CytoSorbents Corporation (NASDAQ: CTSO) announced results from an independent patient-level matched analysis of real-world data showing that intraoperative use of its CytoSorb device was associated with a 37% relative reduction in severe bleeding among patients undergoing urgent coronary artery bypass grafting (CABG) surgery while on ticagrelor, a blood-thinning medication.

The findings were presented at the European Society of Cardiology Congress on August 29, 2026. The analysis included 587 patients undergoing urgent CABG surgery after recent ticagrelor exposure. Patients treated with CytoSorb (198) from the STAR-T Registry were compared with matched patients (389) who underwent surgery without the device.

The analysis showed a severe bleeding rate of 21.8% in the CytoSorb group versus 34.5% in controls (p=0.002). The number of patients needed to be treated to prevent one severe bleeding event was eight. The analysis also showed reductions in 24-hour chest tube drainage (p=0.039) and red blood cell transfusions (p=0.003). No serious device-related adverse events were reported.

CytoSorbents said it plans to include the new analysis as part of a De Novo submission to the U.S. Food and Drug Administration for DrugSorb-ATR, targeting early 2027. The company said the submission would increase the number of patients represented in its regulatory package to approximately 250.

The company also disclosed that it held two FDA Pre-Submission meetings covering separate regulatory pathways for DrugSorb-ATR — one for ticagrelor removal and one for direct oral anticoagulant (DOAC) removal, including apixaban and rivaroxaban, in urgent cardiac surgery patients.

CytoSorb is approved in the European Union. DrugSorb-ATR remains an investigational device in the United States and has not been approved or cleared by the FDA.