CytoSorbents announces FDA has accepted De Novo medical device application

CytoSorbents (CTSO) announced the U.S. Food and Drug Administration, FDA, has accepted its De Novo medical device application for DrugSorb-ATR and initiated substantive review. The goal of DrugSorb-ATR, an investigational medical device, is to reduce the severity of perioperative bleeding in patients on ticagrelor, Brilinta, AstraZeneca (AZN), undergoing coronary artery bypass graft, CABG, surgery. The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company anticipates an FDA decision in 2025.