Published On: Fri, Dec 9th, 2016

Bioelectronics Corp (OTCMKTS:BIEL) Speaks On OTC Market Clearance Application

Bioelectronics Corp (OTCMKTS:BIEL) the maker of unique disposable electroceutical devices, reported that they met with senior management from the U.S. FDA’s segment of Neurological and Physical Medicine Devices, comprising the Deputy Division Director, Neurotherapeutic Devices Branch, and the Acting Branch Head of the Physical Medicine. It also included the 3 reviewers for the ActiPatch® 51O(k) premarket notification, and the reported statistician, to discuss the data needs to boost a musculoskeletal pain indication for firm’s device.

The highlights

In the 51O(k) notification for the ActiPatch®, Bioelectronics included knee osteoarthritis and plantar fasciitis clinical trials, along with a description of the device’s action mechanism, to back the indication for musculoskeletal pain respite. The agency has demanded clinical trial from an additional anatomical application region.

They are set to offer real world evidence displaying use of the ActiPatch® for cure of chronic back pain from their U.K. chronic pain registry. The entity is evaluating whether the registry information, along with the 2 well controlled clinical trials, would be sufficient to boost a musculoskeletal pain indication, and the U.S. FDA has detailed certain criteria that it thinks relevant to this evaluation. They are preparing to file the relevant information for the FDA review.

The first U.K. Registry was released in Pain Management A UK registry trial of the effectiveness of a new OTC chronic pain treatment, Pain Manag. Bioelectronics has data of as many as 5,660 back pain users, further advanced by new report from an Observational trial on 117 subjects who tried the ActiPatch® treatment over a 6-month period.

Ian Rawe, Ph.D., the Director of Clinical Research with BioElectronics, said that they are positive that the data will come at par with the agency’s acceptance criteria. As a result, it will expedite OTC market approval for musculoskeletal pain relief.

In the last trading session, the stock price of Bioelectronics closed flat at $0.00040.

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