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MICROCAP DAILY SALUTES BIOELECTRONICS' (OTC:BIEL) PROGRESS
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BioElectronics Corp. (OTCPINK: BIEL) Heating Up as ActiPatch® and RecoveryRx® Gain Traction & Company Looks to Expand into New Markets
By Boe Rimes
BioElectronics Corp. (OTCPINK: BIEL) has been trending up in recent months and it looks as if this may be the beginning of something. The stock has a long history of big moves skyrocketing to $0.007 in summer 2021. Microcapdaily has been reporting on BIEL for years and covered them in triple digits back in November shortly after the Company received CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx®. These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark. This comes shortly after the Company acquired three 510(k) clearances from the U.S. Food & Drug Administration (FDA). Biotech’s are among the most explosive stocks in penny stocks and BIEL has a significant gap to fill from $0.07 highs of February 2021. The stock has a large investor following that will buy in significantly as soon as BIEL starts running northbound i earnest.
There is a lot going on at BioElectronics; according to the July 22 update the Conapny has completed and undertaken additional clinical research and has received the initial stocking purchase order from its distribution partner, Stada. BIEL recently completed a randomized, double-blind, placebo-controlled (RCT) study on providing pain relief and improving functionality for dogs suffering from osteoarthritis (OA). The owners of the dogs receiving the active device reported their dogs showed a 45% reduction in pain within 14 days compared to the dogs who received the placebo device. The Company is investigating how best to enter this multi-billion-dollar market in the near future. Also, a recent case study was published that used RecoveryRx medical device to help relieve phantom limb pain. It found that 67% of the users got pain relief after using this device. Also in a recently published paper, a RCT study of temporomandibular joint disorders (TMD) found that BIEL medical device, ActiPatch, provided better and longer pain relief than a combination of an NSAID and a commercially available muscle relaxant, Myospas. TMD affects approximately 5%–12% of the overall population and thus represents another potential market that we plan to explore.
(BIEL) is a leader in the field on non-invasive electroceutical medical devices. BioElectronics is the maker of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Therapy for postoperative pain and chronic wound care. The Company ActiPatch works by modulating the body’s nerve activity to dampen the pain perception, which reduces drug use. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications. In February 2017, BioElectronics announced that it received over-the-counter use market clearance from the US FDA for ActiPatch® for the adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel, and osteoarthritis of the knee.
The Company’s current 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 BioElectronics 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.
In February 2020, BioElectronics obtained a new 510(k) clearance from the U.S. FDA, granting overthe-counter marketing clearance for the drug-free ActiPatch® medical device, to cover all musculoskeletal pain complaints. This paves the way for new products to treat all medical claims for musculoskeletal pain, including in the back, knee, hips, wrists, elbow, and ankle.
In November 2020, the Company received the CE (Conformité Européenne) Mark for its ActiPatch® and RecoveryRx® Pulsed Shortwave Therapy (PSWT) medical devices. The ActiPatch is indicated for the treatment of general musculoskeletal/soft-tissue pain, while the RecoveryRx is indicated for the treatment of postoperative pain. These wearable devices can now be sold over the counter in 33 European Union (EU) countries, and many other non-EU countries like Australia that recognize the CE mark. The certification for the CE mark is valid until May 2024, and the Company’s updated quality management system will ensure prompt recertification.
BioElectronics has focused attention on international customers to expand its distributions and sales. The Company has established distribution agreements with distributors in the United Kingdom, Sweden, Southeast Asia, South Africa, Australia, Spain, Kuwait, and Italy. In November 2020, the Company announced the execution of a commercial partnership agreement with Scott Specialties Inc. (http://scottspecialties.com) to bring their innovative pain management devices to the retail consumer marketplace under the DonJoy® (DJO www.djoglobal.com)
The commercial partnership will leverage the Actipatch’s broad indications for use and offer active-passive treatment combination products to treat pain, increase physical functionality and improve overall quality of life. The new products will be marketed under DJO’s DonJoy Advantage (DJA) line of orthopedic appliances and sold as an EME Knee Wrap and an EME Back Wrap, “powered by Actipatch”.