CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

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 regulatory approval from Health Canada allowing inclusion of Canadian sites into the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) randomized, controlled trial.

Richard Whitlock, M.D., Ph.D., FRCSC, Professor of Surgery at McMaster University Medical School and the Population Health Research Institute, Canada Research Chair in Cardiovascular Surgery and Canada Principal Investigator for the STAR-T trial stated, “Canadian cardiac surgery centers are excited to join the STAR-T trial. Ticagrelor is a potent antiplatelet agent with strong evidence of clinical benefit in acute coronary syndromes and is commonly used in the Canadian system. However, managing patients on ticagrelor when they need urgent cardiac surgery is challenging because of the increased bleeding risk. STAR-T will provide definitive evidence whether the DrugSorb-ATR system can effectively remove ticagrelor during surgery and improve clinical outcomes by reducing bleeding. The Population Health Research Institute has successfully completed several of the largest randomized trials in cardiac surgery and will coordinate the STAR-T trial in several of their most successful collaborating sites in Canada. These centers will provide high volume recruitment with high quality data to help answer this important question in a timely manner. Canada is excited to begin recruitment in the pivotal STAR-T trial.”

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “We are very pleased to receive regulatory approval to expand STAR-T into Canada and are now working closely with our partners at the Population Health Research Institute to onboard up to 7 Canadian sites as soon as possible. We anticipate these high performing sites will contribute meaningfully to study enrollment and help us execute on our stated goals of reaching the next milestones of 80 enrolled patients this Spring and full enrollment of 120 patients by Summer 2023.”

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