Yeah, in general, the first device of a class has fairly serious testing requirements. I'm not at all sure if PLC's patent estate gives them any hope of collecting royalties should someone implement the idea by adding an extra nurse (You might want to do this despite the outsize cost just for the effectiveness) (But I think it does).
With the Italian results being so dramatic, you could plan a fairly small pivotal US study, which saves money. There were probably individuals at that conference who could swing that much personally. But that would still leave PLC hopelessly backward in US selling muscle. So best hope is still a big friend to take over the project.
Actually, I think the best hope is that the device actually cuts the incidence of CIN and patients around the world (whether in Europe or the US) suffer less damage to their kidneys. My father had kidney damage due to contrast injected for a procedure. It prevented him from having future tests with contrast that might have prolonged his life. CIN is very dangerous and I hope this device works and saves lives. That's my best hope for this company.