CTSO

MKT CAP $331.2MP/E —DIV YIELD —FCF YIELD -2.81%REV TTM —NET INCOME −$18.2MNET DEBT $12.8M52W 3.06 – 16.74SEC XBRL · TTM TO Invalid Date

How CTSO rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

54%

of sentences unchanged

Added

260

new sentences

Dropped

251

sentences removed

Length

+737

words, now 27,178

New in FY2025

TRADEMARKS This Report includes our trademarks and trade names, such as “CytoSorb,” “CytoSorb XL,” “ECOS-300CY,” “BetaSorb,” “ContrastSorb,” “DrugSorb,” “DrugSorb-ATR,” “HemoDefend-RBC,” “HemoDefend-BGA, “K+ontrol,” “VetResQ,” and “PuriFi” which are protected under applicable intellectual property laws and are the property of CytoSorbents Corporation and its subsidiaries.
The breadth of these critical illnesses include, for example, sepsis, burn injury, trauma, lung injury, liver failure, 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.
CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide, with more than 300,000 devices used cumulatively to date.
In 2020, CytoSorb received FDA EUA in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels.
CytoSorb is not yet approved, authorized, or cleared in the United States.
The Company is actively pursuing regulatory approval of DrugSorb-ATR with the 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 United States or Canada.
Upon approval, the Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million today to over $1 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic drug removal application beyond cardiac surgery and across other surgical specialties.
CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can otherwise lead to postoperative complications, including severe bleeding, shock, failure to wean from mechanical ventilation, sepsis, and multiple organ failure.
Based on numerous published studies, we believe treating the right patient, at the right time, with the right therapy of CytoSorb can lead to improved clinical outcomes.
DrugSorb-ATR installs easily into a cardiopulmonary bypass (CPB) machine and as whole blood is pumped through the cartridge during an operation, it removes the free drug from blood to reverse its antithrombotic effect. DrugSorb-ATR is initially focused on reducing the severity of perioperative bleeding in CABG patients on the anti-thrombotic drug Brilinta ® (ticagrelor, AstraZeneca) in the U.S. and Canada, where approximately 60,000 patients on this medication will need urgent cardiovascular surgery annually in those two markets each year.
Given current U.S. and Canadian prescribing trends that favor Brilinta over its competitors, Plavix (clopidogrel, BMS, Sanofi) and Effient (prasugrel, Daiichi Sankyo, Eli Lilly), and the recent availability of generic ticagrelor in the U.S. since mid-2025, the number of eligible patients could increase substantially.
In September 2024, the Company submitted its initial De Novo medical device application to the U.S.
In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its initial Medical Device License (MDL) application to Health Canada.
The Company continues to actively pursue regulatory approval of DrugSorb-ATR with the U.S.
FDA and expects to pursue regulatory approval in Canada with better visibility from the FDA.
See further discussion in ‘Cardiac Surgery’ below.
If granted or approved, DrugSorb-ATR presents a potentially valuable value proposition to multiple stakeholders.
For hospitals, decreased washout times in the hospital, fewer bleeding complications that require expensive ICU recovery, and faster throughput of revenue-generating cardiac surgeries means potentially better resource utilization, lower costs, and improved revenues while decreased adverse events help preserve a hospital’s quality rating.
Centers for Medicare and Medicaid Services (CMS), the Company expects to pursue additional reimbursement and coverage options through the New Technology Add on Payment (NTAP) and Transitional Coverage for Emerging Technologies (TCET) programs.
VetResQ is a broad-spectrum blood purification adsorber commercially available in the U.S. animal health market to help treat drug intoxication, deadly inflammation (via hemoadsorption of cytokines, bacterial toxins and other inflammatory mediators) and toxic injury in animals with critical illnesses such as drug overdose, septic shock, toxic shock syndrome, toxin-mediated diseases, pancreatitis, trauma, liver failure, heat stroke and lung injury.
Medical Device Regulation (MDR) approved advanced hemoperfusion pump that we co-developed with our original equipment manufacturing (OEM) partner, and launched in June 2024 in the E.U. and other select countries.
It can replace standard hospital blood pumps to implement our various blood purification therapies.
Clinical Studies We are focusing our company sponsored clinical research efforts on critical care and cardiac surgery applications of our technology, including the following: Country Trial Name Indication Status United States STAR-T Ticagrelor Removal During Cardiac Surgery Completed United States STAR-D Direct Anticoagulants Removal During Cardiac Surgery Terminated United States CTC Registry CytoSorb in COVID-19 patients on ECMO under EUA Completed Germany PROCYSS Refractory Septic Shock Patients Paused and amending protocol International STAR Registry Real world outcomes in antithrombotic removal Enrolling International COSMOS Registry Real world outcomes in multiple critical care applications Enrolling Critical Care In 2011, CytoSorb received EU regulatory approval under the CE Mark as an extracorporeal cytokine adsorber to be used in clinical situations where cytokines are elevated.
The German PROCYSS multicenter, randomized controlled trial evaluating the ability of CytoSorb to restore hemodynamic stability in patients with refractory septic shock is paused, pending a protocol amendment, due to slow enrollment.
The Company in collaboration with Principal Investigator and scientific committee of the trial are critically reviewing options to modify the current study design with the intent of enabling better study progress and anticipates this process to be completed in 2026.
The Registry includes study sites in Spain, Germany, Portugal, Poland, Austria, and Italy.
The Registry is contributing data for original analyses for presentations at international critical care conferences and publications in peer-reviewed journals on an ongoing basis.
In October 2025, an article was published discussing the treatment of critically ill patients under the COSMOS Registry (Ferrer R, et al.
The International Prospective CyboSorb Treatment of Critically Ill Patients (COSMOS) Registry: Interim Results From the First 150 Patients.
Journal of Intensive Medicine.) The results of the paper on the first 150 patients enrolled in the COSMOS Registry demonstrated that the use of CytoSorb was associated with improvements in lactate, creatinine, norepinephrine needs, fluid balance, and oxygenation and that observed mortality rate was favorable compared with risk-based predictions.
In December 2025, an article was published discussing the treatment of patients with severe rhabdomyolysis enrolled in the COSMOS Registry (Ferrer R, et al.
Hemoadsorption therapy in severe rhabdomyolysis: a report from the international, prospective COSMOS (CytOSorb® TreatMent of Critically ill PatientS) registry.
The results of this paper suggested that CytoSorb is an effective method to rapidly and safely reduce myoglobin levels in severe rhabdomyolysis and therefore may lead to improved kidney function.
In February 2026, an article was published discussing the treatment of 300 critically ill patients under the COSMOS Registry (Ferrer R, et al.
The international, prospective COSMOS (CytOSorb® TreatMent Of Critically Ill PatientS) Registry: results from the first 300 patients.
Journal of Anesthesia Analgesia and Critical Care ).
The results of this paper in 300 COSMOS patients extended and validated the observations from the earlier publication in 150 patients by showing that real-world CytoSorb® use as part of standard care in critically ill patients can be associated with improvements in several clinical and laboratory parameters and that observed mortality rates are lower than mortality estimates historically associated with standardized and established risk scores used in critical care.
The Registry is actively recruiting in the U.K., Germany, Austria, Belgium, Switzerland and Sweden.
Initial data outputs from the STAR Registry have already been presented at the EuroPCR and at the European Association of Cardiothoracic Surgery conferences in previous years with new analyses expected to be presented on an ongoing basis at international conferences and published in peer-reviewed journals in 2026 and beyond.

