BioElectronics Corp. (OTCPINK: BIEL) saw a boost in early February after the Company announced it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its drug-free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.” The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints.
Full body clearance for BIEL flagship the Actipatch is a game changer for BioElectronics and is a harbinger of many good things to come here. AW would be very proud if he could see what Kelly Whelan has been able to accomplish in a relatively short time.
BioElectronics Corp. (OTCPINK: BIEL) bills itself as 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.
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.
According to BIEL corporate website:
Advantages of ActiPatch®
- EFFECTIVE: Clinically proven pain and inflammation relief at the source.
- LONG LASTING: 720 hours of action with On/Off switch.
- SAFE: Drug and ingredient-free and is safe for continuous use with no adverse effects. Safe for diabetics, arthritics, bedridden and the elderly and can be used with any medication.
The ActiPatch® Provides 720 Hours of Pain Relief Therapy
This therapy is a significant opportunity and presented by one of the most common human ailments, namely, musculoskeletal complaints. This is especially true regarding the substantial market for treating back pain. Additional product opportunities exist to treat sore necks, knees, tennis elbow, heels, and wrist pain.
Longtime CEO AJ Whelan died in October. Mr. Whelan founded BioElectronics Corporation to bring to market a breakthrough drug-free medical device, ActiPatch Therapy. ActiPatch is an analgesic device that also reduces inflammation and speeds healing. Since its founding, Whelan successfully earned several Food & Drug Administration clearances and medical device approvals around the world. Under Whelan’s leadership the Company earned FDA approval for reduction of edema following blepharoplasty, for osteoarthritis of the knee, and for relief of plantar fasciitis. It was his daughter Kelly Whelan who took it to the next level and was able to secure full body FDA clearance.
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On February 3 BIEL announced it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the-counter marketing clearance was granted for the drug-free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.” The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, Vice President Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain, for instance, in the back, knee, hips, wrists, elbow, and ankle.”
— BioElectronics Corp (@BielCorp) February 5, 2020
Kelly Whelan, President of BioElectronics, stated: “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.”
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Currently trading at a $18 million market valuation *based on 22.9b OS as of February 7; BIEL did $580k in sales for the 9 months ended September 30, 2019. 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 just recently received full body clearance from the U.S. Food and Drug Administration (FDA) for its drug-free ActiPatch® medical device. This represents a game changer for BioElectronics and opens up a lot of doors for the Company. There is huge demand for BIEL here, more than most penny stocks could dream of, if they can reach an agreement with debt holders big things could happen here. 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