BioElectronics Corp. (OTCPINK: BIEL) is making a strong move up the charts in recent weeks on heavy trading as the Company reports it has received the 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).
This represents the latest in a series of recent wins for BioElectronics. The CE mark allows the Company to resume fulfilling substantial orders for existing international partners, and close pending deals that were contingent on the CE mark. BioElectronics has signed long term contracts with, and received initial stocking orders and cash deposits from, three major companies. These initial orders total more than 120,000 ActiPatch devices. The Company recently reported it already has 250+ Reps in the field selling RecoveryRX. BIEL operates in the booming chronic pain market which is larger than diabetes, heart disease, and cancer combined, with 20% of adults globally suffering from chronic pain. ActiPatch addresses the unmet need for 1.5 billion worldwide chronic pain sufferers.
BioElectronics is an electroceutical company that develops wearable, neuromodulation devices to safely mitigate neurological diseases and improve quality of life. The Company’s core capabilities are its deep knowledge and experience in Pulsed Short Wave Therapy (PSWT) technology which is the use of non-thermal, high-frequency electromagnetic fields for therapeutic purposes. 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 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. On July 1, 2019 the Company announced that it has received market clearance from the United States Food and Drug Administration (US FDA) for its RecoveryRx® medical device, for the treatment of postoperative pain. In February 2020, BioElectronics obtained a new 510(k) clearance from the U.S. FDA, granting over-the-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. The chronic pain market is larger than diabetes, heart disease, and cancer combined, with 20% of adults globally suffering from chronic pain. ActiPatch addresses the unmet need for 1.5 billion worldwide chronic pain sufferers.
The Company’s medical devices modulate the body’s nerve activity to dampen the pain perception, which reduces drug use. RecoveryRx will be an ideal choice in reducing postoperative pain and exposure to long-term effects of opioid/NSAID therapy. Ken McLeod, PhD. Director of Clinical Science and Engineering Research, Binghamton State University of New York, explains in a short video how the technology and ActiPatch works.
Management believes the technology has the potential to become the standard of care throughout the healthcare continuum across the OTC and healthcare markets. BioElectronics’ technology offers significant opportunities in menstrual pain, heel pain, migraine headaches, diabetic neuropathy, postoperative surgery, chronic wounds, bone growth stimulation, and other applications. BIEL plans to act as the original equipment manufacturer (OEM) which has allowed the Company to establish several new distributing relationships and develop new product offerings.
Recently BioElectronics executed a commercial partnership agreement with Scott Specialties Inc to bring their innovative pain management devices to the retail consumer healthcare marketplace under the DonJoy® Advantage product line. This commercial partnership leverages the ActiPatch’s broad indications for use and offer an active-passive treatment combination product 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”.
On November 12 BIEL announced it has 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.
BIEL is an exciting stock in small caps with a long history of big moves in recent years. Currently on the move northbound as the Company reports it has received the CE Mark for its ActiPatch® indicated for the treatment of general musculoskeletal/soft-tissue pain and RecoveryRx® Pulsed Shortwave Therapy (PSWT) indicated for the treatment of postoperative pain medical devices. 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). This represents the latest in a series of recent wins for BioElectronics. The CE mark allows the Company to resume fulfilling substantial orders for existing international partners, and close pending deals that were contingent on the CE mark. BioElectronics has signed long term contracts with, and received initial stocking orders and cash deposits from, three major companies. These initial orders total more than 120,000 ActiPatch devices. The Company recently reported it already has 250+ Reps in the field selling RecoveryRX. BIEL operates in the booming chronic pain market which is larger than diabetes, heart disease, and cancer combined, with 20% of adults globally suffering from chronic pain. ActiPatch addresses the unmet need for 1.5 billion worldwide chronic pain sufferers.
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