PRINCETON, N.J., June 24, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSo ...

Core Insights - CytoSorbents Corporation has appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR in the U.S. and Canada, anticipating marketing approval [1][2] - DrugSorb-ATR is positioned to address perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta® [2][3] - The company expects regulatory decisions from the U.S. FDA and Health Canada regarding DrugSorb-ATR in 2025, with the device currently classified as investigational [3][8] Company Overview - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [5][6] - The company's proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including cardiothoracic surgery [5][6] - CytoSorbents' lead product, CytoSorb®, is already approved in the European Union and has been used in over 70 countries, with more than 250,000 devices utilized to date [7] Product Development - DrugSorb-ATR is an investigational device designed to reduce perioperative bleeding severity in high-risk surgeries due to blood thinners, having received two FDA Breakthrough Device Designations [8] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR in September 2024, which is currently under substantive review [8] - CytoSorbents has a range of products under development based on its blood purification technology, protected by numerous patents [9]