Michael Sarcone

Thomas Kerr

Michael Kim

Sean Lee

Xun Lee

- CytoSorbents Corporation announced a regulatory update on its DrugSorb-ATR device, noting that the **FDA found no issues with device safety** but upheld a prior De Novo denial due to the need for additional information to support the desired label indication.  **[1175151_0000929638-25-003494_exhbit99-1.htm:1]** 
- The company has decided **not to file a final appeal** with the FDA's CDRH and instead plans to submit a **new De Novo application** incorporating analyses of new real-world data.  **[1175151_0000929638-25-003494_exhbit99-1.htm:1]** 
- A formal meeting with the FDA to confirm requirements for the new submission is anticipated in **Q4 2025**, with a standard regulatory decision expected in **mid-2026** following a timely submission and typical 150-day review process.  **[1175151_0000929638-25-003494_exhbit99-1.htm:1]** 
- CytoSorbents has also **withdrawn its Request for Reconsideration with Health Canada** for DrugSorb-ATR, intending to provide a new Medical Device License application once there is better clarity from the U.S. FDA.  **[1175151_0000929638-25-003494_exhbit99-1.htm:2]** **[1175151_0000929638-25-003494_exhbit99-1.htm:3]**

CytoSorbents Provides DrugSorb-ATR Regulatory Update

- CytoSorbents received an FDA appeal decision on **August 20, 2025**, upholding the denial of its DrugSorb-ATR De Novo application but proactively proposing an expedited path forward for market authorization.  **[1175151_20250916NY74492:0]** 
- The company plans to file a **new De Novo application** with additional **real-world data** to support its desired label indication, expecting an expedited review under its Breakthrough Device Designation.  **[1175151_20250916NY74492:0]** 
- A pre-submission meeting request with the FDA is planned for **next month**, with a formal meeting anticipated in **Q4 2025** to confirm requirements, and a standard regulatory decision expected by **mid-2026**.  **[1175151_20250916NY74492:0]** 
- CytoSorbents has withdrawn its Health Canada "Request For Reconsideration" for DrugSorb-ATR and will provide a new Medical Device License application once there is better clarity from the FDA.  **[1175151_20250916NY74492:1]**

Cytosorbents (CTSO)