CytoSorbents provides DrugSorb-ATR regulatory update

CytoSorbents (CTSO) provided a regulatory update on DrugSorb-ATR. CytoSorbents CytoSorbents’ flagship product, CytoSorb, is approved in the EU and distributed in over 70 countries worldwide. CytoSorbents is seeking U.S. FDA and Health Canada marketing approval of DrugSorb-ATR for antithrombotic drug removal during cardiothoracic surgery. On August 20, the company was notified that the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the company’s desired label indication for this FDA Breakthrough Device. The company plans to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication. The company expects the new application to be reviewed in an expedited fashion under the auspices of the Breakthrough Device Designation. A formal meeting with the Agency is anticipated in Q4 to confirm the requirements for the new De Novo submission. A standard regulatory decision is expected in mid-2026 following a timely De Novo submission and a typical 150-day review process. Additionally, the company has withdrawn the Request for Reconsideration in Canada and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.