BioElectronics Corp. (OTCPINK: BIEL) saw a significant drop after the Company announced the U.S. Food & Drug Administration (FDA) declined the company’s 510(k) submission for ActiPatch®, intended for seeking expanded over-the-counter (OTC) indications for the treatment of musculoskeletal pain. In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a mild treatment effect in men. Since gender differences in treatment effects were not identified in prior ActiPatch clinical studies (knee and plantar fasciitis pain), the FDA concluded that the clinical evidence in the current 510(k) application was “not substantially equivalent” to the prior evidence.
The company intends to resubmit the 510(k) application for a more specific indication: relief of musculoskeletal pain for women. Sree Koneru, VP of Product Development, expressed confidence in this strategy, both from a regulatory and marketability perspective. “We are also diligently proceeding with 510(k) applications for US market clearance of postoperative pain (RecoveryRx®) and menstrual pain (Allay®),” he added.
BioElectronics Corp. 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. BIEL innovative pulsed shortwave therapy technology (PSWT) uses low power pulsed electromagnetic fields regulate electrical activity of the nervous system. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications.
BioElectronics OTC product line includes ActiPatch® Musculoskeletal Pain Therapy, Allay® Menstrual Pain Therapy, Smart Insole™ Heel Pain Therapy, and RecoveryRx® Post-operative and Chronic Wounds Therapy. The US FDA clearance is for the company’s flagship product the ActiPatch® Musculoskeletal Pain Therapy, developed to relieve chronic pain. ActiPatch is a drug-free, wearable nonprescription medical device that provides 720-hours (90, 8-hour treatments) of on/off therapy. Most users obtain relief with only 8 hours per day of use, so the device will generally last several months, depending on use. The Company is aggressively pursuing US FDA over-the-counter market clearance to access the United States market. The Companies technology offers significant opportunities in menstrual pain, heel pain, migraine headaches, diabetic neuropathy, postoperative surgery, chronic wounds, bone growth stimulation,and other applications.
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On December 4 BIEL President; Andrew J. Whelan stated in shareholder update:
“While we were all disappointed by the dramatic drop in the stock price, it hasn’t had an impact on the Company’s operations. What is still needed is a cost-effective efficacious painkiller that is also an alternative to opioids. Physicians prescribe, and patients take opioids because they do not have an alternative painkiller. Back pain and post-operative pain are the major uses of opioid. BioElectronics products work when nothing else does because it is The New Technology for Pain Relief. The FDA did two things last week that panicked investors”
Regarding U.S. Food & Drug Administration (FDA) declined the company’s 510(k) submission BIEL intends to:
- Immediately file the new 510(k) applications for musculoskeletal and post-operative pain.
- File the 510(k) application for Allay and continue our research on migraines, over active bladder, pelvic and phantom pain.
- Continue discussions with the 5-active major pharmaceutical potential marketing partners.
- Complete our 8th country deal and aggressively support the seven existing countries with Mundipharma.
- Continue our marketing support of the UK B. Braun same day hip and knee replacement program and detail healthcare professionals to write reimbursable prescriptions.
- Focus on getting the new insole product on the market.
- Fine tune our reimbursable sales and marketing to the VA, the military, nursing homes, and hospices patients.
- Dispose of the SEC’s case tried by an Administrative Law Judge who in 50+ cases over eleven years never ruled against the SEC.
- If necessary, we will get a knowledgeable healthcare investor, in the absence of a major marketing partner.
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Currently trading at a $16 million market valuation BIEL did $211k in sales for the 3 months ended September 30, 2018. The Company has little cash on hand with over $6 million in current liabilities. BIEL is an exciting story in small caps; the Company is already selling its flagship, the ActiPatch and plans to refile the 510(k) application for Allay and continue our research on migraines, over active bladder, pelvic and phantom pain. BIEL has a large shareholder base who believe in the Company and their products and their ability to disrupt a billion-dollar market. We will be updating on BIEL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with BIEL.
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Disclosure: we hold no position in BIEL either long or short and we have not been compensated for this article