CytoSorbents files appeal with FDA for review of request for DrugSorb-ATR

CytoSorbents (CTSO) filed a request for supervisory review – administrative appeal – with the FDA under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25 for CytoSorbents’ DrugSorb-ATR Device. DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb-ATR for antithrombotic drug removal during cardiothoracic surgery. The denial letter identified remaining deficiencies that must be addressed before the De Novo Request can be granted and the device authorized for U.S. commercialization. In response, the company engaged with the FDA review team to clarify and discuss the remaining deficiencies and determined that a supervisory review through the administrative appeals process was the best path to resolve the remaining deficiencies. The administrative appeals process allows the Company to engage with upper management of FDA’s Center for Devices and Radiological Health in a prescribed procedure that includes a formal hearing, with a final decision typically issued approximately 60 days after the appeal is filed. The company remains confident in receiving a final regulatory decision in 2025.