CytoSorbents to file new DrugSorb-ATR De Novo application after FDA appeal upholds denial but offers expedited path

Cytosorbents Corp

FDA appeal upheld prior De Novo denial for DrugSorb-ATR, citing need for additional label-indication data; no safety issues found.
Company will file new De Novo application with new real-world data; expects expedited review under Breakthrough Device designation.
Pre-submission meeting request to FDA next month; formal meeting anticipated in Q4 2025; standard decision expected mid-2026.
Withdrew Health Canada Request for Reconsideration; will submit new application after FDA clarity.
Management focuses on core business growth, cost control, and near breakeven by end of 2025.

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