CytoSorbents provides update of its appeal with FDA regarding DrugSorb-ATR

CytoSorbents (CTSO) updates the regulatory status of its appeal with the FDA for De Novo market authorization of DrugSorb-ATR. On August 14 the Company received an FDA appeal decision following its July 2025 in-person supervisory administrative review meeting with FDA under 21 CFR 10.75. The appeal was in response to an April 25 FDA denial letter of the Company’s De Novo application for DrugSorb-ATR. In the appeal decision, 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 FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR and the Company continues interactive discussions with the Agency to seek further clarity on this proposal. The FDA also noted another avenue for appeal to a higher level within the FDA, specifically with the Director of the FDA’s Center for Devices and Radiologic Health, or CDRH, that must be filed within 30 days of the appeal decision, which the Company is currently evaluating.