CytoSorbents: DrugSorb-ATR Study Fails To Meet Primary Effectiveness Endpoint

(RTTNews) - 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.

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