CytoSorbents Provides Regulatory Update on DrugSorb-ATR

CytoSorbents Corporation (NASDAQ: CTSO) has provided a regulatory update on its DrugSorb™-ATR device. The U.S. Food and Drug Administration (FDA) upheld its prior De Novo denial decision but proposed an expedited path forward for market authorization. The Company has decided not to file a final appeal with the FDA’s Center for Devices and Radiologic Health (CDRH) due to positive feedback from FDA upper management. Instead, CytoSorbents plans to file a new De Novo application with additional real-world data to support its desired label indication. The Company expects the new application to be reviewed in an expedited fashion under the Breakthrough Device Designation. A pre-submission meeting with the FDA is anticipated in Q4 2025, with a standard regulatory decision expected in mid-2026. The Company has also withdrawn its Request for Reconsideration with Health Canada and will provide a new Medical Device License application with improved visibility from the FDA. CytoSorbents remains committed to securing marketing authorization for DrugSorb-ATR while focusing on growth in its core business.