Replies to post #2863 on CytoSorbents Corporation (CTSO)

[crookedneck]

The point is as I previously mentioned, that there has only been one other study close to using a similar device that CTSO has and thus the following:

Nothing like trying to muddy the waters with studies that designed to look at treating sepsis in pigs and other in vitro studies that is like comparing apples to oranges. The only study that is revelant is the ARDS study, which further demonstrates that CTSO is on the verge of something very big with comparable survival rates as it should!

So let's just be clear CTSO has developed and demonstrated by getting CE approval that it has a device with a high probability of 86% survival increase based on the study from Japan that is most similar to CTSO. Other studies that are in vitro, that are unlike CTSO's cytokine filtration system and studies regarding sepsis in pigs are completely irrelevant to what CTSO is working on.

On the other hand the Japanese study which is relevant further proves exactly what CTSO has and what it can do! After reviewing this info I feel very confident that CTSO will show similar survival rates and be on their way to being the FIRST to bring this life saving technology to market.

It will be clear soon enough and there will be no need for me to keep reminding you of what CTSO has and what we can expect as far as survival rates based on that similar study.

Plus the statement of yours on that .01 prediction is clearly based on your wishes and objective, but even you know that is completely ridiculous! Scare tactics of this magnitude clearly define ones motives towards this company and the fear of what they really may have!

There is little doubt of CTSO's future success imho and this will be revealed soon enough to completely disprove all your conjecture to date. This I am sure of and others will realize this too soon enough!!!

[ping_pow_princess]

Wouldn’t the Notified Body have to approve the labeling on the product, in this case, cytokine filter? And you can only claim something if it is backed up by a study? Dr Chan stated in the past, "The goal of the therapy is to reduce cytokine storm and to break the cytokine cascade since cytokines lead to the production of more cytokines." , " Nothing exists except supportive therapy to treat these patients and especially nothing has been approved to treat cytokine storm." and "To our knowledge, this is the largest such trial with a device specifically focused on cytokine reduction."

I am not aware of any other product that can be used to target the cytokine storm directly. Nor a technology that is capable of handling this storm based on what CTSO has compared to others. It is broad-spectrum solution that removes many different cytokines simultaneously (middle molecular weight between the 10 to 50 kDa range) and is self-regulating ( removes substances in relation to their circulating concentrations). Dr Chan has stated that it has massive capacity (7 football fields length), no separation of blood as the blood comes in direct contact with their polymer beads and in the six-hour procedure of continuous blood pumping through Cytosorb, it can treat 20 to 30 times a patient’s total blood volume.

If you look at a comparable -- Fresenius’s Ultraflux EMiC 2 which is CE Marked (pic on page 4), it is labeled as an ""enhanced middle molecule clearance" membrane" and optimized middle molecule removal in patients with high bleeding risk. For patients with "High concentration of myoglobin due to rhabdomyolysis" and "High concentration of cytokines, interleukins and other factors elevated in septic patients (improved outcome has not yet been proven)". It comes as part of a kit. The membrane cut-off is at 40 kDa, it has 1.8 m² surface area and blood filling volume of 130 mL. From their trial, "The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each."

http://fmc-ag.se/files/Brochure_Ci-Ca_EMiC2.pdf