CytoSorbents Corporation (CTSO)

[orangecat]

From early on in the REFRESH trial the company has stated the goal was, in addition to demonstrating safety, to identify the types of procedures and patients that end up with high plasma-free hemoglobin. This is just a 46 patient study though. If just half of the procedures did not result in high hemoglobin levels we are talking about comparing less than a dozen treated patients to less than a dozen control patients. I think it would be hard to claim blockbuster results with such a small sample. I do like that Chan did also point out that the study did demonstrate the removal of inflammatory mediators though.

From the Q4 call on the topic of REFRESH 1:
One, demonstrated the safety of the therapy; Two, we identified surgical procedures that were in this complex cardiac surgery group where patients were identified as having the highest levels of plasma-free hemoglobin and that is very important because that will allow us to enrich the next trial for those at greatest risk of organ injury due to these high levels of plasma-free hemoglobin thereby potentially allowing our trial to be more focused, smaller, less expensive and potentially executed faster. And last but not least, we demonstrated that CytoSorb removes key inflammatory mediators during the treatment period.