BioElectronics Applies for FDA’s Opioid Alternative Innovation Challenge Program
FREDERICK, MD, Aug. 13, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, is pleased to announce that it has submitted an application to the U.S. Food and Drug Administration’s 2018 Opioid Innovation Challenge. This challenge was designed by the FDA to spur the development/deployment of medical devices that can help combat the opioid crisis by preventing/treating opioid use disorder. Click for FDA Challenge Website.
There are more than 245 million opioid prescriptions written annually in the US. BioElectronics’ products are FDA-cleared, nonprescription neuromodulation medical devices that provide pain therapy as an alternative to opioid medications. There are several published clinical and large registry studies indicating that individuals who use BioElectronics’ products to treat chronic pain (musculoskeletal, neuropathic, postoperative, other non-specific etc.) often reduce or eliminate their use of opioid medications.
Ian Rawe, Ph.D., Director of Clinical Research and Sree Koneru, Ph.D., VP of Product Development at BioElectronics, authored the application. “We are confident with the quality of our application, our technology, and our safety/efficacy evidence for the program,” said Dr. Koneru. The FDA will work with the participants to accelerate regulatory approval by providing “Breakthrough Product” designations.
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
Contact: Paul Knopick 940.262.3584 email@example.com