BioElectronics Prepares For General Surgical Recovery FDA 510(k) Premarketing Application Submission

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 10 Jul 2009 - 3:00 PDT

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BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced the Company is currently preparing an application for 510(k) premarket notification for submission to the Food and Drug Administration (FDA) for general surgical recovery. The filing will request an indication for the adjunct of use in palliative treatment of postoperative edema and pain in superficial soft tissue.

"There is overwhelming clinical data demonstrating the application of PEMF therapy significantly reduces postsurgical edema (swelling), pain and speeds healing. There are currently several devices cleared for this indication of use, but these devices are very large, expensive and are in no way portable, so they are neither practical nor marketable for surgical recovery. BioElectronics' portable version of PEMF, for which we recently were granted a patent, is very different. Our biomedical engineers have been able to shrink PEMF technology into a wearable patch that can be applied directly over the site of surgery," commented Andrew Whelan, CEO of BioElectronics. "Many surgeons are already using our products as an adjunctive therapy in the post-operative environment to speed healing and to significantly reduce, or in many cases, completely eliminate the use of narcotics, Tylenol® or acetaminophen, and NSAIDs to control surgical related pain within their patient populations."

BioElectronics Corp.'s RecoveryRX™ devices have already received FDA clearance for the treatment of edema following blepharoplasty, a common plastic surgery procedure. Gaining this additional FDA indication will allow the Company to market its products for use in the general surgical market, which consists of hundreds of thousands of procedures performed each year in both the ambulatory and outpatient environments. The Company recently filed with FDA for clearance to market its Allay™ Menstrual Pain Relief Patch product and is currently in process of completing numerous clinical trials designed to support additional marketing clearance applications with FDA.

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BioElectronics Corporation