Cytosorbents (NASDAQ:CTSO) management said 2025 was a “transitional year” marked by record core product sales growth outside Germany, continued progress building clinical evidence, and further work to advance DrugSorb-ATR toward potential U.S. market authorization, while also reducing costs and targeting cash flow break-even in the second half of 2026.
2025 revenue rose 4% as international markets offset Germany decline
For full-year 2025, the company reported revenue of $37.1 million, up 4% year over year and flat on a constant-currency basis, according to Chief Financial Officer Peter Mariani. Management attributed the growth primarily to performance outside Germany.
Gross margin improved; restructuring and spending mix shaped results
The company posted gross margin of 71% for full-year 2025, up from 70% in 2024, and 74% in the fourth quarter, which management attributed to manufacturing efficiencies. Mariani said fourth-quarter operating efficiencies also contributed to a sequential increase in inventory levels, which increased cash burn in the quarter but was expected to reduce production spending needs in 2026.
Total operating expenses were $41.2 million for the year, described as relatively flat. Mariani said expenses included $2.5 million lower R&D spending due to lower clinical and other project spend, offset by a $1.9 million increase in SG&A tied to higher corporate spending in early 2025 and spending related to U.S. regulatory and commercial activities for DrugSorb-ATR.
Operating loss for 2025 improved 10% to $14.7 million versus $16.5 million in 2024. Adjusted EBITDA loss improved 9% to $10.5 million. Adjusted net loss was $14.2 million, or $0.23 per share, compared with an adjusted net loss of $12.7 million, or $0.23 per share, in 2024.
For the fourth quarter, revenue was $9.2 million, up 1% year over year and down 8% on a constant-currency basis. Operating expenses were $11.4 million, up from $10.1 million a year ago, including a $500,000 restructuring charge related to the company’s workforce and cost-reduction program. Mariani said the restructuring charge included approximately $400,000 of cash-based severance and $100,000 of non-cash charges. Fourth-quarter operating loss was $4.6 million, compared with $3.7 million in the prior year. Net loss improved to $5.5 million, or $0.09 per share, versus $7.6 million, or $0.14 per share, a year earlier.
Germany restructuring enters “later innings,” management says
Chief Executive Officer Dr. Phillip Chan said the company has been rebuilding Germany into a more scalable, execution-driven organization, including strengthening leadership and accountability, adding structured sales planning and performance tracking, improving customer targeting and key account focus, enhancing training, and optimizing resource allocation. He said the company is also simplifying its messaging around a clinical framework of treating the “right patient at the right time with the right dose.”
On the call’s Q&A, Chan said the new organizational structure and strategy are now largely in place, and the focus has shifted to execution. He characterized the turnaround effort as being in the “later innings,” while cautioning that improvement is expected to be incremental rather than sudden. Management pointed to early signs in the first quarter of 2026, including increased engagement and pipeline activity, and said it expects gradual improvement across the year.
New product initiatives: PuriFi and HotSwap
Chan also highlighted PuriFi, a standalone hemoperfusion pump intended to expand access to CytoSorb therapy without relying on existing dialysis infrastructure. Management said more than 100 units have been placed globally and that the system may enable earlier intervention and increased access in regions with limited dialysis infrastructure.
In response to an analyst question, management compared the PuriFi strategy to a “printer cartridge” model, where the pump may be subsidized to drive future disposable cartridge utilization. Chan said the company is not currently expecting material revenue contributions from pump sales, noting the pump can be financed through rentals, subsidies, or outright sales, but is intended to increase disposable volume over time.
The company also discussed HotSwap, described as a newly launched innovation designed to simplify and accelerate cartridge exchanges. Chan said clinician and nurse feedback has been strong and that the system is intended to minimize blood loss during exchanges and support more frequent cartridge changes.
DrugSorb-ATR: FDA path, publication milestone, and European adoption
DrugSorb-ATR remains a key pipeline program, with management emphasizing its use in patients on blood thinners such as ticagrelor (Brilinta) who require urgent coronary artery bypass graft (CABG) surgery. Chan said the company estimates an initial market opportunity of more than $300 million, with potential to expand beyond $1 billion as indications broaden.
Management said its initial de novo submission was denied, but the appeal outcome included what Chan described as two “critical positives”: no concerns regarding device safety, and alignment that a new submission can focus only on remaining open items. The company held a formal pre-submission meeting with the FDA in January 2026 and said it remains in interactive discussions to finalize requirements. Executives said they will provide timing guidance once requirements are fully defined, and emphasized they are prioritizing alignment with the FDA to avoid “surprises.”
Chan also said the STAR-T randomized controlled trial has been published in The Journal of Thoracic and Cardiovascular Surgery, which he described as the leading cardiothoracic journal in the U.S. He said the key takeaway is that DrugSorb-ATR was safe and reduced the severity of bleeding in high-risk CABG patients. Management added that real-world data from the STAR registry continues to show low rates of severe bleeding, minimal need for reoperations, and no device-related safety concerns, and said adoption in Europe is expanding.
On the balance sheet and cash outlook, Mariani said cash, cash equivalents, and restricted cash totaled $7.8 million at Dec. 31, 2025, compared with $9.1 million at the end of September. He said the fourth-quarter cash movement included $2.5 million of new debt proceeds received in November, offset by $3.8 million of net operating cash burn. Mariani added that working capital increased by roughly $1.9 million in the quarter, including a $1.5 million increase in inventory and accounts receivable.
Looking ahead, management said cost actions and working capital normalization are expected to reduce operating cash burn, with the company targeting operating cash flow break-even in the second half of 2026 while pursuing consistent revenue growth, continued improvement in Germany, and progress toward FDA market authorization for DrugSorb-ATR.
About Cytosorbents (NASDAQ:CTSO)
Cytosorbents Corporation, founded in 2011 and headquartered in Princeton, New Jersey, is a medical device company focused on critical care and extracorporeal blood purification. The company’s flagship product, CytoSorb, is a hemoadsorption cartridge designed to remove excessive inflammatory mediators such as cytokines, bilirubin and myoglobin from a patient’s blood. By targeting the molecular drivers of hyperinflammation, CytoSorb is intended to stabilize patients undergoing septic shock, cardiac surgery, trauma and organ failure.
CytoSorb has secured regulatory clearance in Europe (CE mark) and is available in more than 65 countries, with a growing presence in Asia, the Middle East and Latin America.
