CytoSorbents May 6, 2024 Virtual KOL and Analyst-Investor Day: STAR-T Pivotal Trial Topline Results & Real World Experience with Antithrombotic Drug Removal in Europe
PRINCETON, N.J., May 02, 2024 (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 via its proprietary polymer adsorption technology, today announced that it will host a virtual Key Opinion Leader and Analyst-Investor Day on Monday, May 6, 2024 from 11:30 AM to 1:30 PM ET. To register, click here.
The program will cover the significant challenge of severe perioperative bleeding in patients undergoing heart surgery while on blood thinners, including the blockbuster drug Brilinta® (ticagrelor, AstraZeneca). Notably, the experts will review the key findings from the pivotal U.S. and Canadian STAR-T randomized, controlled trial, investigating the safety and efficacy of DrugSorb®-ATR (an investigational FDA Breakthrough Designated Device) to mitigate this issue and the exciting data in the pre-specified CABG population. CABG (coronary artery bypass graft) surgery is the most common cardiac surgery procedure worldwide, driven by high rates of coronary artery disease and heart attacks globally - particularly in the aging baby-boomer population.
In addition, the program will include an overview of real-world use and outcomes with antithrombotic drug removal in cardiac surgery in the European Union, where the application is already approved.
The event will feature Michael J. Mack, MD (Baylor Scott & White Health), C. Michael Gibson, MS, MD (Harvard University), and Richard Whitlock, MD, PhD, FRCSC (McMaster University) - Principal Investigators of the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized controlled trial - and Michael Schmoeckel, MD (Ludwig Maximilians University of Munich).
Live Q&A sessions will follow the formal presentations.
About Michael J. Mack, MD
Michael J. Mack, MD serves as Chair of the Cardiovascular Service Line at Baylor Scott & White Health and Chairman of the Board at Baylor Scott & White Research Institute. He also serves as Vice Chair of the American Board of Thoracic Surgery, Co-Chair of the FDA Heart Valve Collaboratory, and Senior Vice Chair of the NIH Cardiothoracic Surgery Trial Network (CTSN). In addition, Dr. Mack is Associate Editor for both the Journal of the American College of Cardiology (JACC) and the Baylor University Medical Center Proceedings. Dr. Mack has practiced cardiothoracic surgery in Dallas, TX since 1982. He is board certified in Internal Medicine, General Surgery, and Thoracic Surgery and has over 900 peer reviewed publications. Dr. Mack was President of the Society of Thoracic Surgeons (STS) 2011 and is Past President of the Thoracic Surgery Foundation for Research and Education (TSFRE) 2009- 2011, the Southern Thoracic Surgical Association (STSA) 2009 and the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) 2000. He is also a past member of the American College of Cardiology Board of Trustees, Nominating Committee, and Governance Committee and is the past Co-Chair of the STS/ACC National Transcatheter Valve Therapy (TVT) Registry and TVT Stakeholder Advisory Group. He is a Master of the ACC and is an honorary member of the German Society for Thoracic and Cardiovascular Surgery, the Indian Association of Cardiovascular and Thoracic Surgery, Mexican Society of Cardiac Surgery and is the recipient of the Presidential Citation of the American College of Cardiology, the Transcatheter Cardiovascular Therapeutics (TCT) Lifetime Achievement Award and the 2022 American Association for Thoracic Surgery (AATS) Lifetime Achievement Award.
About C. Michael Gibson, MS, MD
C. Michael Gibson, MS, MD is an interventional cardiologist who pioneered our understanding of the open artery and the open microvasculature hypothesis in the setting of heart attack. As an innovator, Gibson invented measures of coronary blood flow that are widely used today (the TIMI frame count (cited 2,636 times), the TIMI myocardial perfusion grade (cited 1,246 times). He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School (formerly known as Harvard Clinical Research Institute) have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Gibson is currently leading the first large “Virtual” randomized trial of 32,000 patients which uses apps and the internet to eliminate “bricks and mortar” and is being conducted at 1% of the usual cost. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. Gibson was ranked the number 1 cardiology influencer on social media in a peer-reviewed article (Kesiena et al). Gibson is an at large member of the FDA’s cardiorenal panel having served as a standing member from 2017 to 2021. He is an accomplished artist whose work is held in numerous collections.
About Richard Whitlock, MD, PhD, FRCSC
Richard Whitlock, MD, PhD, FRCSC is a Professor of Surgery at McMaster University and is the Associate Chair, Research, for the Department of Surgery. He is a practicing cardiac surgeon at Hamilton Health Sciences, and the Chief and Division head for Cardiac Surgery. He is a lead investigator at the Population Health Research Institute and the principal investigator of the LAAOS III trial, which established a new way of stroke prevention in patients with atrial fibrillation. Dr. Whitlock holds the Canada Research Chair in Cardiovascular Surgery. Through the multinational studies that he has led, which include SIRS, TRICS III, VISION Cardiac, and LAAOS III, he has established a network of over 300 collaborating cardiac surgical centers in 32 countries to better the care of patients through robust evidence generation. He is currently leading several industry-partnered trials including LeAAPS, LAAOS IV, and STAR-T.
About Michael Schmoeckel, MD
Michael Schmoeckel, MD has been a practicing academic cardiac surgeon since 1988 with appointments in Cape Town, Papworth, Hamburg and currently at Ludwig Maximilians University of Munich. Professor Schmoeckel’s research interests include xenotransplantation and the use of hemoadsorption in cardiac surgery, including antithrombotic removal where he was one the pioneers in establishing the method in clinical practice and publishing the early clinical experience showing benefits in reducing postoperative bleeding complications. He is an active member of the German Society for Thoracic and Cardiovascular Surgery and has over 120 peer reviewed publications in the top international cardiovascular journals. Prof. Michael Schmoeckel is currently serving as the co-Principal Investigator of the International Safe and Timely Antithrombotic Removal (STAR) registry that is collecting real world evidence with the use of CytoSorb for blood thinner removal at more than 20 heart centers in 5 European countries.
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 2023, more than 228,000 CytoSorb devices had 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 (Brilinta®; AstraZeneca) and rivaroxaban (Xarelto®; Bayer, Janssen) 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 (Eliquis®; Pfizer, Bristol Myers Squibb) and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 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 $50 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™, 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 X (fka 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 results of our STAR-T clinical trial and regulatory submissions relating thereto, 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 14, 2024, 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.
U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com
Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
ir@cytosorbents.com
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