Wow,

Please recall that the four hospital head-to-head study is a "proof of concept" study and that the subsequent larger clinical trial will "...be the basis for the FDA approval of the medical device."

Of course, the larger clinical trial will only be conducted if the four hospital head-to-head study produces statistically significant results. Equivocal results in the four hospital head-to-head study would be the worst possible outcome for Cardiogenic share holders.

Ante