FDA Status

BioElectronics Announces FDA Market Clearance Update

FREDERICK, MD. November 27, 2018— BioElectronics Corporation (OTC Pink: BIEL), the maker of non-invasive electroceutical devices, announced that the U.S. Food & Drug Administration (FDA) declined the company’s 510(k) submission for ActiPatch®, intended for seeking expanded over-the-counter (OTC) indications for the treatment of musculoskeletal pain. In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a mild treatment effect in men. Since gender differences in treatment effects were not identified in prior ActiPatch clinical studies (knee and plantar fasciitis pain), the FDA concluded that the clinical evidence in the current 510(k) application was “not substantially equivalent” to the prior evidence.

The medical community acknowledges that there are gender differences in responses to pain therapies [1], and importantly, that women experience pain more intensely than men [2]. Moreover, women are at a greater risk of using opioids than men to combat chronic pain [3]. Given the risks inherent with opioid use, as well as limited efficacy of other pharmacotherapy options such as NSAID’s and topicals, there is a dire need for a safe and effective non-pharmacological pain therapy like ActiPatch. Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men. The company intends to leverage these findings and resubmit the 510(k) application for a more specific indication: relief of musculoskeletal pain for women. Our sales data are compatible with the observation that women get substantial relief in that about 70% of our sales are to women.

Sree Koneru, VP of Product Development, expressed confidence in this strategy, both from a regulatory and marketability perspective. “We are also diligently proceeding with 510(k) applications for US market clearance of postoperative pain (RecoveryRx®) and menstrual pain (Allay®)”, he added.

About BioElectronics Corporation
BioElectronics Corporation 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; and HealFast® Therapy for dogs, cats and horses. For more information, please visit www.bielcorp.com.

Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com

References

[1] Bartley, E. J. et.al.;, “Sex differences in pain: a brief review of clinical and experimental findings,” Br J Anaesth. , vol. 111, no. 1, pp. 52-58, 2013.
[2] Rettner, Rachel;, January 2018. [Online]. Available: https://www.scientificamerican.com/article/women-feel-pain-more-intensely/.
[3] Serdarevic, mirsada et.al.;, “Gender differences in prescription opioid use,” Curr Opin Psychiatry. , vol. 30, no. 4, pp. 238-246, 2017.

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BioElectronics Files FDA Application for Treatment of Musculoskeletal Pain

FREDERICK, MD, July 12, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch® was filed today with the U.S. Food and Drug Administration (FDA). The market clearance requested was “over-the-counter adjunctive use in the treatment of musculoskeletal pain”.

While ActiPatch is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 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. Full details about the study can be found at the NIH’s clinical trials listing page: (NIH Back Pain study link).

The 510(k) was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professor, Duke University, Ian Rawe, Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics. Dr. Koneru, who spearheaded the 510(k) effort, said, “We are confident with the strength of our data and overall application. Given the FDA’s prior knowledge of the data and prior clearances, we believe that the 510(k) will be processed in a timely manner.”

Keith Nalepka, VP of Sales/Marketing, remarked on the market opportunity: “An expanded market clearance will make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are suffering with musculoskeletal pain.”

About BioElectronics Corporation

BioElectronics Corporation 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. For more information, please visit www.tryactipatch.com

Contact:
Paul Knopick
9402623584
pknopick@eandecommunications.com

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application

FREDERICK, MD , May 11, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com is pleased to report on the outcome of its Pre-Submission meeting on May 9th, 2018 with the US Food and Drug Administration (US FDA). 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.

Upon reviewing pre-submission information on the ActiPatch® back-pain study (https://clinicaltrials.gov/ct2/show/NCT03240146), the FDA provided positive feedback on the clinical results, and guidance on a 510(k) submission to obtain expanded market clearance for over-the-counter (OTC) treatment of musculoskeletal pain. This would make ActiPatch available as a drug-free, safe, pain relief option for the 126 million Americans (one in two adults) who are 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.

The company 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 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.

An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.

About BioElectronics Corporation

BioElectronics Corporation 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. For more information, please visit www.bielcorp.com
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com

BioElectronics Corporation Announces US FDA OTC Clearances For Drug-free ActiPatch® Musculoskeletal Pain Therapy

 FREDERICK, MD, USA, February 5, 2017 — BioElectronics Corporation (OTC Pink: BIEL), the maker of wearable pain therapy devices, announced today that it has received over-the-counter use market clearance from the US FDA for ActiPatch® for the adjunctive treatment of musculoskeletal pain related to (1) plantar fasciitis of the heel; and (2) osteoarthritis of the knee.

BioElectronics is an electroceutical company that develops wearable, neuromodulation devices to safely mitigate neurological diseases and improve quality of life. Our innovative pulsed shortwave therapy technology (PSWT) that uses low power pulsed electromagnetic fields regulate electrical activity of the nervous system. The neuromodulation basis of PSWT presents significant opportunities for BioElectronics to develop optimized technology for diabetic neuropathy, postoperative surgery, chronic wounds, and other applications.

Our 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 our 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 for $30.00 retail. Most users obtain relief with only 8 hours per day of use, so the device will generally last several months, depending on use. ActiPatch Provides:

• Impressive Efficacy
• No harmful side effects
• A 50% Reduction in Medication Use, including opioids
• Exceptional Consumer Acceptance
• Demonstrated Marketability
• An adjunctive or alternative therapy to pain killers, including narcotics.

About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: For more information, please visit www.bielcorp.com.

How to Order
Go to www.tryactipatch.com to order yours today.

Contact:
BioElectronics Corporation
301-874-4980
info@bielcorp.com
4539 Metropolitan Court
Frederick, MD 21704