They delayed the trial for funds. Till last Dec the focus was on filing CE mark application based on the successful trial.
However CE mark needs many prerequisites and one of them was mfg facility certification - there was a screw up in that process and it got delayed. In the meantime the CE rules are changing which delayed the application further.
So co decided to go with external application in US.
If this product was with any other company (such as RDHL) with more funds - the product would be in market and would be undergoing multiple trials. And would have been bought out.
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