BioElectronics Announces Withdrawal and Planned Resubmission of 510(k) for General Musculoskeletal Pain
Frederick, MD - ( NewMediaWire ) - May 22, 2019 - BioElectronics Corporation (OTC PINK: BIEL) www.bielcorp.com, the maker of non-invasive electroceutical devices, announced today that it has voluntarily withdrawn its 510(k) application for “over-the-counter adjunctive treatment of musculoskeletal pain in women” to the U.S. Food and Drug Administration (FDA), due to the availability of data that can support the more valuable, non-gender specific indications of use.
The ActiPatch is FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually). The 510(k) that was submitted in February 2019 was to seek expanded clearance on treatment of general musculoskeletal pain in women and included robust clinical evidence on women from three ActiPatch clinical studies: knee osteoarthritis, plantar fasciitis and low back pain.
However, interim data from a randomized clinical study investigating the effectiveness of ActiPatch in reducing neck osteoarthritis (https://clinicaltrials.gov/ct2/show/NCT03542955) recently became available to the Company. This data indicated that there was sufficient statistical evidence to seek expanded treatment indications on both men and women. The Company conveyed to the FDA that it intends to submit the new data and replace women-only treatment indications with treatment indications for both men and women. However, the FDA responded that it would not have adequate time to exhaustively review the new data within the original 90-day review window, instead recommending that the current application be withdrawn, and a fresh application be submitted with the new data for expanded indications of “over-the counter treatment of musculoskeletal pain”.
“In our last interaction with the FDA, their staff were very receptive to the idea of using data from the neck osteoarthritis study to seek general indications for both men and women. The neck osteoarthritis study represents our largest clinical study and provides robust data that the ActiPatch reduces pain more effectively than a prescription NSAID,” said Dr. Ian Rawe, Ph.D., Director of Clinical Research for BioElectronics.
“We are confident that the FDA will view the new data favorably and help us get to the finish line of getting clearance for general musculoskeletal pain. The Company will submit the new 510(k) application within the next few weeks. Due to heightened efficiency and new review guidelines at the FDA, the turnaround time on the 510(k) will be relatively short,” said Dr. Sree Koneru, Ph.D., VP of Product Development for BioElectronics.
As a side note, the Company is preparing to file its response to the FDA’s request for additional information on the postoperative pain 510(k) application, within the next week.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.tryactipatch.com