Bioelectronics Corp (BIEL)

[Simpsonly]

To be fair and reasonable to FDA staff, the 2009 (+-) 510(k) submissions by BIEL for review and OTC Clearance portrayed ActiPatch efficacy based on the heat generated by the device. This was incorrect, as determined by FDA under lab examination and testing. Initially, an individual at BIEL stated FDA people were stupid. I disagreed stating they must have discovered something wrong in the submission or the science. We went toe to toe.

After a time, scientists with BIEL reassessed and resubmitted. ActiPatch was cleared for the foot and knee February 2017. All that took 8 years! Thank God for Drs. Richard Staelin and Sree Koneru!!!!