Healthcare Industry News: chronic pain
News Release - April 27, 2010
BioElectronics Announces Revolutionary Device for Treatment of Chronic PainFREDERICK, MD--(HSMN NewsFeed) - BioElectronics Corp. (Pinksheets:BIEL ), the maker of inexpensive, disposable, drug-free, anti-inflammatory devices, today announced a new revolutionary device for the treatment of chronic pain. The new device is based on many of the same core technologies that recently allowed BioElectronics to earn a Wall Street Journal Innovation Award and a U.S. government patent. This new version of the Company's technology, however, utilizes higher frequencies and higher power levels. Bioelectronics believes this new technology qualifies for reimbursement under most government and private health insurance plans.
The latest version of BioElectronics's technology is expected to be considered by the U.S FDA and foreign medical device regulators as an electrical stimulation device rather than within the Shortwave Diathermy device category. Currently, the U.S. FDA considers Shortwave Diathermy devices as Class III devices, which is generally reserved for devices which are life supporting or life sustaining, or for which insufficient information exists to assure safety and effectiveness. Electrical stimulation devices, however, are generally considered Class II devices and therefore BioElectronics believes this new device will also be characterized within Class II by the FDA.
"This new product line will be a strong enhancement to our ActiPatch and Allay brands. With the higher power levels, we believe surgeons and other physicians will see superior pain relief from soft tissue injuries and after surgical procedures from within their patient populations," commented Andrew Whelan, CEO of BioElectronics Corp. "Because we expect this device to be considered an electrical stimulation device and thus a Class II device, as are other electric stimulators, we believe the path toward regulatory clearance will be significantly accelerated allowing us to address a wider market both within and outside of the United States."
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast® Therapy (www.healfasttherapy.com) and the Allay™ family of inexpensive, disposable, drug-free, anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.
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