CytoSorbents Issues Regulatory Update On DrugSorb-ATR; Plans To File New De Novo Application

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(RTTNews) - CytoSorbents (CTSO) issued a regulatory update on DrugSorb-ATR. The company has decided to not file a final appeal with CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the company's original desired label indication. 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 plans to file a pre-submission meeting request with supporting documentation to the FDA next month. A formal meeting with the Agency is anticipated in fourth quarter of 2025 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.

The company had previously filed a Level 1 Request For Reconsideration with Health Canada. The company has withdrawn the Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.

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