New Publication Reports Significant Reductions in Perioperative Bleeding Complications Following Acute Aortic Dissection Surgery with CytoSorbents’ Antithrombotic Drug Removal Technology

MONMOUTH JUNCTION, NJ, January 24, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in treating life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, highlights a new publication in the peer-reviewed journal, Annals of Thoracic and Cardiovascular Surgery, entitled “Hemoadsorption of rivaroxaban and ticagrelor in type A acute aortic dissection surgery. “In this publication, Hassan et al. reported on the use of intraoperative hemoadsorption using CytoSorbents technology to reduce perioperative bleeding complications in patients with acute type A aortic dissection, a condition life-threatening with a mortality rate of 1-2% per hour, who were either on the direct oral anticoagulant (DOA) rivaroxaban (Xarelto^®Janssen and Bayer) or the platelet aggregation inhibitor ticagrelor (Brilinta^®AstraZeneca) during emergency heart pump surgery.

• The authors performed a retrospective analysis of 171 consecutive patients who underwent urgent surgical repair for acute type A aortic dissection between 2014 and 2020 and identified 21 patients (12.3%) who were either on rivaroxaban (n=9) or under ticagrelor (n = 12).
• Among these 21 patients, 10 patients received intraoperative haemoadsorption, and their operative and clinical results were compared to 11 patients not treated with intraoperative haemoadsorption.
• Baseline characteristics were generally comparable between the two groups, however, hemoadsorption patients were older (mean age 75 versus 62 years) and had a higher perioperative risk based on the calculated EUROSCORE II scale (17.1 versus 10.6; a higher score reflects a higher risk of complications and mortality).
• Although operative techniques and cardiopulmonary bypass time were similar between the two groups, the total operation time was significantly shorter in the hemoadsorption group (286 ± 40 min vs. 348 ± 79 min, p = 0.045) , presumably due to the time required to achieve hemostasis at the end of the operation.
• More importantly, intraoperative hemoadsorption (vs without) was associated with favorable clinical outcomes after urgent type A aortic dissection surgery, including:
• Positive trend in decreasing 30-day mortality: 10% (1/10) versus 27.3% (3/11)
• Zero need for re-operations (vs. 18.2% without hemoadsorption)
• Significantly lower mean chest drainage over 24 hours, an independent predictor of postoperative morbidity and mortality (482 ± 122 ml vs 907 ± 427 ml, p
• Significantly fewer platelet transfusions (p=0.049)
• The above clinical benefits translated into a shorter median ICU length of stay in patients treated with hemoadsorption (4 days) compared to those without (9 days).

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents, said, “This new publication extends the evidence of clinical benefit of intraoperative antithrombotic elimination using our Hemoadsorption Beyond Coronary Artery Bypass Graft (CABG) technology. ) and in other complex cardiac operations, such as type A aortic dissection surgery. All urgent cardiac surgeries are complex and carry a high risk of complications, but as any cardiac surgeon will attest, operating in the presence of antithrombotic drugs such that ticagrelor or DOACs can lead to significant bleeding complications that can negatively impact patient outcomes and increase costs. »

Dr. Deliargyris concluded: “These encouraging data, although from a small single center study, are consistent with published literature on the use of our technology to reduce bleeding complications of cardiothoracic surgery in patients on antithrombotic medications. Additionally, this validates our strategy to include patients undergoing urgent aortic surgery in the STAR-T and STAR-D trials.We plan to incorporate this new data into our recruitment and training efforts with the study sites. The US STAR-T and STAR-D trials, evaluating the use of DrugSorb™‑ATR for the intraoperative removal of antithrombotic drugs during urgent cardiothoracic surgery, are our top priorities. all resources necessary to complete the recruitment of these two studies over the next 12 to 18 months in order to support the po potential future FDA marketing approval.”

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in critical care and cardiac surgery using blood purification. Its flagship product, CytoSorb^®, is approved in the European Union with distribution in over 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in diseases common serious events that can lead to massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, but there are few or no effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. Over 162,000 cumulative CytoSorb devices have been used to date. CytoSorb was originally introduced into the European Union under CE marking as the first cytokine adsorber. Additional CE mark extensions have been received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb also received FDA Emergency Use Authorization in the United States for use in critically ill adult COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic elimination system, which is based on the same polymer technology as CytoSorb, was also awarded Breakthrough FDA designation for the elimination of ticagrelor, as well as Breakthrough FDA designation for withdrawal of the direct oral anticoagulant (DOA) drugs apixaban and rivaroxaban from a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The company has initiated two pivotal FDA-approved trials designed to support the marketing approval of DrugSorb-ATR in the United States. The first is the center for 120 patients, 20 START (Ssafe and Jtimely Aantithrombotic Rmoving house-Jicagrelor) randomized controlled trial evaluating the ability of intraoperative use of DrugSorb-ATR to reduce the risk of perioperative bleeding in patients on ticagrelor undergoing cardiothoracic surgery. The second is the center for 120 patients, 25 STAR‑D (Ssafe and Jtimely Aantithrombotic Rmoving house – Ddirect oral anticoagulants) randomized controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce the risk of perioperative bleeding in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

CytoSorbents 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. Its technologies have received more than $39.5 million in grants, contracts, and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH ), National Heart, Lung, and Blood Institute (NHLBI), U.S. Army, U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others . The company has numerous marketed products and products in development based on this unique blood purification technology protected by numerous issued US and international patents and trademarks, and several pending patent applications, including ECOS-300CY^®CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ^®K⁺ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

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