CytoSorbents Corporation (CTSO)

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Can you cite any examples where post-hoc analysis directly lead to an FDA approval?

As for why Cytosorb might want a new generation device to also target endotoxins:
Sepsis is a run-away immune response. It is a cytokine storm, also known as cytokine cascade and hypercytokinemia, is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and white blood cells. Using a fire analogy, it is a conflagration that can result from a number of different ignition sources. One of the many is Gram negative bacteria, which has an outer membrane containing endotoxins. Endotoxins elicit strong immune response that can lead to sepsis. Spectral’s product targeted the removal of these endotoxins. So, it was targeting a very specific ignition source. The problem with that treatment approach is that sepsis/cytokine storm consists of “a positive feedback loop between cytokines and white blood cells.” That means once it hits a certain point the treatment of the initial ignition source is less critical than stopping the conflagration/cytokine storm that is now fueling itself. Spectral’s product could very well be effective at removing endotoxins, but the window of treatment between when the gram negative bacterial infection sets in and when the cytokine storm kicks in is probably very short and in the real word, the endotoxin removal treatment is not likely to be started within that window.

All that being said, the initial ignition source may be less critical, but it still needs to be addressed once the more critical cytokine storm is extinguished. That is where the need for Cytosorb XL come in to play. Like Cytosorb, it squashes the storm, but it also removes the endotoxins.