CytoSorbents Therapy Significantly Reduces Bleeding in Urgent CABG Patients on Ticagrelor in New Data Presented at EuroPCR 2025

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) presented new real-world data at EuroPCR 2025 demonstrating significant benefits of their blood purification technology. The study compared 150 patients from the STAR Registry using CytoSorbents' device to 644 control patients during urgent CABG surgery while on ticagrelor. Key findings showed remarkable reductions in bleeding complications: BARC-4 severe bleeding (10.7% vs 33%, p<0.001), large transfusion events (6% vs 27%, p<0.001), and re-operations for bleeding (4% vs 9.6%, p=0.02). The device showed no adverse events, proving both safe and effective in removing ticagrelor from blood during cardiac surgery. The study included patients from 28 sites across 6 European countries, with comparable baseline characteristics between groups including age, acute coronary syndrome presentation, and perioperative risk.

Positive

• Significant reduction in BARC-4 severe bleeding (10.7% vs 33%, p<0.001)
• Major decrease in large transfusion events (6% vs 27%, p<0.001)
• Lower rate of re-operations for bleeding (4% vs 9.6%, p=0.02)
• No device-related adverse events or deficiencies reported
• Growing adoption by cardiac surgery centers worldwide

Negative

• None.

Insights

Medical Device Specialist

CytoSorbents' blood purification device significantly reduces severe bleeding complications in urgent cardiac surgery patients on ticagrelor, addressing a critical clinical need.

The data presented at EuroPCR 2025 represents a significant clinical advancement for CytoSorbents' blood purification technology. The comparative analysis examined 150 patients from the STAR Registry using CytoSorbents' device versus 644 control patients who underwent urgent CABG surgery while still on ticagrelor without completing the recommended 3-day washout period.

The results demonstrate compelling clinical benefits with statistically significant reductions in severe bleeding complications:

• BARC-4 severe bleeding reduced by 67.6% (10.7% vs. 33% control, p<0.001)
• Large transfusion events (≥5 units) reduced by 77.8% (6% vs. 27% control, p<0.001)
• Re-operations for bleeding reduced by 58.3% (4% vs. 9.6% control, p=0.02)

These outcomes address a major unmet clinical need. Patients requiring urgent cardiac surgery while on potent antiplatelet agents like ticagrelor typically face significantly increased bleeding risks, often necessitating delays in potentially life-saving procedures. The device appears to effectively remove ticagrelor from the circulation during cardiopulmonary bypass, enabling safer urgent surgery without the guideline-recommended waiting period.

Importantly, the study reported no device-related adverse events, confirming real-world safety and ease-of-integration into standard cardiopulmonary bypass circuits. The similar baseline characteristics between groups, including identical distribution of time since last ticagrelor dose, strengthen the validity of these findings.

The ongoing STAR Registry spanning 28 sites across 6 European countries provides robust real-world evidence supporting CytoSorbents' technology as a potential standard of care for this specific high-risk patient population undergoing cardiac surgery.

Healthcare Financial Analyst

CytoSorbents' strong clinical data showing significant bleeding reduction in cardiac surgery strengthens market position and revenue potential.

This EuroPCR 2025 presentation provides compelling evidence for the clinical efficacy of CytoSorbents' blood purification technology in a well-defined, high-risk patient population. The presented data represents a significant value proposition for the company's commercialization efforts in the cardiac surgery market.

The strong statistical significance across all bleeding endpoints demonstrates clear clinical utility that addresses a specific unmet need: managing patients on ticagrelor requiring urgent CABG surgery. This represents a sizeable market opportunity, as ticagrelor (Brilinta®) remains a widely prescribed P2Y12 inhibitor for acute coronary syndrome patients.

From a market adoption perspective, the data provides compelling evidence for hospitals to incorporate this technology into standard protocols. The reduction in severe bleeding complications (10.7% vs. 33%) and large transfusion events (6% vs. 27%) translates to potential cost savings through:

• Reduced blood product utilization
• Fewer reoperations for bleeding (4% vs. 9.6%)
• Potentially shorter ICU and hospital stays

The multi-center, multi-country STAR Registry (28 sites across 6 European countries) shows growing clinical adoption, creating a foundation for expanded reimbursement and regulatory approvals. This real-world evidence approach complements traditional clinical trials and could accelerate market penetration.

For CytoSorbents, this data strengthens their competitive position in the cardiac surgery space while potentially expanding addressable market opportunities. With growing clinical evidence demonstrating clear patient benefits and the absence of reported device-related adverse events, the company is positioned to drive adoption across cardiac surgery centers worldwide, potentially translating to accelerated revenue growth.

Real-World Analysis Shows Statistically Significant Reduction in Severe Bleeding and Transfusion Needs in CABG Patients on the Blood Thinner, Ticagrelor, with CytoSorbents Therapy

PRINCETON, N.J., May 22, 2025 /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, announced today's presentation at EuroPCR 2025 of a new contemporary real-world data analysis highlighting the intraoperative use of its technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta^®, AstraZeneca) who had not completed the recommended drug washout period. 

Presented by Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust (U.K.) and co-Principal Investigator of the international STAR (Safe and Timely Antithrombotic Removal) Registry, the findings were shared during the session titled, "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data."

