I'll post this here as well for all the misinformed CTSO investors on their board. They deleted the post, no reply no nothing? Hmm, I wonder why?
Oh where do I start here...
First off, I do like Cytosorbs technology and do believe it will be instrumental in the fight against sepsis and other disorders. You all are very misinformed as to what Spectral has on the table as are many investors hence their share price at the moment. This is 100% managements fault but I don't believe they are concerned as they are aware of what they have and that there are big name pharma companies looking at purchasing as they have 22 employees where as large pharma companies have large inside sales forces inside hospitals already to effectively market their product; the exact thing spectral needs. This is also the reason PMX hasn't been used in Canada, they have a spineless government which relies on US FDA approval as a baseline for its drugs and medical devices. Without US FDA approval the Canadian health care system being paid for by the government will not cover such a treatment.
To start, when you compare CTSO to spectral you're comparing a company with one very small Trial to another company who is 5 years ahead which has completed a very large, double blinded FDA PMA study. Spectral looked great at the stage CTSO is at currently and there was evidence of extreme efficacy with little to no known adverse safety effects.
This study (Euphrates) was underpowered from the start, it is believed that the study was largely done this way to see where EXACTLY PMX was effective because like any drug or device treatment there are cases where people are simply too far gone to respond to treatment. Why do I say this? Simple, look at the 21st century cures act that was brought in which mandates the FDA to look differently at devices or drugs in which no treatment exists or there is an extreme need for where we all know Sepsis falls in that category. It also mandates them to take a different approach when looking at data including looking at real world data in other studies as well as subgroup analysis which if you look into the details on Spectral's trial they achieved extreme efficacy in the subgroups where EAA was above 0.6 and below 0.9. Furthermore for the group which was above 0.9 the endotoxin levels were above 50 iu and the absorption capacity of each cartridge of PMX was 12.5 iu meaning that in the most sick patients we only removed less than 50% of their endotoxin which indicates the study was underpowered as spectral did achieve up to a 42% risk reduction at 28 days (21% mortality versus 42% mortality) in a subgroup where arterial pressure was maintained in both arms and where there was no culterable bacteria present (antibiotics not gonna help you there). One needs to ask, if the trial allowed for 3 or 4 columns to be used on these sicker patients, could we have had the same results as the subgroup?? This is exactly the type of data the FDA is going to start looking at. Precision medicine is the future and the 21st century cures act clearly outlines it's happening now.
In respect to the SAM pump, spectral does not need this for the PMX treatment, a dialysis pump works fine but they have refined the average dialysis pump making it more economical, more effective, less bulky and easier to use.
As far as Spectral's EAA diagnostic which is approved in Canada and the US, this is the holy grail and it will be used in many different cases other than sepsis. The market for this diagnostic alone is huge! Imagine being a doctor with an approved treatment available and you now have the data to show you when exactly it is effective and also the instrument/test to show you where exactly you are in that spectrum and if it's working.
Also to note is the fact that there is a Taiwanese study going on right now starting treatment sooner with EAA levels at 0.5 vs 0.6. This doesn't seem like much of a difference but when you look at it in detail, you are 3 times as likely to die with EAA levels of 0.6 than 0.5.
Someone on this board said that PMX cannot treat patients who actually have sepsis. I'm sorry but you are sadly mistaken. With the Euphrates trial look at what MODS 9 means. (Multiple organ disfunction score) multiple organs were required to be not operating as they should or failing to receive treatment, this includes the subgroup where there was success listed above. These organs were failing as a direct result of sepsis and these patients were going into septic shock (multiple organs failing, health drastically deteriorating).
Finally, the Euphrates Trial was done at some of the top hospitals in the US where the SOC (standard of care) is above average compared to your national average across the USA. This also impacted Spectral's absolute reduction and primary end point in the Euphrates Trial with a baseline mortality rate of 42%. They also were using the sham cartridge PLUS EAA which is not the current standard of care. One must ask, without EAA being used and in an average hospital would that baseline mortality be much higher than 42% as it has been in previous studies. Food for thought.
Toray and Birch hill own over 70 million shares and have not sold anything. Now approval isn't a certainty but with the EAA, Sam Pump, 21st century cures act, the fact there is no cure and the closest one is 5 years away, also the "smart money" not going anywhere. You have to ask yourself the following question:
If you were the FDA and you have hundreds of thousands dying each year from a disease which there is no cure or viable approved treatment for do you wait 5 years and let countless more die or do you approve or at the very least conditionally approve a treatment which is approved in many countries around the globe, has been used over 170,000 times effectively and also has minimal adverse safety effects through the countless number of trials conducted?
I'm very confident it will go the right direction but that's just my opinion.