Cytosorbents reports breakthrough real-world data on reducing bleeding in CABG patients on ticagrelor using CytoSorb therapy at EuroPCR 2025

In a significant update presented at EuroPCR 2025 in Paris, CytoSorbents Corporation (NASDAQ: CTSO) revealed compelling real-world data showing that its flagship blood purification device, CytoSorb®, led to substantial reductions in severe bleeding complications during urgent coronary artery bypass grafting (CABG) in patients on the potent antithrombotic agent ticagrelor (marketed as Brilinta® by AstraZeneca). This announcement, made during a session attended by global interventional cardiology leaders, strengthens CytoSorbents’ position as a leader in extracorporeal blood purification for life-threatening surgical and intensive care scenarios.

The newly presented analysis was based on outcomes from the STAR (Safe and Timely Antithrombotic Removal) Registry and compared against a recently published meta-analysis of non-device-treated patients. The data confirmed that intraoperative CytoSorb® use can meaningfully reduce bleeding severity, transfusion needs, and reoperation rates in CABG patients who could not complete the recommended three-day ticagrelor washout.

What Did the STAR Registry Reveal About CABG Patients on Ticagrelor?

Professor Robert F. Storey, co-Principal Investigator of the STAR Registry and Academic Director at Sheffield Teaching Hospitals in the UK, presented findings from a comparative real-world study that included 150 patients operated on with CytoSorb® versus 644 patients from a prior peer-reviewed meta-analysis who underwent surgery without it. All patients had received ticagrelor but did not complete the standard 72-hour washout before surgery, elevating their bleeding risk.

The STAR Registry patients, drawn from 28 cardiac surgery sites across six European nations, were shown to have significantly lower rates of severe bleeding events based on the Bleeding Academic Research Consortium (BARC-4) criteria. Only 10.7% of CytoSorb-treated patients experienced severe bleeding, versus 33% in the non-device group. Similarly, large-volume blood transfusion events (≥5 units) were significantly lower at 6% versus 27%. Reoperations due to bleeding were reduced by more than half (4% vs. 9.6%).

Despite these clinical advantages, 30-day mortality rates remained statistically comparable between the two groups. Notably, no device-related adverse events or functional deficiencies were reported, underscoring the safety and operational ease of CytoSorb® in urgent cardiothoracic procedures.

How Does CytoSorb® Function in High-Risk Surgeries?

CytoSorbents’ proprietary blood purification technology uses biocompatible polymer beads with high surface area and porosity to adsorb and remove harmful substances from blood. These substances include inflammatory mediators, toxins, and in the context of this study, antithrombotic agents like ticagrelor.

During surgery, CytoSorb® can be seamlessly integrated into cardiopulmonary bypass (CPB) circuits. This allows real-time purification of the patient’s blood, reducing the presence of free ticagrelor that can otherwise significantly increase intraoperative bleeding risk. By reducing residual drug levels, CytoSorb® minimizes complications without compromising the antiplatelet therapy’s earlier benefits.

Why Is This Data Crucial for Hospitals and Cardiac Surgeons?

CABG procedures are frequently performed on patients with acute coronary syndrome who are often on dual antiplatelet therapy, including ticagrelor. Guidelines recommend a waiting period of at least three days post-ticagrelor cessation before surgery to allow for drug clearance and reduce bleeding risk. However, many patients cannot afford this delay due to their critical cardiac condition.

CytoSorb® provides a clinically validated alternative for hospitals and surgeons who must urgently operate on these patients. The reduction in blood transfusions and reoperations not only improves patient safety but also reduces procedure-related costs and resource burdens on healthcare systems.

Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents, emphasized that these real-world results mark a turning point. He noted that patients at heart centers routinely using the device now show better outcomes compared to those treated under standard protocols without the technology. Dr. Phillip Chan, CEO of CytoSorbents, echoed these sentiments and highlighted the strategic importance of expanding the device’s adoption globally.

What Is the Regulatory Status of CytoSorb and DrugSorb-ATR?

While CytoSorb® is CE-marked and marketed in over 70 countries, including throughout the European Union, it has not yet received full regulatory clearance in the United States or Canada. CytoSorbents is actively pursuing FDA approval for DrugSorb™-ATR, its U.S.-marketed equivalent developed to remove blood thinners during surgery.

The company received two FDA Breakthrough Device Designations: one for ticagrelor removal and another for direct oral anticoagulants (DOACs) like apixaban and rivaroxaban. In September 2024, CytoSorbents submitted a De Novo request for DrugSorb-ATR targeting ticagrelor removal in CABG patients. However, the FDA denied this application in April 2025, citing remaining deficiencies. The company plans to appeal this decision and is optimistic about a resolution within 2025, facilitated by direct engagement with FDA leadership and external surgical experts.

In parallel, CytoSorbents is pursuing approval from Health Canada, where the DrugSorb-ATR application remains under advanced review. Despite delays due to a broader regulatory backlog, Health Canada reaffirmed its intent to finalize the decision as soon as feasible.

How Does CytoSorbents Position Its Portfolio Beyond CABG?

CytoSorbents’ technology extends beyond cardiac surgery. It is used in intensive care units to treat life-threatening conditions such as sepsis, acute liver failure, cytokine release syndrome, and trauma-related complications. The underlying polymer-based adsorption platform is adaptable across extracorporeal therapies like dialysis, ECMO, and CRRT.

The company’s product pipeline includes additional applications such as the HemoDefend™ platform for blood transfusion safety and veterinary-focused VetResQ®. Ongoing innovation is supported by a robust intellectual property portfolio comprising numerous patents across North America and Europe.

What Do These Results Mean for CytoSorbents’ Commercial Strategy?

The EuroPCR 2025 results are likely to drive broader clinical adoption in Europe, where the device is already widely available. Positive real-world outcomes such as those from the STAR Registry provide essential validation for hospitals evaluating cost-effective solutions for high-risk surgeries.

Institutional sentiment toward CytoSorbents appears cautious but increasingly constructive. While the denial of the De Novo request from the FDA was a setback, the company’s active appeal process and extensive global use offer confidence in eventual regulatory traction. Investors will closely monitor the company’s regulatory milestones in the U.S. and Canada over the next two quarters, as these will shape commercial potential in two of the world’s largest medical device markets.

With over 250,000 units used to date, CytoSorbents is approaching critical mass in terms of real-world data and clinical validation. The strong outcomes presented at EuroPCR 2025 are likely to influence both hospital procurement decisions and broader regulatory perceptions of intraoperative blood purification as a viable adjunct in cardiac care.

How Might This Shape the Future of Antithrombotic Surgery Management?

As the number of patients on potent antithrombotic agents continues to grow, the clinical need for technologies that enable safe and timely surgical intervention is expanding. CytoSorb® and DrugSorb™-ATR could become indispensable tools for cardiac surgeons, intensivists, and hospital systems striving to balance bleeding risks against surgical urgency.

Given the limitations of pharmacologic reversal agents for drugs like ticagrelor, CytoSorbents’ extracorporeal approach offers a scalable, device-based solution that fits seamlessly into current operating room protocols. Provided future regulatory approvals are secured in North America, CytoSorbents is well-positioned to capture a sizable share of the surgical blood purification market.