FREDERICK, 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.
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, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who coordinated the 510(k) effort, said, “The clinical data is robust and our team has made a strong case. We look forward to a successful review of the application with the FDA.”
Keith Nalepka, VP of Sales/Marketing, expressed enthusiasm on the market opportunity: “Obtaining musculoskeletal and postoperative pain clearances will make ActiPatch and RecoveryRx devices available to more than 100 million Americans seeking safe, drug-free pain relief.”
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.tryactipatch.com.
Source: BioElectronics Corporation
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