Cytosorbents (NASDAQ:CTSO) reported second-quarter revenue of $9.6 million, unchanged from a year earlier and up 9% sequentially, as higher distributor sales and growth in direct markets outside Germany were offset by weaker sales in Germany.
The company also reported improved profitability metrics and lower cash burn following restructuring and cost-cutting efforts. Chief Executive Officer Phil Chan said the quarter reflected “progress,” citing manufacturing efficiency gains, commercial changes, regulatory advancement and a reduced operating cost structure.
Operating loss narrowed 27% to $2.6 million from $3.6 million. The company reported a net loss of $4.4 million, or $0.07 per share, compared with net income of $1.9 million, or $0.03 per share, a year earlier. Mariani attributed the change largely to non-cash foreign-currency gains and losses. Adjusted net loss improved 22% to $2.9 million, while adjusted EBITDA loss improved 38% to $1.6 million.
Total cash equivalents and restricted cash stood at approximately $5.9 million as of June 30, compared with $6.3 million at the end of the first quarter. Quarterly cash burn was approximately $400,000, including roughly $200,000 of restructuring-related payments. Management said net operating cash burn was about $200,000 excluding those payments and reiterated its expectation to reach operating cash flow breakeven in the second half of 2026.
CytoSorb sales trends and Germany plans
Revenue from distributor and strategic-partner territories increased 16% year over year and 18% sequentially. Direct sales outside Germany increased 9% from a year earlier. Currency movements provided an approximately 4% positive effect on revenue versus the prior-year period.
Germany remained a challenge after restructuring reduced commercial headcount. Chan said the company plans to selectively add three to five sales representatives through early 2027 to rebuild territory coverage. He said the existing smaller sales organization is becoming more productive, while newly hired experienced representatives could begin contributing within three to six months.
The Middle East business was below management’s expectations during the first half because of disruptions related to the Iran war, although the company said physician interest in the region remained strong. Cytosorbents also cited continued placement growth for its PuriFi platform and ongoing introduction of its HotSwap technology.
DrugSorb-ATR regulatory efforts
The company provided an update on DrugSorb-ATR, its investigational cardiovascular device designed to remove antithrombotic drugs during cardiac surgery. Chief Medical Officer Makis Deliargyris said the device has received two FDA breakthrough designations, including one for removal of BRILINTA and another for removal of ELIQUIS and XARELTO during cardiac surgery.
Deliargyris reviewed results from the 140-patient STAR-T trial in patients requiring urgent cardiac surgery while taking BRILINTA. The trial met its primary safety endpoint, with the independent data safety monitoring board finding no safety concerns or additional risks associated with the device, he said.
However, the primary efficacy analysis did not achieve statistical significance. In a 111-patient CABG per-protocol analysis that management said accounted for procedural imbalances between study groups, the company reported a statistically significant win ratio of 1.59 for an endpoint focused on severe bleeding events. The company also cited a 58% relative reduction in a composite of severe bleeding or chest-tube drainage exceeding one liter, with an absolute risk reduction of 16.3 percentage points.
The FDA previously denied the company’s original De Novo application after the primary endpoint was missed and upheld that decision on appeal. Deliargyris said the agency indicated that a new clinical trial was not required and that further information could support the company’s desired labeling claim.
Cytosorbents has a pre-submission meeting scheduled with the FDA later in August to discuss additional mechanistic data. Management expects that information to include a small experimental study and real-world evidence from European use of the device. The company also plans a separate FDA pre-submission meeting later this month to discuss a potential parallel De Novo submission for direct oral anticoagulant removal.
HemoDefend-BGA strategic options
Chan also highlighted HemoDefend-BGA, a pre-commercial filter designed to remove anti-A and anti-B antibodies from plasma, potentially enabling universal plasma and other universal blood products. The company said the program has received more than $16 million in non-dilutive Department of Defense and government funding.
According to Chan, development of HemoDefend-BGA is complete and the product is undergoing device validation for human clinical studies. The company received what it described as constructive FDA feedback in July regarding an anticipated clinical pathway after a pre-IDE submission.
Cytosorbents said it is pursuing government funding, partnerships, licensing opportunities and other strategic alternatives for HemoDefend-BGA. Chan said the company does not intend to fund the program from its current financial resources, as its primary focus remains the CytoSorb business and DrugSorb-ATR.
Looking ahead, management identified four value drivers: reaching operating cash flow breakeven, restoring CytoSorb revenue growth, pursuing U.S. approval for DrugSorb-ATR and unlocking strategic value from HemoDefend-BGA. Chan also said the company intends to regain compliance with Nasdaq listing requirements and secure additional financial resources.
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.
