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CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.
The denial letter identified remaining deficiencies that must be addressed before the De Novo Request can be granted and the device authorized for U.S. commercialization. In response, the Company engaged with the FDA review team to clarify and discuss the remaining deficiencies. After careful consultation with its regulatory counsel and advisors, the Company determined that a supervisory review through the administrative appeals process was the best path to resolve the remaining deficiencies.
The administrative appeals process allows the Company to engage with upper management of FDA's Center for Devices and Radiological Health (CDRH) in a prescribed procedure that includes a formal hearing, with a final decision typically issued approximately 60 days after the appeal is filed.
CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. As previously disclosed, Health Canada indicated that application reviews are delayed beyond their target Market Authorization Times (MAT) due to a backlog but is committed to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025.
Posted In: CTSO
