38 Distributors? Is that a current number and, is it accurate? In approx 2010-2012, BIEL's website had a page listing approx 50 Distributors globally. I recall that not one of them in the EU could import and sell any ActiPatch devices, without a CE Mark. BIEL quickly obtained that CE Mark very quickly, but none of the Distributors did anything except Boots in England.
A year or so ago, the current CBO, CEO bungled the renewal process, leading to the laughable bookkeeping label "Deferred Sales" as 7 pallets of ActiPatch devices sat gathering dust at BIEL. The amount? $536K.
Then the second laughable label, $536K in substantive sales awaiting regulatory approval". That would be the CE Mark! Easy to understand why it is a sensitive issue now, we already have the 'BIEL CE Mark snafu T-Shirt'!
The attitude first time around was, "nah, we don't need it, we'll just ship the goods." No rules for Whelans. Right.