SOURCE: BioElectronics Corporation

BioElectronics Corporation

August 03, 2011 09:34 ET

BioElectronics Expecting Near Term Decision From FDA on RecoveryRx™ Product

FREDERICK, MD--(Marketwire - Aug 3, 2011) - BioElectronics Corp. (OTCQB: BIEL) (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce it is currently awaiting a near term decision from the U.S. Food and Drug Administration relative to an additional indication of use for its RecoveryRx™ product. RecoveryRx is a disposable medical device that delivers continuous electromagnetic therapy that when applied to the site of a surgical incision quickly relieves post-operative pain and edema, providing patient comfort while accelerating healing. Management and its consultants have been responding to FDA's questions and have recently attended another meeting at the FDA's offices.

Currently, the Company's products' U.S. FDA clearance is limited to the treatment of edema following blepharoplasty (eye surgery). This additional clearance, a decision on which the Company expects over the coming weeks, will allow BioElectronics to significantly expand the addressable market opportunity.

"For the past few months we have been working with personnel at the FDA on questions they have posed on our application, the functionality of the device and on the efficacy," commented Andy Whelan, CEO of BioElectronics. "We have supplied FDA with an extensive amount of information, which we believe more than adequately addresses their questions. As a result we are expecting a positive result from the application process over the coming weeks."

The RecoveryRx™ device is flexible, comfortable, and easy to apply at the site of surgical incision. Once activated, RecoveryRx begins pulsing a continuous low level current to energize damaged cells in the surgical region, helping remove the effects of trauma so patients can feel better and look better faster than they would have ever thought possible. The low level current that is gently pulsed into the damaged tissue is undetectable, even though the device is continuously working to help the patient naturally heal faster. RecoveryRx™ is extremely safe when used as directed.

Mr. Whelan added, "It has been a long road toward additional clearances here in the United States, but it is a road to which we believe we now see the end. Our recent contacts with FDA have been very positive and as a result we believe significant progress has been made. This additional indication of use is not only important relative to potential sales in the United States, but should also positively impact worldwide sales due to the additional credibility we will gain in the marketplace."

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 see www.bielcorp.com.

FORWARD LOOKING STATEMENTS
This press release contains certain statements that may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that address activities, events or developments that we intend, expect, plan, project, believe or anticipate will or may occur in the future are forward-looking statements. Forward-looking statements are based on certain assumptions and assessments made by us in light of our experience and perception of historical trends, current conditions and expected future developments. Actual results and the timing of events may differ materially from those contemplated by the forward-looking statements due to a number of factors. BioElectronics refers you to the cautionary statements and risk factors set forth in the documents it files with the Securities and Exchange Commission. The company is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact Information

  • Contact:
    Ben Fichter
    BioElectronics Corporation
    (301) 874-4890