Core Insights - CytoSorbents Corporation is focused on bringing DrugSorb™-ATR to market as a solution for preventing life-threatening bleeding in CABG patients treated with Brilinta® [3] - The FDA issued a denial letter for the De Novo Request for DrugSorb-ATR, citing deficiencies that need to be addressed before commercialization can proceed [2] - The company is committed to resolving the issues with the FDA and anticipates a final regulatory decision in 2025 [3] Company Overview - CytoSorbents Corporation specializes in blood purification therapies for critical conditions in intensive care and cardiac surgery [4] - The company’s technologies utilize biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios [4] - CytoSorbents has a lead product, CytoSorb®, which is approved in the EU and used in over 70 countries, with over 270,000 devices utilized to date [5] Product Development - DrugSorb-ATR is an investigational device aimed at reducing perioperative bleeding in high-risk surgeries due to blood thinners [6] - The device has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants [6] - The company submitted a De Novo Request for DrugSorb-ATR in September 2024, which was accepted for review in October 2024 [6] Regulatory Challenges - The FDA's denial letter highlighted remaining deficiencies that must be resolved for DrugSorb-ATR to be authorized for commercialization [2] - CytoSorbents plans to engage in ongoing discussions with the FDA and will file a formal appeal if necessary [2]

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]