RE:Company Status ...From what I make of it the Canadian acceptance is not really a big deal, very small market and knight had the rights to Canadian sales anyway.
The big catalyst will come from initial US results, chances are if they get FDA approval they will be acquired in very little time (studies show most larger pharma's buy out earlier stage company's once its been de-risked ie. have gotten or are near approval for Phase 2 than they use their resources/channels to monetize the successful profuct. (I can easily see Philips or GE taking them out if they are starting to get more traction on sales).
I would tend to agree that they will ned to raise more money - hopefully, they can get the preliminary US study results to show its likely to get FDA acceptance along with more sales growth to warrant a higher secondary offering - I personally would look for them to start this process by Q1 2018.
I believe in the story just think it will take a little longer to develop itself than expected (as is usual for most early stage companies). I can still see them getting taken out at 3-5$/share but I think thats more within a ~2year timeframe.