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FREDERICK, MD, May 02, 2018 -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that two meetings have been scheduled with the US Food and Drug Administration (FDA) to seek expanded over-the-counter (OTC) clearances for their drug-free, wearable medical devices.
The first meeting will take place on May 9th, 2018 to seek expanded indications for OTC treatment of all musculoskeletal pain for its ActiPatch® medical device. BioElectronics currently has OTC clearances for adjunctive treatment of two types of musculoskeletal pain: 1) Knee osteoarthritis 2) Plantar Fasciitis. Per the FDA’s requirement to obtain clearance for all musculoskeletal pain, the company submitted the results of a low back pain clinical study, via a Pre-Submission in April 2018. Full details about the study can be found at the NIH’s clinical trials listing page.
The second meeting will take place on May 29th, 2018 to seek expanded indications for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device. BioElectronics currently has a prescription-only clearance for the treatment of edema following blepharoplasty (eye-lid corrective surgery). The company has submitted clinical evidence to the FDA from a breast augmentation study and C-section study, via a Pre-Submission in April 2018.
Sree Koneru, Ph.D., VP of Product Development at BioElectronics, expressed confidence in the upcoming meetings and in the strength of the clinical evidence. “The clinical studies that were submitted have been conducted in an independent and rigorous manner, so we are looking forward to working with the FDA and seek their guidance to obtain expanded market clearances in a timely manner,” Mr. Whelan said.
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.
Paul Knopick 9402623584 [email protected]
