Cytosorbents (NASDAQ:CTSO) reported modest revenue growth in the first quarter of 2026 while management emphasized cost controls, international commercial progress and a revised regulatory timeline for its DrugSorb-ATR device.
On the company’s earnings call, Chief Executive Officer Phillip Chan said first-quarter revenue rose 2% year over year to $8.9 million, despite what management described as temporary external headwinds. Chief Financial Officer Peter Mariani said revenue was down 7% on a constant currency basis.
International sales offset pressure in Germany and Middle East
Management pointed to strength in direct international markets outside Germany, which grew 13% year over year. Chan said that growth reflected improving physician awareness, stronger execution and increasing adoption in key accounts.
Germany remained a pressure point. Mariani said direct German sales were lower than the prior year, but management cited improved leadership, sales processes, account targeting and customer engagement with a smaller and more focused team. Chan said the company plans to selectively expand its German sales force to improve coverage and drive growth in cardiac surgery and critical care.
Distributor sales were flat year over year. The company said progress in some territories was offset by roughly $500,000 in delayed distributor orders in parts of the Middle East and neighboring regions due to geopolitical and economic instability related to the U.S.-Iran war. Chan said the company had established a subsidiary in Dubai last year and views the Middle East, including Saudi Arabia, as an opportunity due to the region’s medical infrastructure and prior interest in CytoSorb therapy.
In response to an analyst question, Mariani said some orders had been submitted and canceled at the last minute, while other orders under development did not materialize in March. He said the company believes those orders remain recoverable over time, though he did not expect an immediate snapback.
Margins remain high as company cuts costs
Gross margin was 69% in the first quarter, compared with 71% a year earlier. Mariani said the lower margin reflected a planned reduction in unit production, which helped reduce inventory to $4.8 million at quarter-end from $5.3 million at the end of 2025.
Operating expenses fell to $9.2 million from $10.1 million in the prior-year period. Mariani said the decline reflected lower research and development and clinical project spending, as well as lower compensation costs tied to a strategic headcount and cost reduction program implemented in the fourth quarter of 2025. The program reduced headcount by about 10%.
Operating loss improved approximately 22% to $3 million from $3.9 million a year earlier. Net loss, however, increased to $5.1 million, or $0.08 per share, from $1.5 million, or $0.02 per share, primarily due to non-cash foreign currency transaction impacts. Adjusted net loss improved to $3.4 million, or $0.05 per share, from $3.7 million, or $0.06 per share. Adjusted EBITDA loss improved to $2.2 million from $2.7 million.
The company ended March 31 with approximately $6.4 million in cash, cash equivalents and restricted cash, down from $7.8 million at year-end. Mariani said total cash burn in the quarter improved to $1.1 million, excluding $300,000 of restructuring-related payments. Management said it is working toward operating cash flow breakeven in the second half of 2026.
DrugSorb-ATR submission now expected in late 2026 or early 2027
Chief Medical Officer Dr. Efthymios N. Deliargyris provided an update on DrugSorb-ATR, which is being developed to remove blood thinners during cardiac surgery. He said millions of patients take direct oral anticoagulants such as Eliquis or Xarelto, or antiplatelet drugs such as Brilinta, and that patients on these therapies face increased bleeding risk when urgent surgery is needed.
Deliargyris said the Food and Drug Administration upheld a prior denial of the company’s original de novo submission in August 2025 and required additional information, primarily real-world evidence on clinical outcomes, to support the company’s desired label claim. He said the FDA did not identify device safety issues and that the company understands a future submission would focus on remaining open items.
Following a January 2026 pre-submission meeting and additional discussions, Deliargyris said the FDA requested additional mechanistic data to be included with real-world evidence in the new de novo submission. As a result, the company now expects the submission could be delayed to late 2026 or early 2027.
During the question-and-answer session, Deliargyris said the requested mechanistic data would not involve clinical outcome studies or a full clinical trial. He described the work as experimental designs intended to support the device’s mechanism of action, adding that the company is still working with the FDA to finalize the design.
Company explores parallel DOAC pathway
Deliargyris also outlined a possible second regulatory path for DrugSorb-ATR involving removal of direct oral anticoagulants during cardiac surgery. He said the company plans to submit a separate pre-submission request to the FDA within 30 days to review available data for the DOAC indication and determine what additional information may be needed to support a parallel de novo submission.
The company has previously said it intended to pursue an expanded label for DOAC removal after initial marketing approval for ticagrelor removal. Deliargyris said growing real-world evidence and publications support seeking FDA feedback sooner. He also said potential FDA approval for both Brilinta and DOAC removal in cardiac surgery could expand the U.S. total addressable market for DrugSorb-ATR to $500 million to $1 billion.
Management also highlighted the publication of main results from the STAR-T randomized clinical trial in The Journal of Thoracic and Cardiovascular Surgery. Deliargyris said the authors concluded that intraoperative DrugSorb-ATR use for ticagrelor removal is safe and can reduce the severity of bleeding after isolated CABG in patients operated on within two days of drug discontinuation.
Chan closed the call by saying the company is focused on improving efficiency, stabilizing key markets and advancing its regulatory strategy while maintaining financial discipline.
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.
