CytoSorbents(CTSO) - 2024 Q2 - Quarterly Results

Financial Performance - CytoSorbents Corporation announced preliminary financial results for the quarter ended September 30, 2024, including estimated ranges for quarterly product sales and product gross margins[3] Regulatory Submissions and Approvals - The company submitted its DrugSorb™-ATR medical device De Novo marketing application to the FDA for reducing perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery[3] - DrugSorb-ATR has been granted Breakthrough Device Designation by the FDA, making it eligible for priority review[3] - The company completed its DrugSorb-ATR Health Canada Medical Device License application, pending Medical Device Single Audit Program certification[3]