DrugSorb®-ATR De Novo Pre-Submission Meeting scheduled with the FDA this month, with anticipated De Novo Application filing this quarter and regulatory decision in mid-2026
Results of the pivotal STAR-T study for DrugSorb®-ATR have recently been accepted for publication in a top cardiac surgery journal
Management will host in-person investor meetings in San Francisco during J.P. Morgan Healthcare Conference week
PRINCETON, N.J., Jan. 12, 2026 /PRNewswire/ -- 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 preliminary unaudited fourth quarter and full-year 2025 financial results and business update.
Preliminary, Unaudited Selected Fourth Quarter and Full-Year Financial Results
Fourth quarter 2025 revenue is expected to be approximately $9.2 million compared to $9.2 million in the fourth quarter of 2024
Full-year 2025 revenue is expected to be approximately $37.0 million, representing approximately 4% growth versus $35.6 million for the full-year 2024
Fourth quarter gross margin is expected to be in the range of 73% to 75%, compared to 71% in the fourth quarter of 2024, and 70% in the third quarter of 2025
Full-year gross margin is expected to be approximately 72%, compared to 71% for full-year 2024
Recent Business Updates
Cumulative CytoSorb treatments have now surpassed 300,000 worldwide.
Results of the pivotal STAR-T study for DrugSorb®-ATR have recently been accepted for publication in a top cardiac surgery journal. The publication is currently in press and should be available online soon.
The Company has scheduled a Pre-Submission Meeting this month with the U.S. Food and Drug Administration (FDA) to confirm regulatory requirements for a new De Novo Application for DrugSorb®-ATR, the Company's investigational medical device to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. Pending the outcome of the Pre-Submission Meeting, the Company expects to file a new De Novo Application by the end of the first quarter of 2026.
As previously announced, on November 13, 2025, the Company amended its credit agreement which strengthened its balance sheet with an additional $2.5 million of cash and extended the interest-only-period through
