US-based non-invasive electroceutical medical devices provider BioElectronics has announced the filing of a 510(k), Premarket Notification application with the US Food and Drug Administration (FDA), for its ActiPatch therapy.
The medical devices firm said that it has filed the application to obtain expanded market clearance for its drug free, over-the-counter ActiPatch Musculoskeletal Pain Therapy medical device, for the indication of ‘adjunctive treatment of musculoskeletal complaints pain’.
BioElectronics sales and marketing VP Keith Nalepka said: “Obtaining full musculoskeletal complaints clearance will make the ActiPatch device available to more than 125 million Americans and paves the way for new products and approved medical claims for the back, knee, muscles, joints, hips, wrists, carpal tunnel, tennis elbow, ankle sprains, Achilles tendonitis, etc.”
The cervical osteoarthritis study shows positive results for ActiPatch
The cervical osteoarthritis (neck pain) study was carried out to evaluate the effectiveness of ActiPatch treatment compared to a standard of care treatment using prescription NSAID therapy, Etoricoxib 60mg.
The subjects in the study were randomly assigned to receive either Etoricoxib therapy or ActiPatch, and the study data shows that both treatments have reduced neck pain, but ActiPatch was statistically significant than that of NSAID treatment.
ActiPatch therapy has previously received FDA approval for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain).
BioElectronics said that the present FDA 510(k) application was prepared by the company’s R&D team comprising State University of New York clinical science and engineering research director Kenneth McLeod, Duke University Gregory Mario and Jeremy Mario professor Richard Staelin, BioElectronics clinical research director Ian Rawe and BioElectronics product development VP Sree Koneru.
Koneru said: “The clinical data represents our largest ever study, and our team has made a strong case. We look forward to a successful review of the application with the FDA.”
BioElectronics is engaged in manufacture of non-invasive electroceuticals and family of disposable, drug-free, pain therapy devices ActiPatch Therapy, RecoveryRx Devices, and Allay Menstrual Pain Therapy.
In July, the company received the FDA clearance for its RecoveryRx medical device, for the treatment of postoperative pain.
