New European “Guidelines for the Management of Severe Perioperative Bleeding” Consider Hemoadsorption for the First-Time

PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that hemoadsorption of antithrombotic drugs in cardiothoracic surgery has made its way into the new “2022 Guidelines for the Management of Severe Perioperative Bleeding” by the European Society of Anaesthesiology and Intensive Care (ESAIC) and was published in the European Journal of Anaesthesiology last week.

The aim of this second update to the guidelines previously published in 2017, was to provide an evidence-based set of recommendations to aid in the clinical management of patients at risk of surgical bleeding in a variety of clinical situations. The ESAIC Guideline Committee and Task Force worked with 20 expert affiliate co-authors to conduct a systematic literature search from 2015 – 2021, ultimately identifying approximately 138,000 articles that were assessed and, where appropriate, were used as new evidence to support the new guidelines.

In Section 2.1, “How Should Intra-operative and Postoperative Bleeding be Stopped and Anaemia be Managed” in patients undergoing cardiovascular surgery, the committee reviewed published studies using CytoSorb^® to reduce bleeding complications in patients undergoing cardiac surgery on antithrombotic agents and made the following recommendation:

“In patients on ticagrelor or rivaroxaban undergoing emergency cardiac/aortic surgery on CPB [cardiopulmonary bypass], haemoadsorption may be considered as an adjuvant therapy to reduce bleeding complications.”

Dr. Christian Steiner, Executive VP Sales & Marketing of CytoSorbents, stated, “This is another step forward in helping to establish our blood purification technologies as the preferred way to prevent severe bleeding in patients on blood thinning medications undergoing cardiac surgery today, and potentially other surgeries in the future. CytoSorb^® is already CE mark approved in the European Union to remove the blood thinners Brilinta^®/Brilique^® (ticagrelor, AstraZeneca) and Xarelto^® (rivaroxaban, Bayer, Janssen/Johnson & Johnson) during cardiothoracic surgery, and is being used for these indications in many hospitals throughout the world. We are excited that hemoadsorption of blood thinning medications has been considered in these updated European guidelines for the first time and that the concept is being highlighted to a broad and relevant audience.”

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The recognition of hemoadsorption of blood thinning drugs in these guidelines is a nice validation of our DrugSorb-ATR^® clinical program in the U.S. and Canada. Should the ongoing STAR-T pivotal randomized controlled trial demonstrate that the DrugSorb-ATR system, which uses an equivalent polymer technology as CytoSorb, can safely reduce bleeding complications in cardiothoracic surgery patients on Brilinta^®, we expect the data to not only support U.S. FDA and Health Canada marketing approval, but to also help establish our technologies as the standard of care therapy for this major unmet medical need in treatment guidelines worldwide.”

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb^®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. 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. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also 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. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.

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 approximately $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the 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 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™, 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. 

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, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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 10, 2022, 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:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com