Another point to this that doesn't make sense is that Sport doesn't need human clinical trials to complete 510k but Mcnally puts that out there they are looking to pursue human clinical trials. That doesn't make sense unless a third party would like to get those done and collect that data to have on hand for initial commercial launch. It definitely would fit the bill as to what a JnJ, Medtronic, Stryker would like to do (and have the money to do it) prior to commercialization but a small company like Titan?
It sounds like they could do design freeze right now with what they have - 100% success rate so far - as well as performing the first ever SP Prostatectomy in the WORLD - why wait to freeze design unless........