CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation - Seite 2

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents, stated, “We are encouraged that the use of the DrugSorb-ATR device in this high-risk population was deemed safe by the independent DSMB. Although the primary effectiveness endpoint of the study was not met in the overall population, we identified evidence of benefit of reduced bleeding complications in patients undergoing isolated CABG surgery, including serious bleeding events. This suggests a favorable benefit-to-risk profile in this population that represents the vast majority of ticagrelor-treated patients requiring cardiac surgery. Additional analyses are ongoing and we look forward to sharing the detailed results at a major medical conference in the near future.”

Dr. Irina Kulinets, Senior Vice President of Global Regulatory of CytoSorbents, stated, “In the next several weeks, we aim to complete the full data analysis of the study that is intended to form the basis of anticipated regulatory submissions. From a regulatory perspective, it is important that DrugSorb-ATR successfully met the primary safety endpoint of the study and has demonstrated clinical evidence of effectiveness in the pre-specified isolated CABG subpopulation. These data are supported by the successful real-world usage of CytoSorb for this same indication, as captured by our International STAR Registry and as seen in multiple world markets including Europe, Latin America, Middle East, and others. Although we cannot predict how FDA will view our results, we are encouraged that FDA has already granted Breakthrough Device Designation to DrugSorb-ATR for this application, recognizing the problem as a major unmet medical need that causes significant patient morbidity and mortality and has no approved therapy in the U.S.”

Ticagrelor is one of the leading anti-thrombotic drugs used as part of dual-antiplatelet therapy in patients with acute coronary syndrome. However, up to 10% of these patients will need to undergo CABG surgery and risk serious bleeding complications if the surgery is performed within the first few days from the last ticagrelor dose. Waiting in the hospital to washout the drug over the span of 3-5 days is the only acceptable alternative, but comes with potential clinical risk for complications while waiting, and high additional hospital costs. The goal of DrugSorb-ATR is to allow patients to safely get the critical CABG surgery they need without requiring extensive drug washout.