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ActiPatch and plantar fasciitis

Discussion in 'Biomechanics, Sports and Foot orthoses' started by NewsBot, Mar 15, 2006.

  1. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
     
  2. Craig Payne

    Craig Payne Moderator

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  3. NewsBot

    NewsBot The Admin that posts the news.

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    This clinical trial has just been registered:

    ActiPatch Plantar Fasciitis Clinical Trial
     
  4. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Press Release:
    BioElectronics' Study on Plantar Fasciitis to be Published in The Journal of Foot and Ankle Surgery
    Establishes Effective Heel Pain Therapy
     
  5. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Pulsed Radiofrequency Electromagnetic Field Therapy: A Potential Novel Treatment of Plantar Fasciitis.
    Brook J, Dauphinee DM, Korpinen J, Rawe IM.
    J Foot Ankle Surg. 2012 Jan 30.
     
  6. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
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    Effect of Monophasic Pulsed Current on Heel Pain and Functional Activities caused by Plantar Fasciitis.
    Alotaibi AK, Petrofsky JS, Daher NS, Lohman E, Laymon M, Syed HM
    Med Sci Monit. 2015 Mar 20;21:833-9. doi: 10.12659/MSM.891229.
     
  7. NewsBot

    NewsBot The Admin that posts the news.

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    Press Release:
    BioElectronics Files FDA Application for Treatment of Musculoskeletal Pain
    July 12, 2018, 08:30:00 AM EDT

    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
     
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