CytoSorbents Corporation (CTSO)

[techxen]

Thanks for these observations and your insights. This confirms what I am seeing with the current FDA registration that is on file, that it is classified as a Class 2 device under PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES (same Title 21 that you quote below).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=427282&lpcd=FLD

The company has several data points/sources that they can bring into the discussions with the FDA including the St. Georg Asklepios Hospital study, the label expansions from the EU, REFRESH II data, TISORB (what little they have collected so far), CYTATION, and the new STAR registry. My guess is one of the reasons for the lack of updates on the FDA approval path is that they are getting all of these sources in a presentable case. From the remarks on the CC, they used the words "very soon" so I suspect we are getting closer to hearing what this approval path will look like. I am just thrilled that Dr. Deliargyris with his background and credentials is leading these discussions with the FDA.