By Tom Kerr, CFA
NASDAQ: CTSO
READ THE FULL CTSO RESEARCH REPORT
New Findings Presented at European Society of Cardiology (ESC) Congress 2026
On September 2, 2026, the CytoSorbents (NASDAQ: CTSO) 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.
Patients requiring urgent cardiac surgery after recent exposure to potent blood thinners face substantially higher risks of severe bleeding, transfusions, complications, longer hospital stays, and increased costs, historically necessitating a 3–7 day delay to allow the drugs to clear. CytoSorb offers a potentially significant alternative as the only specifically approved therapy in the E.U. for removing ticagrelor and rivaroxaban during cardiopulmonary bypass. A patient-level matched analysis of 587 urgent CABG patients following recent ticagrelor exposure compared 198 patients treated intraoperatively with CytoSorb in the STAR-T Registry with 389 matched patients from a previously published individual patient data meta-analysis who underwent surgery without the device, with the independent analysis demonstrating meaningful clinical benefits.
- 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 were 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.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."
Phillip Chan, CEO of CytoSorbents, stated, “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. 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."
FDA Pre-Submission Meetings with FDA
CytoSorbents reported continued constructive engagement with the FDA regarding DrugSorb-ATR and its potential use in cardiac surgery patients taking ticagrelor (Brilinta). Recent Pre-Submission discussions helped align the Company and FDA on the mechanistic data and evaluation model needed to support the application. CytoSorbents plans to incorporate the FDA’s feedback and conduct the study, with a new De Novo submission targeted for early 2027 under its Breakthrough Device designation. The submission is expected to include data from the STAR-T randomized trial, patient-level real-world evidence, new mechanistic and usability data, benchtop testing, and previously generated safety data, for which the FDA has identified no major safety concerns.
In parallel, the Company is pursuing a second regulatory pathway for DrugSorb-ATR in cardiac surgery patients taking direct oral anticoagulants (DOACs), including Eliquis and Xarelto. A recent FDA meeting addressed a number of questions and provided further clarity on the potential regulatory path, with a follow-up meeting expected in the near term. Management believes the combination of real-world evidence, consistent STAR-T trial results, and progress with the FDA provides a stronger foundation for future De Novo submissions and could ultimately support U.S. availability of DrugSorb-ATR for patients facing elevated bleeding risks during urgent cardiac surgery.
Valuation and Estimates
We believe these important findings provide some clarity and regulatory visibility for the potential approval of DrugSorb-ATR in 2027. These findings help validate the win-win-win proposition for DrugSorb-ATR where patients, doctors, and hospitals all benefit from this technology. The market appears to recognize the importance of this announcement, as CTSO stock price increased over 13% the day of the announcement.
Based on 2nd quarter 2026 results and management commentary, we adjust our full year 2026 revenue estimate to $38.1 million and adjust our 2026 non-GAAP loss per share to ($0.22). We believe 2027 revenues can reach over $40.0 million without the commercialization of DrugSorb-ATR.
In the 4th quarter of 2025, the company implemented a strategic workforce and cost reduction program which reduced headcount by 10% while also lowering expenses and realigning operating and production spend. According to the company’s recent earnings call, it continues to expect to achieve breakeven in the second half of 2026. We did see the results of these actions in the 2nd quarter as the going forward burn rate was reduced to approximately $200,000 per quarter.
We adjust our price target to $4.00 per share due to the uncertainty of the timing of the DrugSorb-ATR submission and subsequent approval (if approved) in 2027.
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