay device offers a simple way of providing dual electrical and continuous low-level, safe, deep heat therapy. This product brings a very significant level of monthly comfort, mobility, and pain relief to millions of women around the world."
Recognized by the Wall Street Journal as one of the top medical innovations of 2009, Allay is recommended by physicians as a safe and effective treatment. In fact, clinical study results show that 77.1% of women using Allay reported complete elimination or significant reduction in their typical menstrual symptoms. More importantly, the Company is very pleased with Allay repurchase results.
Mr. Whelan continued, "Last week we announced that we are expecting a near-term decision from FDA relative to our RecoveryRx™ surgical recovery product. Our FDA reclassification filing for our Allay Menstrual Pain Therapy product is a separate issue and thus we are now waiting for a second separate decision. We have approached both responses to FDA based on hard scientific facts and we believe we have supplied the examiners with a strong body of evidence in answering their questions. We are eagerly awaiting near term FDA’s responses relative to both of these profound healing and pain relieving therapeutic agents."
About BioElectronics Corporation
BioElectronics Corporation is an award winning medical device developer and manufacturer of advanced medical devices. Its products are ActiPatch® Therapy, for over-the-counter treatment of back pain and other musculoskeletal complaints, the Allay™ Menstrual Cycle Pain Therapy, and RecoveryRx™ for surgical procedures and wound care. The unique therapy delivery system, using patented technology, provides a cost-effective home care to reduce soft tissue pain and swelling. For more information, please seewww.bielcorp.com.