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BioElectronics Expands Clinical Research in Four Key Categories

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BioElectronics filed four applications for grants in order to conduct clinical studies on Diabetic Neuropathic Foot Ulcers, Oral Surgery Pain, Plantar Fasciitis, and Menstrual Pain. Upon completion of the studies, the data will be used for U.S. FDA submissions to gain additional clearances and to support the company's sales and marketing.

Diabetic Neuropathic Foot Ulcers: A 6-week pilot study evaluating ActiPatch™ as an effective adjunct treatment for the healing of recalcitrant wounds yielded positive results. By week 3, fifty percent of the subjects experienced completely recovery and by week 6 subjects experienced an average of 93% reduction in ulcer size. Elliot Udell D.P.M. will be the Primary Investigator for this large-scale clinical trial. Dr. Udell is the president of the American Society of Podiatric Medicine and is a board member of the American Society of Podiatric Dermatology. Dr. Udell is board certified in both Podiatric Primary Care and Pain Management.

Oral Surgery Pain Management: Ten million third molars are extracted annually in the United States. The RecoveryRx™ product will address a significant unmet market need by offering a drug-free alternative to NSAIDs and opioids such as oxycodone and morphine, particularly for kidney compromised, arthritic and cardiovascular patients. Neophytos Demetriades D.D.S, Assistant Professor at Tufts University School of Dental Medicine, is the Primary Investigator for this clinical trial. Dr. Demetriades is a member of the American Association of Oral and Maxillofacial Surgeons, and a fellow of the International Association of Oral and Maxillofacial Surgeons. Dr. Demetriades' initial evaluation of the device generated promising results.

Plantar Fasciitis: Given the positive preliminary clinical data gathered in 2009 we propose to conduct an additional study to evaluate the continuous use of ActiPatch™ (24 hours a day) in order to further decrease pain levels, limit medication use and improve healing times. We have made extensive improvements in our heel pain product line, combining the healing therapy of the ActiPatch™ product with the comfort and support of a gel insole for daytime wear, and redesigning our heel wrap for maximum coverage during the night. The successful completion of this clinical study will translate into an highly effective and low cost system for healing plantar fasciitis.

Menstrual Pain: Andrea Lukes MD is the Primary Investigator for our expanded menstrual pain clinical study. Dr. Lukes is the former Director of Gynecology for the Women's Hemostasis and Thrombosis Clinic at Duke University. Predicated on favorable results from existing studies conducted in 2009, Andrea Lukes MD will conduct a larger study of 120 women to support additional product claims. Dr. Lukes has participated in numerous research programs supported by the NIH and CDC, as well as conducting multiple industry sponsored FDA trials. She continues to actively consult with industry regarding development and implementation of research protocols, including communications and presentations to FDA.