CytoSorbents Corporation (CTSO)

[techxen]

Could be the reason for the uptick in volume and price appreciation today.

"CTSO preannounced expected Q4 revenue of ~$4.6M including
product sales of ~$4.2M, implying new records for both. This also
implies product sales growth of 58% on a yoy basis and about 20%
compared to the $3.5M posted in Q3 the previous record high. We
have since made upward adjustments to our Q4 numbers, as well as
to our forecasted product sales in the out-years in our model.
IDE for REFRESH II was approved by FDA in December. The multicenter,
randomized, controlled U.S. study is expected to enroll up to
400 patients which are undergoing elective open heart surgery for
valve replacement or aortic reconstruction with hypothermic cardiac
arrest. As we had hoped, the primary endpoint, reduction of acute
kidney injury (AKI) as measured by KDIGO, is outcomes-based. We
had a chance to sit down with Dr. Chan earlier this week in San
Francisco shortly following his presentation at the Biotech
Showcase. Most of our questions revolved around REFRESH II
given that it currently represents the potential gateway for CytoSorb
to enter the U.S. market. We came away feeling confident in the
robustness of the trial design and, by extension, the potential
commercial appeal of CytoSorb if the trial is successful."