FREDERICK, MD - (NewMediaWire) - July 12, 2018 - BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch® was filed today with the U.S. Food and Drug Administration (FDA). The market clearance requested was “over-the-counter adjunctive use in the treatment of musculoskeletal pain”.
While ActiPatch is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints. Full details about the study can be found at the NIH’s clinical trials listing page: (NIH Back Pain study link).
The 510(k) was 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 spearheaded the 510(k) effort, said, “We are confident with the strength of our data and overall application. Given the FDA’s prior knowledge of the data and prior clearances, we believe that the 510(k) will be processed in a timely manner.”
Keith Nalepka, VP of Sales/Marketing, remarked on the market opportunity: “An expanded market clearance will make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with musculoskeletal pain.”
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
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