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We anticipate being able to file the 510(k) application in 1-2 weeks, for market clearance for the indication for use “adjunctive relief of musculoskeletal pain”. Given recent timelines with the RecoveryRx application, we anticipate that the FDA will reach a decision in late September or early October of 2019. Obtaining the expanded clearance will allow BioElectronics to market and sell the ActiPatch for multiple musculoskeletal pain locations such as the back, neck, elbow, muscle etc.

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