CytoSorbents Data Shows 37% Bleeding Reduction, FDA Path Progress

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โดย PR Newswire·US·Read original
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CytoSorbents Corporation announced new real-world data showing a significant 37% relative reduction in severe bleeding with its CytoSorb device in urgent coronary artery bypass grafting patients on the blood thinner ticagrelor, alongside progress in FDA pre-submission meetings for its DrugSorb-ATR system. The patient-level matched analysis, presented at the European Society of Cardiology Congress 2026, compared 198 CytoSorb-treated patients from the STAR-T Registry with 389 matched controls, finding severe bleeding in 21.8% versus 34.5%, with a number needed to treat of eight to prevent one event. The findings also showed significant reductions in 24-hour chest tube drainage and red blood cell transfusions, with no serious device-related adverse events. CytoSorbents expects this analysis to be a core component of a new De Novo submission for DrugSorb-ATR, increasing the treated patient pool roughly five-fold to about 250 patients. Recent FDA pre-submission meetings provided constructive feedback on separate applications for ticagrelor and direct oral anticoagulant removal, with a planned new De Novo submission for the ticagrelor indication in early 2027.

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