CytoSorbents Completes Enrollment of the STAR-T Pivotal Trial

PRINCETON, N.J., July 07, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed enrollment of the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) randomized, controlled trial, evaluating the ability of DrugSorb-ATR to reduce perioperative bleeding in patients undergoing cardiothoracic surgery on ticagrelor.

The STAR-T trial Principal Investigators, Drs. Michael Mack, C. Michael Gibson, and Richard Whitlock, commented in a joint statement, “We want to thank all participating investigators and their research teams for their commitment and dedication that helped STAR-T complete enrollment ahead of projections. Ticagrelor (Brilinta, AstraZeneca) is used widely in the U.S. and Canada and we routinely encounter patients on ticagrelor who require cardiothoracic surgery. Currently, because of the high risk of bleeding complications in these patients, we delay surgery for multiple days until the ticagrelor effect is worn off which carries the risk that these patients suffer a complication while waiting, but also significantly increases the length and cost of their hospitalization. The surgical community is in urgent need of a solution that allows the safe and timely treatment of these high-risk patients. We look forward to the results of STAR-T which we plan to present at a major international cardiovascular conference in early 2024 and remain committed to lead further trials investigating drug removal by DrugSorb-ATR of additional antithrombotic agents, such as the direct oral anticoagulants apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto, Janssen/Bayer) that are among the most widely prescribed medications in the world.”

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are very pleased to deliver STAR-T across the finish line ahead of schedule. The fast enrollment pace was the direct result of the high frequency that eligible patients presented at our participating sites validating the large size of the unmet need. With this major milestone achieved, our attention now turns to completion of data collection and study closeout activities ahead of the final results. With our clinical operations capabilities now fully in place we look forward to executing the next round of trials, including STAR-D, investigating the expansion of antithrombotic drug removal to additional agents and hospital wide applications beyond cardiac surgery.”