Bioelectronics Corp (BIEL)

[seven-up]

Bioelectronics Corp (OTCMKTS:BIEL) Looks for New Energy Following FDA Meeting
By James Hudson

Jun 7 at 5:03 PM

As we have noted, it’s important to take frequent readings on the action in Bioelectronics Corp (OTCMKTS:BIEL), which has been one of the most spectacular momentum movers over the past on the OTC. Shares of the stock have been consolidating following a 400% rip to close out the month of April. It also managed to close last week on a strong note helped along by a catalyst central to its narrative.
Specifically, the company just offered up a report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). According to its most recent release, “the FDA’s Pre-Submission Program is designed to organize and give guidance and feedback on clinical data and what regulatory pathway should be followed to get market clearance. The focus of the May 9 pre-submission meeting was in discussing the FDA’s feedback on the clinical outcomes and statistical techniques used in reporting the back-pain study.“

Bioelectronics Corp (OTCMKTS:BIEL) develops, manufactures, markets and sells consumer medical electronic devices that have both a high efficacy and safety profile for acute and chronic pain. Along with the added benefit of an unmatched cost/benefit ratio, the Company’s innovative, miniaturized technology contains an embedded microchip and battery that deliver pulsed electromagnetic field energy, a clinically proven and widely accepted anti-inflammatory and pain relief therapy that has only been possible to obtain from large, facility-based equipment.

BioElectronics markets and sells its current products under the brand names ActiPatch Musculoskeletal Pain Relief, Allay Menstrual Pain Therapy, RecoveryRx Chronic Wounds and Postoperative Recovery, and HealFast Therapy for cats, dogs and horses.

The company is headquartered in Frederick, Maryland, USA. BioElectronics is changing the way people heal around the world.

According to company materials, “Pain has a significant impact on quality of life and with our expanding international presence we are touching the lives of individuals suffering from pain and edema worldwide. Our vision is to provide our highly effective and safe technological solution to pain. We received the “2009 Wall Street Journal Technology Innovation Awards” with our unique anti-inflammatory technology that reduces pain and edema. This technology is the platform for everything that we do. Our current strategic vision is to develop a number of strong brands that build upon our technological platform. Currently, the main applications are aimed at the OTC markets for back pain, knee pain and menstrual pain. We hope to introduce our technology to new markets and additional countries in the near future.”



As noted by the company, it was represented by their clinical R&D team comprising: Sree Koneru, Ph.D., VP Product Development, Ian Rawe, Director Clinical Research of BioElectronics, Kenneth McLeod, Ph.D. Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D. Professor Duke University.

Dr. Koneru, who apparently led the discussion, expressed confidence in the FDA’s constructive feedback. “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.”, he said.

The chart shows just under 140% piled on for shareholders of the listing during the trailing month. In addition, the company has registered increased average transaction volume recently, with the past month seeing just shy of 180% beyond what we have been seeing over the larger time frame.

s. BIEL is pulling in trailing 12-month revenues of $1.8M. In addition, the company is seeing major top-line growth, with y/y quarterly revenues growing at 15.8%. This is an exciting story, and we look forward to a follow-up chapter as events transpire.

Disclosure: we hold no position in $BIEL, either long or short, and we have not been compensated for this article.


6/7/2018 6:00:04 PM 1141231