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Sunday, September 25, 2022

BioElectronics Corp. (OTCPINK: BIEL) Heating Up as ActiPatch® and RecoveryRx® Gain Traction & Co Looks to Expand into New Markets

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. 

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BioElectronics Corp. (OTCPINK: 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. 

BioElectronics Pain Relief ProductsThe 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”. 

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BIEL

On July 22 BIEL announced via a Shareholder’s update that the Company has completed and undertaken additional clinical research and has received the initial stocking purchase order from its distribution partner, Stada.  The update is below: 

Richard Staelin, Ph.D.: Dear Shareholders, 

I would like to take this opportunity to discuss some new developments and their possible implications for the Company. Let me start by again stating our guiding principles, that is, our core capabilities are in innovation with pulsed shortwave therapy (PSWT) and manufacturing an affordable medical device. With this in mind, I would like to provide information on a few very promising new developments. 

Canine Osteoarthritis 

We 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. (Pain levels were measured via eight behavioral indicators.)  In addition, these treatment dogs exhibited increased range of motion while the placebo dogs showed no such increase. (A paper describing this study is in preparation for submission to a veterinary journal and will be posted on our website by the end of this month). 

These results have at least two major implications. First, canine OA is found in at least 80% of older dogs and represents a new market for BIEL with few good competitive options for dog owners. We plan to investigate how best to enter this multi-billion-dollar market in the near future.  Second, because we placed the device on the dog’s neck near the cervical spinal cord and not near the arthritic joint, it provides new evidence on how PSWT works. This latter knowledge is extremely important since it provides insights into coming up with new applications. 

Phantom Limb Pain 

A recent case study was published that used our RecoveryRx medical device to help relieve phantom limb pain. It found that 67% of the users got pain relief after using this device. This is particularly encouraging since all of these patients had tried multiple other therapies and failed to find any relief. The doctor who is leading this study plans to conduct a larger RCT study to further document possible relief. More details can be found at the following link.   

Temporomandibular Joint Disorder (TMD) 

In a recently published paper, a RCT study of temporomandibular joint disorders (TMD) found that our 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. More details about the study can be found at the following link.

New Distributor Agreement 

We have continued our efforts to expand our markets internationally. We recently signed an agreement with Stada, a leading manufacturer of high-quality pharmaceuticals, who will be distributing ActiPatch to augment their non-prescription consumer healthcare products. We are now in the process of meeting the demand for their first order. 

Summary 

The Company has continued to develop strong business partners with major marketing firms while also scanning the environment for new markets and opportunities. Conducting sound research and documenting new applications is part of our DNA and should provide the Company with a successful future.  Again, we thank our shareholders for their continued support and look forward to further announcements, both in terms of new research findings and new market opportunities. 

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Currently trading at a $19 million market valuation BIEL is an exciting story developing in small caps. 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. 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

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