CytoSorbents Corporation (CTSO)

[stingman49]

Hi Gene,

Please see the response I sent to another shareholder. Feel free to repost it.

Dear....

Feel free to post this.




I think that you will need to get the perspective of a cardiac surgeon and an interventional cardiologist. Respectfully, the feedback is only partially correct.

For acute coronary syndrome (1.1 million cases a year in the US alone), the management is initially dual anti-platelet therapy, where everyone is getting aspirin and a P2Y12 platelet inhibitor. The choice then is Plavix (clopidogrel) or Brilinta (ticagrelor), or Effient (prasugrel). Plavix is a clearly inferior drug to ticagrelor on most clinical outcome measures including mortality, but because Plavix is generic and cheap, it is used widely in the U.S. But ticagrelor is also used widely (1/3 of the market). However, this is expected to change when ticagrelor goes off patent in 2024. In the meantime, ticagrelor was the only technically reversible P2Y12 platelet inhibitor (providing a greater level of safety), but they were never able to capitalize on this feature because there was no reversal agent. Now with CytoSorb, the question will be: why would an interventional cardiologist continue to prescribe Plavix (or prasugrel) when he knows these are irreversible platelet inhibitors, and that ~10% of his patients will not be eligible for PCI/stent and need emergency CABG and have a high risk of bleeding because of Plavix or prasugrel? We believe the availability of CytoSorb will eventually make ticagrelor the preferred agent for dual anti-platelet therapy in ACS. Also, the PLATO trial shows the risk of "major fatal/life-threatening" bleeding in cardiac surgery when you stop and allow washout of the drug for 1-7 days is still very high for both Plavix (clopidogrel) > Brilinta (ticagrelor); See Figure 2). https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s020lbl.pdf


For the Factor Xa inhbitors, Andexxa by Portola Pharma is the reversal agent. But dig deeper. It only works during the 2 hour infusion and then the effect wears off, it has a black box warning as being pro-coagulant (which you do not want in someone who just had a heart attack from a clot and has a new bypass grafts) and costs > $15K per dose. For GI bleeds, intracranial bleeds/strokes, and trauma, Andexxa is a good option. For cardiac surgery, CytoSorb is a much better option, IMO.

I hope this is helpful.

Best,
Phillip