CytoSorbents (CTSO) issued an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board analysis for the U.S. and Canadian STAR-T randomized controlled trial. STAR-T is a multi-center trial that investigated the ability of DrugSorb-ATR to reduce perioperative bleeding in 140 enrolled patients on ticagrelor undergoing cardiothoracic surgery before completing the recommended washout period. The company stated that 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 show evidence of reduced bleeding complications in patients in the pre-specified isolated coronary artery bypass graft surgery population, representing more than 90% of the overall study population. Also, the independent DSMB concluded there were no issues with device safety, meeting the primary safety endpoint of the study.
The company expects to complete the analysis of the full trial results in the next several weeks. Pending this, the company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the FDA and Health Canada.
Shares of CytoSorbents are down 29% in pre-market trade on Thursday.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.