SPY441.40-4.34 -0.97%
DIA345.64-1.80 -0.52%
IXIC15,043.97-137.96 -0.91%

Topline Results From CytoSorbents' U.S. CTC Multicenter Registry Demonstrate High Survival Using CytoSorb In Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation

CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced that topline results from its

Benzinga · 09/01/2021 07:10

CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced that topline results from its CytoSorb Therapy in COVID-19 (CTC) multicenter registry were presented at the 40th International Symposium on Intensive Care and Emergency Medicine (ISICEM 2021) in Brussels, Belgium yesterday.  The CTC Registry included 52 consecutive critically ill COVID-19 patients with refractory acute respiratory distress syndrome (ARDS) on life support with ECMO and CytoSorb enrolled at 5 U.S. medical centers under FDA Emergency Use Authorization (EUA).  The primary outcome of 90-day ICU mortality was 27% in the CTC Registry.  For context, the 90-day mortality in the North American cohort of the international Extracorporeal Life Support Organization (ELSO) COVID-19 ECMO Registry that includes more than 4,600 adult patients was 50%1.  Importantly, all 5 centers participating in the CTC registry reported that CytoSorb was easily integrated in the ECMO circuit and well-tolerated, with no unanticipated device-related adverse events.

Topline Results from U.S. CTC Registry Show High Survival using CytoSorb® in Critically Ill COVID-19 Patients on ECMO

 CytoSorb received FDA Emergency Use Authorization in April 2020 for use in critically ill COVID-19 patients, 18 years of age or older with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels, and can be used with a wide range of blood pumps, including ECMO.  ECMO is a machine that pumps and oxygenates blood outside of the body, reducing the dependence on the lungs for gas exchange, and allowing mechanical ventilator settings to be lowered to prevent ventilator-induced lung injury. The CTC Registry inclusion criteria required that CytoSorb use adhere strictly to the patient selection criteria and device use guidelines outlined by the EUA, including standardized training and treatment schedules with CytoSorb, thereby providing high fidelity evidence in a relatively uniform study population.  Highlights from the presentation included:

  • Overall demographics and comorbidities of the CTC cohort were comparable to the ELSO Registry cohort with the exception of higher rates of obesity in the U.S. CTC cohort, a recognized risk factor for death in COVID-19
  • Primary outcome of 90-day ICU mortality was 26.9% from the initiation of CytoSorb treatment, well below the 50% reported in the North American cohort of the ELSO registry
  • Rates of ICU discharge and recovery exceeded ICU mortality rates throughout the follow-up period. All patients discharged alive from the ICU also survived to hospital discharge
  • CytoSorb treatment led to a decrease in elevated baseline inflammatory biomarkers
  • Survival was associated with earlier initiation of CytoSorb therapy, lower baseline D-dimer levels, and a lower baseline Sequential Organ Failure Assessment (SOFA) score
  • Very high baseline D-dimer levels (breakdown products of blood clots) were associated with a potential increased risk of death by logistic regression analysis. This is consistent with published literature on D-dimers and the associated increased risk of severe disease and death in COVID-19 patients, presumably due to the consequences of high blood clot burden, including respiratory failure caused by pulmonary emboli, and diffuse tissue and vital organ ischemic injury caused by thrombotic microangiopathy
  • CytoSorb demonstrated no unanticipated device-related adverse events