Bioelectronics Corp (OTCMKTS:BIEL), as we predicted, has received pre-submission FDA approval for its ActiPatch back pain product for muscoskeletal pain. BIEL is up over 120% over the last month. Over the last few months, the stock went from triple penny – $0.008 – to now sitting at $0.033. Stated in an earlier article, the full FDA approval looks promising as the patch does not chemically alter the body and these products typically do not fail to reach wide-scale adoption. This is good news for BIEL who could see more rips in their future.
According to BIEL, approval on this level make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans suffering with some form of musculoskeletal pain. While ActiPatch is already FDA cleared for treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (1 million annually), expanded market clearance would allow additional products for the back (42 million), neck (19 million), hip (9 million), shoulder (11 million), carpal tunnel (12 million) and many other musculoskeletal complaints. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance,” said Dr. Sree Koneru, VP of Operations.
Bioelectronics Corp (OTCMKTS:BIEL) is 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.
According to the company, BIEL is a development-stage company. The Company is a developer, marketer, and manufacturer of non-invasive electroceutical medical devices. Its devices consist of a microchip, battery, and antenna, and use therapies of heat and electric restoration of the body’s injured cells. Its devices are used to treat acute and chronic pain, as well as to promote wound healing. Its products include, as mentioned above, ActiPatch for Musculoskeletal Pain, Smart Insole for Foot Care, Allay for Menstrual Pain, RecoveryRx for Chronic Wounds and Postoperative Recovery, and HealFast for cats, dogs and horses. ActiPatch is a pain therapy for a range of common conditions causing pain, including osteoarthritis, rheumatoid arthritis and fibromyalgia. Its Smart Insole consists of Electro-Pulse micro medical devices that are embedded in heel gel inserts. Its Allay is a micro medical device that uses Electromagnetic Pulse Therapy to reduce menstrual pain and discomfort.
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A second meeting will take place on May 29th, 2018 to seek expanded indications for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device. BioElectronics currently has a prescription-only clearance for the treatment of edema following blepharoplasty (eye-lid corrective surgery).
This technology has some serious appeal for a very common ailment. The ActiPatch’s electromagnetic signal pulses 1,000 times per second to stimulate neuromodulation of the afferent nerves to dampen the brains perception of pain. The product’s pulsed signal rate prevents adaption to allow long-term use. ActiPatch therapy extended pain relief improves sleep, physical activity and overall quality of life. According to the company, ActiPatch provides 720 hours with on/off capability, is 100% safe and can be used with any medications. Obviously, if the patch is 100% safe is still to be determined.
Bioelectronics Corp (OTCMKTS: BIEL) is riding this news up more than 15% for the day. BIEL has a market cap of $61.46M and outstanding shares of 18.08B. As stated above, BIEL could see another run and test more highs as this product reaches full-scale approval. This is a very large market and investors should take notice. This is an exciting story and we will be writing updates soon. For continuing coverage on shares of $BIEL stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $BIEL, either long or short, and we have not been compensated for this article.