Cytosorbents (CTSO) Receives Full FDA Approval of IDE for U.S. STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery

CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized, controlled trial (RCT) in the United States to support FDA regulatory clearance. This study is being performed under the previously announced FDA Breakthrough Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with CytoSorbents' proprietary polymer adsorption technology.

Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "We are pleased to announce the FDA has granted full IDE approval for the randomized, controlled, double-blind STAR-T trial designed to support regulatory clearance of the newly designated DrugSorb-ATR™ Antithrombotic Removal system for intraoperative ticagrelor removal during cardiothoracic surgery. STAR-T will enroll up to 120 patients across 20 U.S. clinical sites and is expected to begin enrollment this summer. The primary endpoint of the study will evaluate whether the use of DrugSorb-ATR with standard of care in patients on ticagrelor undergoing cardiothoracic surgery reduces the risk of peri-operative bleeding complications compared to standard of care alone. The trial will also evaluate reductions in ticagrelor blood levels and a number of additional outcomes to capture the full potential clinical and cost-economic benefits of DrugSorb-ATR. We believe the study can be completed in 2022 based on the high level of excitement and engagement we are seeing from participating sites. Finally, we will continue to collaborate closely with the FDA to leverage the priority review associated with our ticagrelor removal application in the spirit of the granted Breakthrough Designation."

Michael Mack, MD, Chair of Cardiovascular Service Line at Baylor Scott & White Health, President of Baylor Scott & White Research Institute, and Principal Co-Investigator of the STAR-T study stated, "Performing cardiac surgery in patients while on antithrombotic agents such as ticagrelor is a major issue at every U.S. cardiac surgery center due to the very high risk of perioperative bleeding. Such bleeding is a major cause of morbidity, mortality and added costs, and is a vexing patient management problem for cardiac surgeons worldwide. Currently we have to either delay surgery until the effects of the antithrombotic agent wear off, or if the patient cannot wait due to the urgency of their condition, proceed with the elevated bleeding risk. The STAR-T study will evaluate whether intraoperative removal of ticagrelor with DrugSorb-ATR can safely reduce bleeding complications. We designed the STAR-T trial with the rigor of a randomized controlled trial to generate the highest level of evidence to determine outcomes that will hopefully benefit every heart center worldwide."

C. Michael Gibson, MD, Professor of Medicine, Harvard Medical School and President and Chief Executive Officer of the non-profit Baim Institute (formerly Harvard Clinical Research Institute) and also Principal Co-Investigator of STAR-T, stated, "The continuing worldwide growth in the use of antithrombotic medications and the numbers of patients who require surgery and are at risk of bleeding while on them, continues to rise. DrugSorb-ATR is a novel, easy-to-implement potential solution to this major clinical problem. Evidence from real-world use of this technology in Europe to remove antithrombotic drugs during cardiac surgery suggests significant benefits to patients due to reductions in perioperative bleeding with substantial cost savings to hospitals. Should these same results be confirmed in the STAR-T randomized controlled trial, then DrugSorb-ATR could become the new global standard of care for these challenging patients."

In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need. Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent heart attack, stroke, or cardiovascular death. Ticagrelor is frequently preferred as first-line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement. However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery. As several clinical studies, such as the PLATO trial, have shown, they face a very high risk of severe or life-threatening perioperative bleeding. CytoSorbents' CytoSorb® therapy is the only treatment approved to remove ticagrelor during cardiopulmonary bypass in the E.U. The DrugSorb-ATR™ Antithrombotic Removal system is based on the same polymer technology as CytoSorb®. If cleared by the FDA, DrugSorb-ATR™ would be marketed in the United States for ticagrelor removal in a cardiopulmonary bypass circuit during cardiothoracic surgery. The product name reflects the intended premium indication of ticagrelor removal in the U.S. and is consistent with our future goal of expanding the U.S. label to remove other antithrombotic agents.

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