CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced an independent new patient-level matched analysis of real-world data demonstrating that intraoperative use of CytoSorb was associated with a significant reduction in severe perioperative bleeding among patients undergoing urgent coronary artery bypass grafting (CABG) surgery on the blood thinner, ticagrelor (Brilinta®/Brilique®, AstraZeneca). The findings were presented at the European Society of Cardiology (ESC) Congress 2026, the world’s largest cardiovascular conference, on August 29, 2026.
Real-World Data Summary:
Understanding CytoSorbents in Cardiac Surgery:
The Role of CytoSorbents in Minimizing Bleeding Risks:
Patients on potent blood thinners who require urgent cardiac surgery face a markedly elevated risk of severe bleeding, transfusions, complications, longer hospital stays, and higher costs, creating a significant unmet clinical need. Historically, surgeries were delayed by three to seven days to allow the drug to be naturally eliminated, thereby reducing bleeding risk. Today, CytoSorb represents a much more attractive alternative as the only specifically approved therapy in the E.U. to remove ticagrelor and rivaroxaban during cardiopulmonary bypass.
The patient-level matched analysis included a total of 587 patients undergoing urgent CABG surgery after recent ticagrelor exposure. Patients treated with intraoperative CytoSorb (n=198) from the STAR-T Registry were compared with matched patients from a previously published individual patient data meta-analysis (n=389) who underwent surgery without the device. The independent analysis showed:
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- A significant 37% relative reduction in BARC-4 severe bleeding with CytoSorb use (21.8% vs 34.5% in controls; p=0.002)
- Number of patients needed to be treated (NNT) with CytoSorb to prevent one severe bleeding event after urgent CABG was eight (8)
- Significant reductions in 24-hour chest tube drainage (p=0.039) and red blood cell transfusions (p=0.003) with CytoSorb use was also observed
- No serious device-related adverse events were reported
Prof. Dr. Uwe Zeymer, Vice Director of the Institute for Heart Attack Research in Ludwigshafen, Germany and Co-Principal Investigator of the STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) Registry stated, “Today’s presentation at the ESC meeting using robust statistical adjustments, demonstrates that in real world patients on ticagrelor undergoing urgent CABG, the use of CytoSorb is associated with significant reductions in severe bleeding rates compared with rates observed when patients on ticagrelor are operated without the device.”
Dr. Zeymer continued, “Based on these results, the number of patients needed to be treated with the device to prevent a severe bleeding event after urgent CABG is 8, which is a clinically important result and is highly consistent with the NNT of 6 to prevent a major bleeding event demonstrated in the double-blind randomized STAR-T trial published earlier this year. Therefore, these results validate the testimonials from cardiac surgeons throughout Europe who have made CytoSorb their standard of care when operating urgently on patients on blood thinners. We plan to continue building the evidence base on antithrombotic removal during cardiac surgery beyond ticagrelor to include the direct oral anticoagulants, like apixaban and rivaroxaban, that are also very frequently present in patients requiring urgent cardiac surgery.”
“These real-world findings are highly encouraging and provide important new evidence of CytoSorb’s performance in routine clinical practice in CABG patients facing this critical clinical dilemma,” said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Importantly, we expect this new analysis to serve as a core component of additional clinical evidence – initially proposed by the FDA as part of last year’s appeal – in a new De Novo submission for DrugSorb-ATR to help support its probable benefit in reducing the severity of perioperative bleeding in patients on Brilinta® undergoing urgent cardiac surgery. These data have not yet been submitted or reviewed by the Agency, but are expected to increase approximately five-fold the number of patients treated with our technology in a new De Novo submission, to roughly 250 patients. We believe this substantially expanded body of clinical evidence will further strengthen the case for DrugSorb-ATR and help address the FDA’s prior requests for additional supportive data.”
Ticagrelor Application:
Dr. Chan continued, “Meanwhile, we appreciated the FDA’s continued engagement and constructive feedback in two recent Pre-Submission meetings on DrugSorb-ATR. In the first meeting, we made good progress aligning with the Agency on the type of mechanistic data and the suitability of an evaluation model for the Brilinta® application. We plan to incorporate FDA’s feedback in an iterative process and execute the study, with a planned new De Novo submission in early 2027. This new submission will take place under our FDA Breakthrough Device designation and is expected to include a robust combination of randomized controlled clinical trial data from STAR-T, new patient-level real-world evidence, new mechanistic data, new usability data, benchtop testing, and prior data supporting device safety, where the FDA has previously noted no major safety issues for this application.”
DOAC Application:
“In the second meeting, focused on the use of DrugSorb-ATR in cardiac surgery patients on DOACs such as Eliquis® (apixaban, Bristol Myers Squibb/Pfizer) and Xarelto® (rivaroxaban, Bayer/Janssen), we were encouraged by the interactive dialogue between FDA experts and our own experts and team, where many questions were addressed. Based on this meeting, we intend to continue on this parallel path toward a second De Novo submission and expect a near-term follow-up meeting with the Agency to further define the path forward.”
Dr. Chan concluded, “Taken together, we believe these real-world results, the consistent findings from the STAR-T randomized trial, and constructive progress with the FDA, position CytoSorbents to advance a strengthened regulatory package for DrugSorb-ATR. The Company remains focused on bringing this important therapy to U.S. patients who face serious bleeding risk during urgent cardiac surgery while on potent antithrombotic medications.”
CytoSorb® is approved in the European Union. CytoSorb® and DrugSorb-ATR® are investigational devices in the United States and not yet approved or cleared by the FDA.