CytoSorbents Corporation (CTSO)

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There are a few reasons. First, the cardiac surgery population is more homogenous. One valve replacement surgery is likely to have the same type of potential complications and the same odds of complications as another one. While sepsis can be triggered by a wide variety of initial illnesses. It could be pneumonia, burn injury, bacterial infection, etc. The list goes on and on. Each of these has its own unique potential complications that could lead to death. Getting a homogenous trial population of the sepsis patients would have to be very selective. Selective means slow to enroll.

Second, the cardiac trial could have a primary endpoint of reduced organ failure or a composite endpoint of reduction in the incidents of some of the common complications. With sepsis, the primary endpoint would almost cetainly be 28 day all cause mortality. With the heterogeneous sepsis population, even if Cytosorb resolved the cytokine storm, the initial trigger could still lead to death. That would mean a very large trial would be needed to ensure that CytoSorb provided a survival benefit and the randomization didn't just happen to favor the either the treatment or control arms.

A large and long US sepsis trial will certainly happen, but the cardiac route is the fasted most economical way to initial US marketing approval.