SOURCE: BioElectronics Corporation

BioElectronics Corporation

August 26, 2009 10:52 ET

BioElectronics Announces Completion of Clinical Study -- Preparing FDA 510(K) Pre-Marketing Notification for OTC Clearance

Study Led by Dr. David Genecov Shows High Efficacy, 100% Safety and a Significant Reduction in Pain Medication Through Use of ActiPatch®

FREDERICK, MD--(Marketwire - August 26, 2009) - BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the completion of an important clinical study on heel and foot pain, which was led by David Genecov, M.D. FACS FAAP.

Dr. Genecov commented, "Our data on heel and foot pain shows strong efficacy and 100% safety using the ActiPatch® Therapy device. Results for pain reduction are significant as are the data indicating study participants were able to meaningfully reduce their use of pain medication. Our study indicates that ActiPatch's effectiveness, ease-of-use and low cost make it a viable option for the tens of millions of people who suffer from heel and foot pain, including plantar fasciitis. As a physician I am always concerned about the overuse of acetaminophen, narcotics and NSAIDs. Whenever possible our role is to reduce the use of these medications. This study clearly demonstrates that ActiPatch is an effective drug-free tool to control pain."

"We are very excited about the completion of this study, especially the data showing that study participants were able to reduce the amount of pain medication when using ActiPatch therapy. Over the short term we will be using this data to support our upcoming pre-marketing submission to the Food and Drug Administration," commented Andrew Whelan, CEO of BioElectronics. "As the debate relating to over-the-counter pain medications, such as Tylenol®, continues and as consumers are increasingly leery about taking these drugs, we believe our drug-free solution to pain management and healing will continue to gain in popularity. Considering the strength of this data, and due to the fact that ActiPatch is already approved by the FDA for a different indication, we believe our odds for clearance from the FDA are extremely high."

Heel and foot pain, and plantar fasciitis are common conditions affecting tens of millions of people all over the world(1). It has been reported that plantar fasciitis occurs in 2 million Americans a year and 10% of the population over a lifetime(1). It is commonly associated with long periods of work related weight-bearing, and is especially prevalent in non-athletic populations with a high body mass index.

About David G. Genecov M.D. FACS FAAP

Dr. David G. Genecov is a native of Dallas, Texas. After finishing his undergraduate degree in the Plan II Honors Program at the University of Texas, he completed his medical training at the University of Texas Health Science Center in San Antonio. Upon completion of his general surgery residency at West Virginia University, Dr. Genecov became board certified in general surgery. He continued his education at Wake Forest University - Bowman Gray School of Medicine and completed his plastic surgery residency. He then completed a fellowship at the International Craniofacial Institute, Dallas, Texas, in Craniomaxillofacial surgery for adults and children with congenital and acquired deformities. Dr. Genecov joined Dr. Kenneth E. Salyer subsequent to his fellowship, where he later succeeded to Medical Director of the cosmetic and reconstructive practices founded by Dr. Salyer. Currently, he serves as Adjunct Assistant Professor to the Department of Biomedical Sciences at Baylor College of Dentistry, a member of the Texas A&M University System.

Widely published in both national and international literature, Dr. Genecov has also authored four medical book chapters. Dr. Genecov has received numerous awards for academic excellence, his surgical expertise and philanthropy. Most recently he was named one of the country's top surgeons by the independent Consumer Research Council of America for 2004-2005 and has been recognized by Who's Who in America for the 2006 edition.

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.

Tylenol is a registered trademark of McNeil pharmaceutical, Inc.

(1) Risk Factors for Plantar Fasciitis: a matched case-controlled study. Riddle DL, Pulisic M, Pidcoe P, Johnson RE, J Bone Joint Surg Am. 2003;85-A:872-877

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