CytoSorbents is commercializing its E.U. approved CytoSorb blood purification technology to treat life-threatening conditions in the intensive care unit and cardiac surgery. The company also seeks U.S. and Canadian approval of a second product, DrugSorb-ATR, to reduce perioperative bleeding risk in patients on blood thinners in cardiac surgery. Based on the results of its STAR-T trial, the company submitted for FDA De Novo approval and Health Canada licensure in late 2024 and is currently navigating the appeal process with both agencies. Final regulatory decisions are expected in 2025. Based on $36.1 million in high margin TTM revenue and the near-term potential of DrugSorb-ATR, we believe CTSO stock to be significantly undervalued at this time.
20 Aug 2025
CTSO: CytoSorbents announced the De Novo denial on DrugSorb-ATR was upheld by the FDA. However, a path to approval was also provided by the agency. The decision also found no safety issues with DrugSorb-ATR.
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CTSO: CytoSorbents announced the De Novo denial on DrugSorb-ATR was upheld by the FDA. However, a path to approval was also provided by the agency. The decision also found no safety issues with DrugSorb-ATR.
- Published:
20 Aug 2025 -
Author:
Tom Kerr -
Pages:
7 -
CytoSorbents is commercializing its E.U. approved CytoSorb blood purification technology to treat life-threatening conditions in the intensive care unit and cardiac surgery. The company also seeks U.S. and Canadian approval of a second product, DrugSorb-ATR, to reduce perioperative bleeding risk in patients on blood thinners in cardiac surgery. Based on the results of its STAR-T trial, the company submitted for FDA De Novo approval and Health Canada licensure in late 2024 and is currently navigating the appeal process with both agencies. Final regulatory decisions are expected in 2025. Based on $36.1 million in high margin TTM revenue and the near-term potential of DrugSorb-ATR, we believe CTSO stock to be significantly undervalued at this time.