CytoSorbents Announces Independent Data Safety and Monitoring Board Recommends Completion of the Pivotal STAR-T Trial Without Modifications Following Second Scheduled Safety Review

PRINCETON, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB), following the second scheduled safety review, to complete the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications.

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “We would like to thank the independent DSMB for the prompt review of the full unblinded dataset from the first 80 patients enrolled in the STAR-T trial. We are very pleased with the recommendation to continue the study as planned without modifications that now allows us to push towards the finish line in an expedited fashion. Based on the continued excitement and strong contributions from our U.S. and Canadian investigative sites, we continue to project that the trial, which remains blinded, will complete enrollment this summer.”

The STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study being conducted in both the U.S. and Canada that is designed to evaluate the ability of DrugSorb-ATR to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading “blood thinners” used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug during the surgery. DrugSorb-ATR has received FDA Breakthrough Device Designation for this indication. The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.