MONMOUTH JUNCTION, N.J., Oct. 2, 2019 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader using its CytoSorb® blood purification technology to treat life-threatening medical and surgical conditions around the world, announces positive surgical outcomes in a recent publication entitled, “CytoSorb Adsorption During Emergency Cardiac Operations in Patients at High Risk of Bleeding,” in the journal Annals of Thoracic Surgery, ahead of the European Association of Cardio-thoracic Surgery Annual Meeting in Lisbon, Portugal, October 3-5, 2019.
In this recent retrospective study, Dr. Kambiz Hassan, MD, and colleagues at Asklepios Klinik St. Georg in Hamburg, Germany reported on the clinical outcomes of the investigational application of CytoSorb in patients at their institution who underwent emergency cardiac surgery (primarily coronary artery bypass graft surgery) on either ticagrelor or rivaroxaban two commonly prescribed antithrombotic agents. Specific outcomes included the need for blood transfusions, unwanted bleeding events, surgical drainage, and the need for rethoracotomy (i.e. re-opening the chest cavity to explore the source of blood loss). The study evaluated 55 consecutive patients who underwent emergency cardiac surgery between June 2016 and June 2018 while on anti-thrombotic therapy (43 on ticagrelor, 12 on rivaroxaban). Of these, CytoSorb was incorporated into cardiopulmonary bypass in 32 patients on ticagrelor, and 7 on rivaroxaban. Bleeding complications during and after surgery were analyzed in both the CytoSorb adsorption and the Control (no CytoSorb) groups (nominal p-values were computed for clinical outcomes, unadjusted for multiplicity).
- In the CytoSorb adsorption group, none of the 39 patients underwent rethoracotomy, whereas 6 of 16 patients in the Control group required rethoracotomy (0.0% vs 37.5% control, p=0.0003).
- 24-hour median drainage volumes in the CytoSorb group was significantly lower than the Control group (p=0.0037) in patients receiving ticagrelor (350 mL vs 890 mL Control) and rivaroxaban (390 mL vs 600 mL Control).
- Compared with the CytoSorb treated group, the Control group had multiple bleeding complications. In general, transfusion of blood products was not necessary for the majority of CytoSorb treated patients, with 31/39 (79.5%) not requiring packed red blood cell transfusions versus 6/16 (37.5%) Controls, and 26/39 (66.7%) of CytoSorb treated patients not needing platelets, versus 0/16 (0%) controls. Comparison of the incidence rates of transfusion by Fisher’s exact test were significant for both red blood cells (p=0.01198) and for platelet transfusions (p=0.0475).
- Similarly, there were statistically significant increases in complications in Control patients including: longer total operation (p = 0.0042), significantly prolonged stay in the intensive care unit (p=0.0141), and a longer hospital stay (p=0.0244), as compared to CytoSorb treated patients.
Dr. Kambiz Hassan, MD, lead author and Senior Consultant in Cardiac Surgery at Asklepios Klinik St. Georg in Hamburg, Germany stated, “Patients that are on antithrombotic agents such as ticagrelor and rivaroxaban who require urgent or emergent cardiac surgery represent a major surgical management challenge because of the very high perioperative bleeding risk. In this first investigational study on the intraoperative use of CytoSorb adsorption to correct the coagulopathy in these patients, we have demonstrated that its use is safe and effective as a very easy to implement solution to reduce potentially deadly and costly bleeding complications in these patients.”
Dr. Eric Mortensen, MD, PhD, Chief Medical Officer of CytoSorbents, commented, “CytoSorbents is encouraged by this first peer-reviewed publication supporting the investigational use of CytoSorb for the removal of two distinct classes of antithrombotics, the P2Y12 antagonists and the Factor Xa inhibitors, in patients undergoing emergency cardiac surgery. The observed significant reduction in bleeding complications has the potential to save many lives and improve the quality of care, while also helping to avoid costly complications – a compelling combination.”
Dr. Joerg Scheier, MD, Senior Medical Director of CytoSorbents Europe, stated, “These results are a prime example of the excellence of translational medicine in the CytoSorb user community, where ideas that target major unmet medical needs have become reality. We continue to work closely with leading researchers all over the world in dozens of investigator initiated pre-clinical and clinical studies, in many different application areas. CytoSorb is more than a product. It is an innovation engine that is helping to change medicine.”
Ticagrelor (a platelet P2Y12 inhibitor; Brilinta®, Brilique® – Astra Zeneca) is one of the most commonly prescribed antithrombotic medications to reduce the risk of cardiovascular death, myocardial infarction, or stroke in patients with acute coronary syndrome or a history of myocardial infarction. However, studies show that for patients requiring emergency cardiac surgery (e.g. due to aortic dissection, in-stent thrombosis, or acute myocardial infarction) approximately 25-30% will suffer severe or massive peri-operative bleeding with serious morbid complications that significantly increase the risk of death. There is currently no approved reversal agent for P2Y12 inhibitors in emergency cardiothoracic surgery patients, creating a significant unmet need as recognized by the U.S. Food and Drug Administration (FDA). Similarly, the Factor Xa inhibitor, rivaroxaban (Xarelto® – Bayer, Janssen), used to reduce the risk of stroke and systemic embolic events in patients with atrial fibrillation, to reduce major cardiovascular events, in combination with aspirin, in patients with coronary or peripheral artery disease, and to treat or to prevent the recurrence of deep venous thrombosis and pulmonary embolism, also increases the risk of serious or fatal bleeding in emergency cardiac surgery patients. Dr. George Angheloiu, MD and team have previously demonstrated that CytoSorb can rapidly and effectively remove ticagrelor from human blood.
Ticagrelor and rivaroxaban usage is prevalent in major markets worldwide, with collective sales of approximately $7 billion in 2018.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 67,000 human treatments to date.
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 non-dilutive grant, contract, and other funding of nearly $26 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, 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.
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, representations and contentions 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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 7, 2019, 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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CytoSorbents Contact: Amy Vogel Investor Relations (732) 398-5394 |
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