CytoSorbents posts flat Q4 revenue of $9.2 million, plans FDA filing

CytoSorbents Corporation (NASDAQ: CTSO) reported preliminary fourth quarter 2025 revenue of approximately $9.2 million, unchanged from the same period in 2024. Full-year 2025 revenue reached approximately $37.0 million, representing 4% growth compared to $35.6 million in 2024.

The medical device company reported fourth quarter gross margins in the range of 73% to 75%, up from 71% in the fourth quarter of 2024 and 70% in the third quarter of 2025. Full-year gross margin improved to approximately 72% from 71% in 2024.

The company scheduled a pre-submission meeting with the FDA this month to discuss regulatory requirements for a new De Novo Application for its DrugSorb-ATR device. The investigational medical device is designed to reduce bleeding severity in patients taking ticagrelor who undergo coronary artery bypass graft surgery. CytoSorbents expects to file the De Novo Application by the end of the first quarter of 2026, with a regulatory decision anticipated in mid-2026.

Results from the pivotal STAR-T study for DrugSorb-ATR have been accepted for publication in a cardiac surgery journal. The company said the publication is currently in press and should be available online soon.

CytoSorbents announced that cumulative CytoSorb treatments have surpassed 300,000 worldwide. The company's flagship CytoSorb product is approved in the European Union and distributed in over 70 countries.

In November 2025, the company amended its credit agreement, adding $2.5 million in cash and extending the interest-only period through December 31, 2026. The amendment provides for an additional $2.5 million and extension to June 30, 2027 upon FDA approval of DrugSorb-ATR.

The company implemented a workforce and cost reduction program in the fourth quarter and expects to be approximately cash-flow breakeven, excluding restructuring payments, in the first quarter of 2026. Management will host investor meetings in San Francisco during J.P. Morgan Healthcare Conference week.

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