CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Results and Business Update

Fourth quarter and Full-Year 2025 revenue are expected to be approximately $9.2 million and $37.0 million, respectively, with expected Q4 gross margins in the range of 73% to 75%

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 December 31, 2026. The amendment also provides for an additional $2.5 million of cash and an additional extension of the interest-only period to June 30, 2027 with DrugSorb®-ATR FDA marketing approval.
• Further, the Company implemented a previously announced strategic workforce and cost reduction program in the fourth quarter and expects to be approximately cash-flow breakeven (excluding restructuring payments) for the first quarter of 2026.

"First, we are very pleased with the acceptance of the STAR-T study results for publication in a prestigious cardiothoracic surgery journal, reflecting the interest and clinical relevance of our technology within the cardiac surgical community. We expect the publication to be available online very soon," commented Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "Next, we look forward to our scheduled Pre-Submission Meeting with the FDA later this month to discuss the additional information planned for inclusion in our upcoming De Novo filing. Since the initial De Novo submission in September 2024, substantial additional new real-world data have become available. These data demonstrate that the use of our device in routine clinical practice for patients on ticagrelor undergoing urgent CABG surgery is associated with lower rates of severe bleeding compared with rates previously reported in the literature when the device is not used. We believe this new information is consistent with recent FDA guidance emphasizing the value of real-world evidence in supporting benefit-risk assessments for investigational devices and, when combined with our STAR-T results, further strengthen the overall evidence base for our upcoming submission. Pending alignment with the FDA and submission of the new, updated De Novo submission, we continue to anticipate a regulatory decision in mid-2026. We look forward to completing the regulatory process and bringing DrugSorb®-ATR to market as a potential solution to this critical unmet need in cardiac surgery."

"Meanwhile, we continue to progress with our operational changes designed to drive sustained, profitable growth in the long run. We have strengthened our balance sheet through an amendment of our credit facility. We are in the midst of implementing numerous process improvements to return our German commercial team to growth. We expect that these initiatives along with our recently implemented global strategic Workforce and Cost Reduction program will accelerate our path to profitability, and we continue to expect to be approximately operating cash flow break-even in the first quarter of 2026." 

Dr. Chan concluded, "Finally, we are pleased to have surpassed the milestone of 300,000 CytoSorb treatments delivered cumulatively worldwide, where the therapy has been used to help critically ill and cardiac surgery patients in a wide multitude of clinical applications. We are thankful for the opportunity to work with a global community of clinicians and scientists committed to solving major unmet medical needs like sepsis and septic shock, acute liver failure, acute respiratory distress syndrome, perioperative bleeding caused by blood thinners, and many other life-threatening conditions afflicting millions of people each year." 

The results disclosed in this press release are preliminary and unaudited. The Company expects to report full, audited results for the fourth quarter and year ended December 31, 2025, on March 11, 2026.

Management will host in-person investor meetings in San Francisco alongside the 44^th Annual J.P. Morgan Healthcare Conference being held January 12-15, 2025, in San Francisco, CA. To schedule a meeting with Dr. Phillip Chan, Chief Executive Officer, and Peter J. Mariani, Chief Financial Officer, please send requests to [email protected].

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine storm and cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.

CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. CytoSorb® was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb® has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb® is not yet approved or cleared in the United States.

In the U.S. and Canada, CytoSorbents is developing the DrugSorb®-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb®, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is actively pursuing regulatory approval of DrugSorb®-ATR with the U.S. FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA. DrugSorb®-ATR is not yet granted or approved in either the U.S. or Canada.

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb®, ContrastSorb, and others. For more information, please visit the Company's website at https://ir.cytosorbents.com/ and follow us on Facebook and X and LinkedIn. 

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve cash-flow break-even in the first quarter of 2026, our ability to appropriately finance the Company, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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U.S. Company Contact: 
Peter J. Mariani
Chief Financial Officer
[email protected] 

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
[email protected] 

SOURCE Cytosorbents Corp