Cytosorbents announces Health Canada regulatory approval for the pivotal STAR-T test

Princeton, NJ, January 23, 2023 /PRNewswire/ — Cyto Sorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery, using blood purification through its proprietary polymer adsorbent technology, announced that it has been granted permission to include Canadian sites Granting has received regulatory approval from Health Canada. decisive sFE and TeaSoon anithrombotic RImmovable – TeaIkgrelar (Start) randomized controlled trial.

Richard WhitlockMD, PhD, FRCSc, Professor of Surgery McMaster University Medical School and Population Health Research Institute, Canada Research Chair in Cardiovascular Surgery and Canada Principal Investigator for the STAR-T trial said, “Canadian cardiac surgery centers are excited to join the STAR-T trial. Ticagrelor with a strong Potent antiplatelet agent. Evidence of clinical benefit in acute coronary syndrome and commonly used in the Canadian system. However, patients on ticagrelor when they require urgent cardiac surgery due to increased risk of bleeding STAR-T will provide definitive evidence whether the DrugSorb-ATR system can effectively remove ticagrelor during surgery and improve clinical outcomes by reducing bleeding. Population Health Research Institute has successfully completed several of the largest randomized trials in cardiac surgery and will coordinate the STAR-T trial at its most successful partner sites in Canada. These centers will provide high-volume recruitment with high Quality data to help answer this important question in a timely manner. Canada We are excited to begin recruiting into the pivotal STAR-T trial.”

Chief Medical Officer, Cytosorbents Dr. Efthimios N. Deliergyaris said, “We are very pleased to have received regulatory approval for the expansion of Star-T. Canada And are now working closely with our partners at the Population Health Research Institute to get the 7 Canadian sites onboard as quickly as possible. We anticipate that these high-performing sites will contribute meaningfully to study enrollment and meet our stated goals of reaching the next milestone of 80 enrolled patients this spring and full enrollment of 120 patients by the summer of 2023. will help you complete it.

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. Its flagship product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that alleviates the “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 very high, and there are few, if any, 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. In form of September 30, 2022, over 186,000 CytoSorb devices have been used cumulatively. Cytosorb was originally launched in the European Union as the first cytokine adsorber under the CE mark. Additional CE mark extensions were granted for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and for the removal of ticagrelor and rivaroxaban in cardiothoracic surgery procedures. CytoSorb has also received FDA emergency use authorization. United States For use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and the other for the direct oral anticoagulants (DOACs) apixaban and rivaroxaban. Cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company is currently conducting an FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in the US and the US. Canada To evaluate whether the intraoperative use of Drugsorb-ATR can reduce the peripheral risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This important study aims to support FDA and Health Canada marketing approval United States And Canadarespectively, for DrugSorb-ATR in this application.

The purification technologies of cytosorbents are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore and surface adsorption. Its technologies have received almost non-mixing grants, contracts and other funding. $48 million from DARPA, US Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI), US Army, US Air Force, US Special Operations Command (SOCOM), Air Force Command (USAF/AFMC), and others. The company has several marketed products and products under development based on this unique blood purification technology protected by multiple issued US and international patents and registered trademarks, and several 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 contains forward-looking statements for the purpose of qualifying 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 regarding our plans, objectives, goals for the future. and expectations regarding the outlook for our business, the future effects of COVID-19 or the ongoing conflict between Russia And this ukraine, represent and dispute and are not historical facts and are usually accompanied by words such as “may,” “should,” “might,” “expect,” “plan,” “estimate,” “believe,” “estimate,” recognized by use. The words “forecast,” “potential,” “continue,” and similar words, however, refer to certain forward-looking statements expressed differently. You should be aware that forward-looking statements in this press release are based on management’s current decisions. and represent expectations, but our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences are included in our Form 10-K filed with the SEC. The risks discussed in our annual report include, but are not limited to. 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 issued by us from time to time, in an effort to advise shareholders of the risks and factors is done that may affect our business. , We caution you not to place undue reliance on any such forward-looking statement. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required under the federal securities laws.

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Cyto Sorbents Contact:
Kathleen Bloch
(732) 398-5429
[email protected]

SOURCE Cytosorbents Corporation

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