07/01/2019 FDA Clearance Press Release for Biel's RecoveryRX
BioElectronics Announces FDA Market Clearance for Its Non-Opioid Postoperative Pain Therapy
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July 01, 2019 08:57 ET | Source: BioElectronics Corporation
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/statbrie...latory-Inp
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Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
BioElectronics Announces FDA Market Clearance for Its Non-Opioid Postoperative Pain Therapy
Email Print Friendly Share
July 01, 2019 08:57 ET | Source: BioElectronics Corporation
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/statbrie...latory-Inp
Email and ask to Sign Up for Shareholders Emails
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
