BioElectronics Corporation, a leading developer, marketer, and manufacturer of patented medical devices, has been recently granted a new 510(k) FDA clearance for drug-free musculoskeletal pain treatment device, ActiPatch®. Under this approval from the United States FDA, the company can market the device as safe and effective, equivalent to legally marketed devices.
The recent clearance was obtained for over-the-counter marketing of the medical device, extending the indications for the treatment of musculoskeletal pain to provide long-lasting chronic pain relief. In 2017, the ActiPatch® was FDA-approved for over-the-counter treatment of plantar fasciitis and knee osteoarthritis. This device remains the only PSWT (pulsed software therapy) device with over-the-counter approval for treating any form of musculoskeletal pain.
BioElectronics is the leading provider of disposable, pain therapy, drug-free devices. Apart from ActiPatch® Therapy for back pain and other musculoskeletal treatment, its portfolio includes RecoveryRx®, used to treat chronic & post-operation wound and Allay® Menstrual Pain Therapy.
BioElectronics’ Vice President of Sales and Marketing division, Keith Nalepka, has expressed his anticipation towards exploiting the business opportunities emerging from the FDA-clearance. Under this clearance, the company can market new medical devices for treatment of musculoskeletal pain in knees, hips, wrists, ankles, and elbows, among others, with approved medical claims.
According to the statement made by BioElectronics’ President, Kelly Whelan, the company is aiming to expand market opportunities and capitalize on the recent clearance by offering more products to various partners in retail chain system, which clearly aligns with its 2020 aim to put Original Equipment Manufacturer (OEMs) as important business aspects.
The research and development team that prepared the new 510(k) FDA market clearance application includes Dr. Richard Staelin, Ph.D., Professor Jeremy Mario and Gregory Mario (from Duke University), Dr. Kenneth McLeod, Ph.D. (Director at Clinical Science & Engineering Research Laboratory, Binghamton University), Dr. Ian Rawe, Ph.D. (BioElectronics’ Director of Clinical Research), and Dr. Sree Koneru, Ph.D. (BioElectronics’ Vice President of Product Development).