FDA Status

BioElectronics Announces FDA Market Clearance for Its Non-Opioid Postoperative Pain Therapy

FREDERICK, MD, July 01, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce 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.

Physicians are discarding opioid-centric pain management, instead focusing on a multimodal approach of two or more analgesic therapies to decrease the use of opioids and to achieve more effective pain control [1]. Currently, less than 50% of patients who undergo surgery report adequate postoperative pain relief [2]. RecoveryRx will be an ideal choice in reducing postoperative pain and exposure to long-term effects of opioid/NSAID therapy.

RecoveryRx is a superior, drug-free, safe therapy and will be available to the 15 million Americans who experience postoperative pain from 25 million surgeries, annually [3]. Additionally, debridement and negative vac therapy treatments among the 7 million chronic wound patients are a significant market opportunity for RecoveryRx therapy.

Andrew Whelan, President, expressed confidence in seizing the market opportunity: “We are delighted that the FDA has recognized the potential of RecoveryRx in transforming postoperative pain care. RecoveryRx, with its high degree of safety, excellent clinical evidence of effectiveness and exceptional cost-benefit, will become the standard of care.”

As a side note, the Company is preparing documentation for its ActiPatch® 510(k) application to seek expanded indications of treating general musculoskeletal pain and intends to file within the next few weeks.

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

References

[1] Stavros, G. Memtsoudis, “Association of Multimodal Pain Management Strategies with Perioperative Outcomes and Resource Utilization: A Population -based study,” Anesthesiology, vol. 28, no. 5, pp. 891-902, 2018.

[2] Chou, Roger et.al., “Guidelines on the Management of Postoperative Pain,” American Pain Society, vol. 17, no. 2, pp. 131-157, 2016.

[3] Steiner, Claudia A (AHRQ);, “Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014,” AHRQ, February 2018 (Revised). [Online]. Available: https://www.hcup-us.ahrq.gov/reports/statbriefs/sb223-Ambulatory-Inp

Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com

BioElectronics Responds to FDA’s 510(k) Additional Information Requests for its Musculoskeletal Pain Relief and Postoperative Pain Applications

FREDERICK, MD, April 23, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com announced that the Company has submitted its response to the U.S. Food and Drug Administration’s (FDA) request for additional information on its ActiPatch® 510(k) market clearance application for “treatment of musculoskeletal pain in women”. Additionally, the Company has requested a conference call with the FDA to seek clarification on additional information requested on the RecoveryRx® 510(k) market application for “treatment of postoperative pain”.

The FDA’s additional information requested on the musculoskeletal 510(k) was for the submission of women’s clinical performance data from the Company’s clinical studies on knee osteoarthritis, plantar fasciitis and low back pain. The nature of the request was focused on the clinical performance comparison between men and women to assess the Company’s assertion that ActiPatch more preferentially treats musculoskeletal pain in women than men. In addition to the data, the FDA requested an explanation on how the proposed analyses support the market clearance indication and precludes the need for any additional information.

Sree Koneru, Ph.D., VP Product Development, said, “The clinical data from all three studies clearly indicates that the ActiPatch treats musculoskeletal pain significantly better in women than men. We have provided a detailed explanation on how our existing data meets the FDA’s clinical performance data requirement, and that additional studies are not required. Given the FDA’s guidance on gender analysis in clinical studies, precedent for gender-specific approvals and development of least burdensome guidelines, we are looking forward to a favorable outcome of our responses by the FDA.”

The ActiPatch product is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually).

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
940.262.3584
pknopick@eandecommunications.com

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:

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.

Rettner, Rachel;, January 2018. [Online]. Available: https://www.scientificamerican.com/article/women-feel-pain-more-intensely/.

Serdarevic, mirsada et.al.;, “Gender differences in prescription opioid use,” Curr Opin Psychiatry. , vol. 30, no. 4, pp. 238-246, 2017.

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