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Wednesday, June 29, 2022

BioElectronics Corp. (OTCPINK: BIEL) Powerful Reversal Brewing as Pain Management Pioneer Launches RecoveryRx into Mexico & Spain

BioElectronics Corp. (OTCPINK: BIEL) recently hit lows of $0.0005 and accumulation has begun in earnest in recent days in red overall markets. 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 $0.038 highs of February 2021. The stock has a large investor following that will buy in significantly as soon as BIEL makes a significant reversal. 

BIEL has been busy since executing the OEM agreement with KT Health in December; the Company is now working with their three major channel partners, i.e., KT Health and Scott Specialties in the OTC space, and Medi-Launch in the prescription medical market, to solidify new orders after strong initial product launches that took place in Q1 2021. The Company is also pushing forward on the international sales front. In addition to re-acquiring their CE mark (which allows the Company to sell in most international countries) in late 2020, it also obtained MDSAP certification in Q1 2021, which now allows for product distribution in Canada, Australia, and New Zealand. More recently BIEL’s distribution partner in Mexico received authorization from Mexican FDA (Cofepris), which allows for the importation of the RecoveryRx® device into Mexico. Novro Med S.A. de C.V. has contracted for the exclusive distribution rights for RecoveryRx® in Mexico and it is expected that they will receive their initial stocking order during the 2nd quarter, 2022.  The Company also entered into a distribution agreement with Madrid / Spain based PRIM Group for the distribution of its RecoveryRx device throughout Spain. As per latest filings BIEL is topping well over $100,000 a month in sales.  

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. 

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) 

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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”. 

In December 2020, BioElectronics executed an OEM agreement with KT Health, LLC to bring its innovative pain management devices to encompass retail and e-commerce distribution throughout North America, as well as additional key international markets. The agreement incorporates BioElectronics’ ActiPatch® technology into KT Health’s KT Recovery+® product line, being marketed and distributed under the proprietary trade name KT Recovery+ WAVETM . KT Health will leverage BioElectronics’ FDA 510(k) clearance to market, promote and distribute the devices for the treatment of general musculoskeletal pain. 

At the end of March, the Company reported its distribution partner in Mexico has received authorization from Mexican FDA (Cofepris), which allows for the importation of the RecoveryRx® device into Mexico. Novro Med S.A. de C.V. has contracted for the exclusive distribution rights for RecoveryRx® in Mexico.  It is expected that they will receive their initial stocking order during the 2nd quarter, 2022.  Novro Med S.A. de C.V. is managed by Global Tech an 18-year-old Company which imports, distributes, and markets medical devices and other disposable medical items in Mexico.  

More recently the Company entered into a distribution agreement with Madrid / Spain based PRIM Group for the distribution of its RecoveryRx device throughout Spain. PRIM Group is expected to provide sales, marketing, and distribution services throughout Spain for RecoveryRx. The RecoveryRx medical device is designed to provide drug-free relief of post-surgical pain.  RecoveryRx is a single use device designed to provide 720 hours of therapy.  RecoveryRx is both US FDA cleared, and CE marked. 

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Currently trading at a $13 million market valuation BIEL has been on a straight line drop from $0.0038 in early 2021 and is currently under accumulation after hitting new 52 week low of $0.0005. Like any penny stock BIEL is a lottery ticket and there are plenty of risks involved. Considering this stocks’ past, its current price levels (where it started before the 2021 run) and a large shareholder base who is looking to jump back in as soon as a bottom is established and the stock reverses northbound. The Company boasts a growing OTC product line including ActiPatch® Musculoskeletal Pain Therapy, Allay® Menstrual Pain Therapy, Smart Insole™ Heel Pain Therapy, and RecoveryRx® Post-operative and Chronic Wounds Therapy which is currently bringing in about $100,000 a month in revenues. As we wrote previously on BIEL; “These sales numbers not only document the Company’s strong growth, but also serve as objective evidence of effectiveness for the Company’s strategic repositioning as an OEM manufacturer. BIEL has a mammoth shareholder base; ready liquidity and a long history of breakout moves.” 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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