FREDERICK, MD--(Marketwire -08/25/11)- BioElectronics Corp. (OTCQB: BIEL.PK - News) (Pinksheets: BIEL.PK - News), the maker of inexpensive, disposable drug-free topical pain devices, today announced a new clinical study designed to prove the efficacy and safety of its products for post-operative pain reduction following Cesarean Section surgical procedures. Jose Carvalho, MD, PhD, FANZCA, FRCPC, Professor and Director of Anesthesia and Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital, a leading authority on pain management, is the lead investigator for this significant post-operative pain study. As of today, approximately 20% of the 200 patient IRB-supervised, double blinded, placebo-controlled study has been completed.
"C-section surgeries involve relatively complex incisions penetrating the abdomen and uterus, usually requiring significant levels of narcotic pain medications to control pain during post-operative recovery. Clinical research demonstrating the reduction of pain, accelerated postoperative recovery along with decreased narcotic pain medication use during C-section recovery will help significantly in the broader acceptance of our RecoveryRx product line," commented Andrew Whelan, CEO of Bioelectronics. "With the successful completion of this important clinical study, we will use the results to file another FDA request for the specific indication of use for C-section surgical recovery, complementing our expected FDA clearance for post-operative pain and edema. There are approximately 1.4 million cesarean deliveries each year in the United States making this a substantial market opportunity for BioElectronics."
Results from Dr. Carvalho's study, along with the data from the blepharoplasty, wound care, heel pain, and breast augmentation studies, will be published to further document the clinical evidence of our unique efficacious and cost effective products.
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
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