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BioElectronics Files FDA Applications for Treatment of Musculoskeletal & Postoperative Pain
BioElectronics Files FDA Applications for Treatment of Musculoskeletal & Postoperative Pain.
About this update from Bioelectronics Corp.
[{"type":"text","content":"\nFREDERICK, MD, Feb. 12, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that two Traditional 510(k) Premarket Notification applications were filed with the U.S. Food and Drug Administration (FDA). The applications were for the ActiPatch® and RecoveryRx® medical devices for market clearances of “over-the-counter adjunctive treatment of musculoskeletal pain in women”, and “over-the-counter adjunctive treatment of postoperative pain”, respectively.\n The ActiPatch is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually). The medical community indicates that women are at a higher risk of developing chronic musculoskeletal pain, may experience pain more frequently and that women are more likely to use opioids for pain. The current application includes robust clinical evidence on women obtained from three clinical studies: knee osteoarthritis, plantar fasciitis and low back pain. Obtaining market clearance will position ActiPatch as a unique product that offers safe, drug-free pain relief for musculoskeletal complaints such as back, neck, hip, shoulder and carpal tunnel pain. The RecoveryRx is currently FDA-cleared for prescription adjunctive treatment of edema following blepharoplasty (eyelid surgery). More than 15 million Americans experience postoperative pain annually. Despite existing multimodal pharmacological approaches such as NSAIDS and opioids, more than 50% of patients report severe postoperative pain. The current application includes robust clinical evidence from two studies: cesarean section and breast augmentation. Obtaining market clearance will allow RecoveryRx to enhance the effectiveness of existing multimodal therapies in reducing postoperative pain, thus reducing a patient’s risk of developing chronic postoperative pain and also reduce their exposure to long-term effects of opioid/NSAID therapy. The 510(k) applications were prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario, Professor, Duke University, Ian Rawe,...