Non-invasive electroceutical maker BioElectronics Corp. (OTCPK:BIEL) said Tuesday it is meeting with the U.S. Food and Drug Administration on two occasions this month to make its case for clearance on expanded uses for its over-the-counter wearable medical devices.
The Frederick, Maryland-based microcap company already markets disposable, drug-free pain management devices under the brands ActiPatch Therapy for back pain and certain musculoskeletal ailments, RecoveryRx for chronic and post-operative wound care and Allay Menstrual Pain Therapy.
Management will first meet with the FDA next Wednesday to discuss widening the therapeutic indications for ActiPatch to all musculoskeletal pain. Currently the device is only green-lighted for knee osteoarthritis and plantar fasciitis.
Last month, the company submitted to the FDA results from a clinical trial evaluating the device for alleviating low back pain. Details of the trial have not be announced by BioElectronics, but VP of Sales Keith Nalepka called the results "impressive" in a recent interview with Uptick Newswire.
A second meeting is scheduled for May 29, where the company is seeking to expand the uses for its RecoveryRx.
Currently, the BioElectronics product is only available via prescription for the treatment of edema following blepharoplasty, a plastic surgery operation for correcting defects, deformities, and disfigurations of the eyelids.
After submitting documentation to the FDA last month on the clinical benefit in treating breast augmentation and C-section patients, the company is wanting to see expanded clearance for RecoveryRX as an over-the-counter treatment of pain and edema following surgical procedures.
In March, the company initiated a clinical trial evaluating RecoveryRx for post-operative pain management in patients undergoing knee replacement surgery.
BioElectronics sees its products as a compelling alternative to help curb the opioid epidemic that has swept across the U.S. Elsewhere, ActiPatch in January received payment coverage from the United Kingdom's National Health System, which management expects to provide a boon to sales.
Shares of BIEL have been soaring in the last month, mushrooming from around $0.001 at the start of April to as high as $0.005 in Tuesday morning action from a close Monday at $0.0047. As the day wore on, profit taking set in, driving shares down to $0.0033 for a loss of 29.8% on the day as the closing bell approaches.
