Bioelectronics Corporation Files for Premarket Notification of ActiPatch, Following Report on Positive User Feedback

Bioelectronics Corporation Files for Premarket Notification of ActiPatch, Following Report on Positive User Feedback

BioElectronics Corporation, a leader in providing non-pharmaceutical, over-the-counter pain therapy devices, announced earlier this month that it has successfully published its comprehensive ActiPatch 7-day trial user registry study in the acclaimed medical journal Pain Management. The registry study logs 44,000 device users, with feedback from more than 5,000 patients suffering from chronic pain.

Today, about 20-40% of the global population is estimated to suffer from chronic pain, a prevalence greater than diabetes, heart disease, and cancer combined. Of this number, 80-85% are likely to be musculoskeletal in origin. According to the survey, 86% of these patients (diagnosed with osteoarthritis, rheumatoid arthritis, fibromyalgia, sports injuries, post-surgical pain, tendonitis, and neuropathy) who are dependent on 2 types of pain medications said that before using ActiPatch, they would complain of pain with a scale of 8+ on an 11-point VAS scale. Upon using ActiPatch, they reported a decrease in perceived pain by an average of 57-65%, without suffering any side effects.

Three months after, 80% of ActiPatch users were found to have continued using the product, with 93% of the survey’s respondents vouching for its significant, long-term benefits for pain relief.

Dr. Deepak Kotak, Executive VP of BioElectronics, a Fellow of the Royal College of Anesthesiologists said in a recent news release, “Musculoskeletal pain is an increasing problem with few appropriate, safe, drug solutions.  ActiPatch is a safe, affordable, self-treatment for chronic pain.”

Following these positive findings, the company also announced its filing of a 510k Premarket Notification for ActiPatch with the US Food and Drug Administration. This application covers the product’s indication as an adjunctive treatment of pain of musculoskeletal origin and edema.

“I am pleased with the strength of this filing and confident that it will satisfy the agency’s staff,” said Andrew J. Whelan, President.  “Our request for over-the-counter market clearance is strengthened by our explanation of the novel mechanism of action, three clinical trials on using ActiPatch for osteoarthritis, plantar fasciitis and post-operative pain, user data, and the international sales of hundreds of thousands of devices.”


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