Bioelectronics Corp (BIEL)

[srinsocal]

Thanks for your Personal Opinion...but the Facts don't support it

The FDA has Cleared ActiPatch for 3 Indications, that is a Fact, and two of those 3 are the coveted OTC Clearance.

The FDA said the Back 510k Clinical Trial showed a significant treatment effect in women and a mild treatment effect in men.

This gender gap in efficacy did not show up in the Knee or Foot Trial.

510Ks are required to be 'Substantially Equivalent' to their Predicate Device. The Back Trial shows Substantial Equivalency for women so BIEL will resubmit a 510k for female use and get to work on the cause for lower efficacy in male Back Pain.