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10.10.2016 14:30
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BioElectronics Comments on its U.S. FDA's OTC Market Clearance Application
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PR Newswire
FREDERICK, Md., Oct. 10, 2016
FREDERICK, Md., Oct. 10, 2016 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced disposable electroceutical devices, announced that on Monday, October 3rd, 2016 it met with senior management from the FDA's Division of Neurological and Physical Medicine Devices, including the Deputy Division Director, the Acting Branch Chief of the Physical Medicine and Neurotherapeutic Devices Branch, the three reviewers for the ActiPatch® Musculoskeletal Pain Therapy 51O(k) premarket notification, and the assigned statistician, to discuss the data requirements to support a musculoskeletal pain indication for the device.
In the 51O(k) premarket notification for the ActiPatch® Musculoskeletal Pain Therapy, we included our osteoarthritis of the knee and plantar fasciitis clinical studies, along with an explanation of the device's mechanism of action, to support the indication for musculoskeletal pain relief. The agency has requested clinical data from an additional anatomical application area. We are prepared to provide real world evidence showing use of the ActiPatch® for treatment of chronic back pain from our large UK chronic pain registry. The Agency is assessing whether the registry data, along with the two well controlled clinical studies mentioned above, would be sufficient to support a musculoskeletal pain indication, and FDA has defined certain criteria that it considers relevant to this assessment; we are preparing to submit the relevant information for the agency's review. The original UK Registry was published in Pain Management A UK registry study of the effectiveness of a new over-the-counter chronic pain therapy, Pain Manag. 2015 Nov; 5(6): 413-23, http://www.futuremedicine.com/doi/full/10.2217/PMT.15.35
We have data on 5,660 back pain users, further supported by new data from an Observational Study on 117 subjects who used the ActiPatch® therapy over a 6-month period.
"We are hopeful that the data will meet the Agency's acceptance criteria and will expedite over-the-counter market clearance for musculoskeletal pain relief," said Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics Corporation.
About BioElectronics Corporation
BioElectronics Corporation develops non-invasive electroceutical devices and is the maker of an industry leading family of disposable, drug-free, pain therapy devices: 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:
Grace Holdings
732 335 1152
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/bioelectronics-comments-on-its-us-fdas-otc-market-clearance-application-300341599.html
SOURCE BioElectronics Corporation
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