FREDERICK, MD, March 19, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce the commencement of a clinical study investigating the efficacy of its RecoveryRx® device for postoperative pain management and recovery following total knee arthroplasty surgery. Currently there are 700,000 total knee replacement surgeries in the US alone and are projected to grow 673% to 3.5 million procedures per year by 2030.
Knee Arthroplasty (knee replacement) generally occurs due to degenerative osteoarthritis in the knee joint. While the procedure is common, managing post-operative and long-term pain can be challenging owing to hypersensitivity of nerves in the knee. This nerve hypersensitivity is known as central sensitization and develops over many years due to the underlying osteoarthritis. Disrupting abnormal pain signaling in the nerves is key to reducing the hypersensitivity and providing lasting pain relief. In case studies, RecoveryRx® has shown to be of great clinical value with regards to postoperative pain management and improving long term pain management in subjects undergoing total knee replacement.
The clinical study will involve 40 subjects who are already scheduled for a knee replacement. Each subject will be randomly assigned to receive an active device or placebo device. Enrollment into the study has been initiated, and the study is expected to be completed in December 2018. Full details can be viewed on the clinicaltrials.gov website (NCT03395444). The study is being conducted at the New Mazloum Hospital, Tripoli, Lebanon. Dr. Omar Tabbouche, our distributor in Lebanon, is managing the study and is aggressively introducing BioElectronics’ innovative medical devices into the Lebanese healthcare marketplace.
“RecoveryRx technology has already been shown to reduce knee osteoarthritis pain, so we are confident that this study will demonstrate the clinical efficacy of the device. Additionally, this study will help us gain regulatory clearance and allow for marketing as the standard of care following joint replacement surgeries,” said Dr. Ian Rawe, Ph.D., Director of clinical Research at BioElectronics.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit?www.bielcorp.com
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