- Patient-level matched analysis of real-world data demonstrated a significant 37% relative reduction in severe bleeding
- Significant reductions in 24-hour chest tube drainage and red blood cell transfusions were also seen, with no serious device-related adverse events reported
- Findings reinforce results from the STAR-T trial and are expected to form a core component of additional real-world evidence planned for a new U.S. FDA De Novo submission for DrugSorb-ATR®
- Recent FDA Pre-Submission meetings provided constructive feedback on potential U.S. regulatory pathways for DrugSorb-ATR for separate applications for ticagrelor and direct oral anticoagulant removal in urgent cardiac surgery
PRINCETON, N.J., Sept. 2, 2026 /PRNewswire/ — 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:
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:
- 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.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States.
In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is actively pursuing regulatory approval of DrugSorb-ATR with the U.S. FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA. DrugSorb-ATR is not yet granted or approved in either the U.S. or Canada.
The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, PuriFi®, HotSwap®, and others. For more information, please visit the Company’s website at https://ir.cytosorbents.com/ or follow us on Facebook and X.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to reduce costs, optimize operations, and achieve cash-flow break-even in the second half of 2026, our ability to appropriately finance the Company, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 30, 2026, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
[email protected]
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