What is the story about?
What's Happening?
CytoSorbents Corporation has received feedback from the U.S. Food and Drug Administration (FDA) regarding its DrugSorb-ATR device, which is designed to reduce perioperative bleeding in high-risk surgeries. The FDA upheld its previous denial of the De Novo application, citing the need for additional information to support the device's label indication. However, the FDA proposed an expedited path forward for market authorization. CytoSorbents plans to file a new De Novo application with additional real-world data to support its desired label indication. The company has decided not to file a final appeal with the FDA's Center for Devices and Radiologic Health, opting instead to pursue the expedited path suggested by the FDA.
Why It's Important?
The development of DrugSorb-ATR is significant as it addresses a major unmet medical need by potentially reducing the severity of bleeding in surgeries involving blood thinners. The FDA's feedback and the proposed expedited path could accelerate the availability of this device in the U.S. market, benefiting patients undergoing high-risk surgeries. The device has already received FDA Breakthrough Device Designation, which underscores its potential impact on patient care. Successful approval could also enhance CytoSorbents' market position and drive growth in its core business.
What's Next?
CytoSorbents plans to file a pre-submission meeting request with the FDA to finalize the requirements for the new De Novo submission. A formal meeting with the FDA is anticipated in the fourth quarter of 2025. The company expects a regulatory decision by mid-2026, following a typical 150-day review process. Additionally, CytoSorbents has withdrawn its request for reconsideration with Health Canada and will submit a new application once clarity is received from the FDA.
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