BioElectronics Corporation, maker of consumer medical electronics products for pain management, announced the filing of a 510(k) premarket notification for ActiPatch therapy with the US Food and Drug Administration.
The market clearance request is for the adjunctive treatment of musculoskeletal pain and edema. Musculoskeletal pain accounts for 80 to 85 per cent of all chronic pain affecting 116 million Americans. Its prevalence exceeds that of heart disease, diabetes and cancer combined. ActiPatch addresses a large unmet medical need and provides a safe efficacious new therapeutic modality to mitigate the devastating side effects of drug treatment. Walgreens Boots Pharmacies in the United Kingdom has chosen ActiPatch to provide chronic pain sufferers an affordable $30 drug free, superior pain relief that is 100 per cent safe.
“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. The filing is further strengthened by the publication last week of the results of the United Kingdom and Ireland Registry assessment of 5,000+ users in Pain Management. The article reports the outstanding effectiveness of participants’ use of the devices for back, knee and other muscle and joint pain for a range of medical conditions including osteoarthritis, rheumatoid arthritis, fibromyalgia, sports injuries, and post-surgical pain.”
The urgency to provide a safe, effective and affordable treatment for pain without the dangers of narcotic and non-steroidal anti-inflammatory drugs should be a major factor in the FDA taking prompt and positive action.