Key Study Insights

The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the guideline-recommended 3-day washout period. The device group consisted of an updated cohort of 150 patients from the STAR Registry who were all operated on with the use of CytoSorbents' device, while the control group comprised 644 similar patients from a recent publication who were all operated on without the use of the device.

The results showed statistically significant and clinically meaningful reductions in severe bleeding complications with device use, including:

• Reductions in the rate of BARC-4 (validated measure of severe bleeding after CABG) severe bleeding: 10.7% vs. 33% control, p<0.001)
• Reduction in large transfusion events (≥5 units of blood): 6% vs. 27% control, p<0.001)
• Reduction in the need for re-operations to control bleeding (4% vs. 9.6% control, p=0.02)

Importantly, no device-related adverse events or device deficiencies were reported by participating centers, underscoring the device's ease-of-use and safety in real-world clinical practice. 

Professor Storey concluded his presentation, stating, "A device that removes free ticagrelor from blood and is easily integrated into the CPB circuit appears safe and effective in mitigating excess bleeding in ticagrelor-treated patients undergoing CABG surgery before completing the 3-day washout,"

Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "Today's presentation in Paris is a vital addition to the growing evidence base of blood thinner removal with our technology. The data show that device use is simple and safe but more importantly establish that patients on ticagrelor undergoing urgent CABG at heart centers using our device as part of their standard care, experience significantly lower bleeding complications compared to patients operated without the device. We are thrilled with these new data that support routine use of our device as an effective solution to address the major unmet medical need of patients on blood thinners like ticagrelor requiring urgent cardiac surgery."

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, noted, "We are proud to see the updated STAR Registry data presented alongside one of the largest and most recent meta-analyses of non-device treated CABG patients on Brilinta^®.  With growing adoption of our technology by cardiac surgery centers worldwide, this important real-world evidence from our registry reinforces the clinical value of our therapy that we hope to bring to all countries and patients around the world."

Additional Presentation and Study Details

In today's oral presentation titled "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data" at the 2025 EuroPCR conference in Paris, France, the world-leading course in interventional cardiovascular medicine with over 12,000 attendees, Professor Robert Storey presented the results of a comparative analysis in patients on ticagrelor undergoing CABG surgery before completing the recommended three-day washout period with or without the intraoperative use of the CytoSorb^® device.

• Device group: 150 patients from the STAR Registry that is actively enrolling at 28 sites in 6 European countries (Germany, United Kingdom, Austria, Belgium, Sweden and Switzerland) who were all operated with the use of the device
• Control group: 644 similar patients from the recently published individual patient data meta-analysis in the peer-reviewed journal, European Journal of Cardiothoracic Surgery, who were all operated without the use of the device

Key Data Highlights:

• There were no significant differences in baseline characteristics between the two groups (device vs. control), including age (65 vs. 67 years), acute coronary syndrome presentation (90.5% vs. 89.1%) and overall perioperative risk according to Euroscore II (2.5 vs. 2.8%). Most importantly, the two groups had near identical distribution of the time of CABG relative to the last dose of ticagrelor, a very strong factor determining bleeding risk (within 1 day of last dose 41.4% vs. 41.9%, more than 1 but less than 3 days 58.6% vs. 58.1%).
• The primary outcome of the analysis was incidence of the composite of severe bleeding according to the Bleeding Academic Research Consortium (BARC)-4 definition that includes: intracranial bleeding; re-operation for bleeding; transfusion ≥ 5 units of packed red blood cells (pRBC) and 24-hour chest tube drainage of ≥ 2 liters. Additional individual outcomes included the rate of large transfusion events (≥ 5 units of pRBC) and the rate of re-operation for bleeding.
• BARC-4 bleeding was significantly reduced with the use of the device (10.7% vs. 33% control, p<0.001) as were large transfusion events (6% vs. 27% control, p<0.001) and re-operations for bleeding (4% vs. 9.6% control, p=0.02). Mortality at 30 days was not different between the 2 groups (4.4% vs. 6.5%, p=ns). Importantly, there were no device deficiencies or device-related adverse events reported by participating centers, underscoring the ease and safety of the use of the device in the real world.

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 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 a quarter million 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 procedures.  In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S.  The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts.  Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025.   In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review.  While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity.  The Company remains confident in receiving a final regulatory decision in 2025.  DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. 

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, 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, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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
pmariani@cytosorbents.com 

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare  ir@cytosorbents.com 

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SOURCE Cytosorbents Corp

FAQ

What were the key results of CTSO's blood purification device in CABG patients?

The device significantly reduced BARC-4 severe bleeding (10.7% vs 33%), large transfusion events (6% vs 27%), and re-operations for bleeding (4% vs 9.6%) in CABG patients on ticagrelor.

How many patients were included in CytoSorbents' STAR Registry study?

The study compared 150 patients using CytoSorbents' device from the STAR Registry against 644 control patients who underwent CABG surgery without the device.

What is the purpose of CytoSorbents' device for CABG patients?

The device removes ticagrelor (blood thinner) from blood during urgent CABG surgery, helping reduce bleeding complications in patients who haven't completed the recommended 3-day washout period.

Were there any safety concerns with CytoSorbents' device in the study?

No device-related adverse events or device deficiencies were reported, demonstrating the device's safety and ease of use in real-world clinical practice.

Which countries participated in CytoSorbents' STAR Registry?

The STAR Registry included 28 sites across 6 European countries: Germany, United Kingdom, Austria, Belgium, Sweden, and Switzerland.