Bioelectronics Corp (OTCMKTS:BIEL) reported that it filed 510(k) Premarket Notification for its ActiPatch® treatment with the U.S. FDA. The market clearance application is for the adjunctive cure of edema and musculoskeletal pain.
The scope
Musculoskeletal pain accounts for nearly 85 % of 116 million people suffering from chronic pain in the U.S. Its prevalence surpasses that of cancer, heart disease and diabetes combined. ActiPatch therapy addresses a considerable unmet medical need and offers a safe effective therapeutic modality to reduce the adverse side effects of drug therapy.
Walgreens Boots Pharmacies, a firm based in the UK has selected ActiPatch to offer chronic pain patients an affordable drug free, premium pain relief that is stated as 100% safe. Bioelectronics aims to offer US residents the same safe, effective, drug free and affordable pain relief.
The management view
Andrew J. Whelan, the President of Bioelectronics Corp (OTCMKTS:BIEL) said that they are delighted with the strength of this filing. The management is confident that it will meet the agency’s staff. Their demand for over-the-counter market approval is supported by the details of the unique mechanism of action, the clinical studies on utilizing ActiPatch for plantar fasciitis, post-operative pain, osteoarthritis, user results, and the worldwide sales of devices.
Whelan further added that the filing is strengthened by the release of the results in last week of the Ireland and United Kingdom Registry assessment of more than 5,000 users in pain management. The article highlights the remarkable effectiveness of enrolled people’s use of the devices for knee, back and other joint and muscle pain for a number of medical conditions including rheumatoid arthritis, fibromyalgia, osteoarthritis, post-surgical pain and sports injuries.
In last trading session, the stock price of Bioelectronics gained more than 12% to close the trading session at $0.00090. The gains came at a share volume of 126.68 million compared to monthly average share volume of 26.16 million.
