CytoSorbents Corporation announced an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board ("DSMB") analysis for the pivotal U.S. and Canadian STAR-T ("Star-T") randomized controlled trial. STAR-T is a double-blind, randomized, controlled, multi-center pivotal trial that investigated the ability of DrugSorb -ATR to reduce perioperative bleeding in 140 enrolled patients on ticagrelor (Brilinta, Brilique - AstraZeneca) undergoing cardiothoracic surgery before completing the recommended washout period. The Company has also performed the initial data analysis on the primary effectiveness endpoint of STAR-T. Based on this analysis, the study did not meet the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries.

However, the study did demonstrate evidence of reduced bleeding complications in patients in the pre-specified isolated coronary artery bypass graft ("CABG") surgery population, representing more than 90% of the overall study population. The Company expects to complete the analysis of the full trial results in the next several weeks. Pending this final analysis, the Company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the U.S. FDA and Health Canada.

Meanwhile, the Company had previously submitted a promissory abstract to the American College of Cardiology 2024 conference, triggering a "silent" period for publicly discussing detailed study results. If accepted, the full results of the STAR-T trial are expected to be presented next April 2024 in Atlanta. Ticagrelor is one of the leading anti-thrombotic drugs used as part of dual-antiplatelet therapy in patients with acute coronary syndrome.

DrugSorb-ATR has been previously granted U.S. FDA Breakthrough Device Designation, acknowledging that perioperative bleeding in cardiac surgery due to ticagrelor is a major unmet medical need. With Breakthrough Designation, CytoSorbents intends to work with FDA to facilitate the regulatory review of drugSorb-ATR, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k), or premarket approval (PMA)) consistent with the Agency's mission to protect and promote public health. 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 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 DrugS. and Canada can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardioth oracic surgery.

This pivotal study is intended to support U.S. FDA and health Canada marketing approval for DrugS. FDA and Health Canada marketing approval for DrugSorb-ATR.