CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Results and Business Update
Rhea-AI Summary
CytoSorbents (NASDAQ: CTSO) reported preliminary, unaudited Q4 2025 revenue of approximately $9.2M and full‑year 2025 revenue of approximately $37.0M (≈4% growth vs. 2024). Q4 gross margin is expected to be 73%–75% and full‑year gross margin approximately 72%. The company surpassed 300,000 cumulative CytoSorb treatments. The pivotal STAR‑T study for DrugSorb‑ATR was accepted for publication and a Pre‑Submission meeting with the FDA is scheduled this month, with an anticipated De Novo filing by end‑Q1 2026 and a regulatory decision expected in mid‑2026. A November 13, 2025 credit amendment added $2.5M of cash and extended interest‑only terms; an additional $2.5M and further extension are conditional on FDA approval. Management expects near operating cash‑flow breakeven in Q1 2026 excluding restructuring payments.
Positive
- Full‑year 2025 revenue of $37.0M, ≈4% growth year‑over‑year
- Q4 2025 revenue of $9.2M (flat vs Q4 2024)
- Cumulative CytoSorb treatments surpassed 300,000 worldwide
- STAR‑T pivotal study accepted for publication in a cardiothoracic surgery journal
- Credit amendment added $2.5M cash and extended interest‑only period to Dec 31, 2026
Negative
- Results are preliminary and unaudited pending full audited report on March 11, 2026
- Operating cash‑flow breakeven expectation excludes restructuring payments, indicating near‑term restructuring costs
- Regulatory approval for DrugSorb‑ATR remains pending with decision anticipated mid‑2026, creating timing uncertainty
News Market Reaction
On the day this news was published, CTSO gained 4.50%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $46M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves: ELUT up 0.5%, SRTS up 7.45%, while WOK, MDAI, and TELA are down between -0.91% and -4.94%, suggesting stock-specific rather than sector-driven dynamics for CTSO.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 10 | Investor fireside chat | Positive | -12.3% | Virtual chat to discuss developments, TTM sales and DrugSorb-ATR outlook. |
| Nov 17 | Conference participation | Neutral | -0.6% | Jefferies London presentation and investor meetings announcement. |
| Nov 13 | Earnings and update | Positive | +4.2% | Q3 2025 revenue growth, improved losses, credit amendment, workforce cuts. |
| Nov 11 | Conference participation | Neutral | -3.3% | Jefferies conference attendance and one-on-one investor meetings. |
| Oct 30 | Earnings scheduling | Neutral | +0.0% | Announcement of Q3 2025 earnings release and investor call details. |
Recent news, including conferences and investor events, often saw flat-to-negative next-day moves even when updates highlighted growth and regulatory progress.
Over the past few months, CytoSorbents has focused on financial stabilization and advancing DrugSorb-ATR. Q3 2025 results on Nov 13, 2025 showed $9.5M revenue and 70% gross margin, alongside a credit agreement amendment and workforce reduction aimed at reaching operating cash-flow breakeven in Q1 2026. Subsequent releases emphasized conference participation and a virtual fireside chat, reiterating trailing $37.0M sales and a potential FDA decision by mid-2026. Today’s preliminary 2025 figures and regulatory timeline build directly on that trajectory.
Market Pulse Summary
This announcement combined preliminary 2025 financials with regulatory and operational milestones. Revenue of $9.2 million for Q4 and $37.0 million for the year, alongside gross margins around 72%, underscored stable top line and improving profitability. The planned De Novo Application for DrugSorb-ATR and accepted STAR-T publication advance the cardiac surgery franchise, while the amended credit agreement and workforce reductions support the goal of operating cash flow breakeven in Q1 2026. Investors may watch execution on these timelines.
Key Terms
de novo application regulatory
u.s. food and drug administration (fda) regulatory
cabg medical
ticagrelor medical
perioperative bleeding medical
real-world evidence regulatory
AI-generated analysis. Not financial advice.
Fourth quarter and Full-Year 2025 revenue are expected to be approximately
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
Preliminary, Unaudited Selected Fourth Quarter and Full-Year Financial Results
- Fourth quarter 2025 revenue is expected to be approximately
$9.2 million $9.2 million - Full-year 2025 revenue is expected to be approximately
$37.0 million 4% growth versus$35.6 million - Fourth quarter gross margin is expected to be in the range of
73% to75% , compared to71% in the fourth quarter of 2024, and70% in the third quarter of 2025 - Full-year gross margin is expected to be approximately
72% , compared to71% 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 $2.5 million - 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
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
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
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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Peter J. Mariani
Chief Financial Officer
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
ir@cytosorbents.com
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SOURCE Cytosorbents Corp
FAQ
What were CytoSorbents (CTSO) preliminary Q4 2025 and full‑year 2025 revenues?
When does CytoSorbents expect an FDA decision for DrugSorb‑ATR (CTSO)?
What did the November 13, 2025 credit amendment for CTSO provide?
Has CytoSorbents reported clinical validation for DrugSorb‑ATR (CTSO)?
What is CytoSorbents' margin performance in Q4 2025?
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