Replies to post #21320 on CytoSorbents Corporation (CTSO)

[techxen]

This should be a positive thing on a couple of fronts, first it is a medical device and second, it validates that the FDA is looking at the benefit of the removal of pro-inflammatory cytokines.

If you read the FDA document that TwoNE1 posted, there is an interesting tid bit in there that apparently CG noticed as well, having to do with one differentiating factor about the D2000 device. I reposted his comments below:


"Note the focus of this first EBP is on removal from whole blood plasma, so this may tie into the current therapeutic focus on using convalescent plasma from recovered COVID-19 patients. But the description regarding removal of cytokines to ameliorate cytokine storm very clearly applies to and describes CytoSorb. Obviously, with CytoSorb, separating plasma from whole blood is not necessary to filter cytokines -- CytoSorb has the advantage of effectively removing cytokines directly from whole blood.

This is a significant development by the FDA. Somebody had to be first out of the queue, and I expect we will see more EUAs for EBPs in the next 1-2 weeks. "FDA believes based on the totality of scientific evidence available, that the removal of pro-inflammatory cytokines may ameliorate cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit." Thus, perhaps CytoSorb and other similar devices (Baxter's oXiris?) will soon follow."