Results from CytoSorb Therapy in COVID-19 (CTC) Registry presented at 35th Annual Congress of the European Society of Intensive Care Medicine

The CTC registry captured outcomes data on 100 critically ill hyper-inflamed COVID-19 patients with severe acute respiratory distress syndrome (ARDS) and refractory respiratory failure who were treated with an "Enhanced Lung Rest" strategy using CytoSorb and extracorporeal membrane oxygenation (ECMO) at five major U.S. ECMO centers. ECMO helps to rest the lungs and avoid ventilator-induced lung injury (VILI) by pumping blood and conducting gas exchange outside of the body, and reducing or eliminating the need for mechanical ventilation. CytoSorb® is easily installed into the ECMO circuit and actively removes a broad range of cytokines and other inflammatory toxins from the bloodstream that can cause blood vessel injury and capillary leak syndrome – a key pathology in ARDS that results in pulmonary edema, severely compromised gas exchange, and unrelenting damage to the lungs. The goal of this "Enhanced Lung Rest" strategy is to allow the lungs to rest and heal, which we believe is the key to reversing ARDS, getting patients off of ECMO and mechanical ventilation, and ultimately to survive.

For the primary outcome of survival, in 100 patients treated with CytoSorb and ECMO at 5 U.S. centers, survival was 86% at 30 days and 74% at 90 days. For context, the International Extracorporeal Life Support Organization (ELSO) COVID-19 registry, reported survival of 52% at 90 days in the North American cohort (11/2/22, n=9,509). For the secondary analyses CytoSorb was initiated significantly earlier following ICU admission in survivors compared with non-survivors: 64 (34-151) vs. 151(44-260) hours, p=0.007. Compared to non-survivors, survivors had significantly lower levels of inflammatory mediators after 3 days of CytoSorb treatment, such as CRP: 6.9 (2.1-11.0) vs 9.5 (6.0-17.1) mg/dL, p=0.04, and ferritin: 743.0 (339.5-1237.0) vs 1,622.0 (986.0-3411.0) ng/mL, p=0.0002, and required less time on ECMO: 302 (161-932) vs. 630 (268-1187) hours, p=0.04. Among survivors, those where CytoSorb was initiated early before the median start time of equal or less than 86.7 hours after ICU admission, had a trend to improved survival (78% early vs 62% late, p=0.08) and significantly shorter average duration on ECMO (532.76 +/- 533.05 vs. 800.74 +/- 701.67 hours; p=0.021). Time on mechanical ventilation [167 (43-597) vs. 321 (67-909) hours, p=0.045] and time to ICU discharge [17 (10 – 40) vs. 36 (19 – 55) days, p=0.002] were also significantly reduced in patients treated earlier. Combined ECMO and CytoSorb treatment was performed with no device related adverse events reported by any of the centers.

CytoSorb was granted U.S. FDA Emergency Use Authorization (EUA) in April 2020 for use in adult, critically ill COVID-19 patients with imminent or confirmed respiratory failure to reduce cytokines and other inflammatory toxins that can cause hyperinflammation. Severe hyperinflammation is strongly correlated with more severe COVID-19 illness, need for mechanical ventilation, and risk of death.