and 220 more.

Gone since FY2024

TRADEMARKS This Report includes our trademarks and trade names, such as “CytoSorb,” “CytoSorb XL,” “ECOS-300CY,” “BetaSorb,” “ContrastSorb,” “DrugSorb,” “HemoDefend-RBC,” “HemoDefend-BGA, “K+ontrol” and “VetResQ,” which are protected under applicable intellectual property laws and are the property of CytoSorbents Corporation and its subsidiaries.
The breadth of these critical illnesses include, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure.
CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in dozens of countries worldwide, with more than 270,000 devices used cumulatively to date.
CytoSorb has also received FDA EUA in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels.
CytoSorb is not yet approved in the United States.
In September 2024, the Company submitted a De Novo medical device application to the FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024.
On November 1, 2024 we received Medical Device Single Audit Program (MDSAP) certification, a key regulatory milestone that certifies compliance of our quality management system with the standard regulatory requirements of Canada, the United States, Brazil, Japan and Australia; and then promptly submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, with MDSAP certification – a requirement for the submission.
Our applications with FDA and Health Canada continue to be in substantive and interactive review, and we continue to expect regulatory decisions from both agencies in 2025.
Upon approval, the Company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million to $600 million that is anticipated to grow to $1-2 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic removal application beyond cardiac surgery and across other surgical specialties.
CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding, shock, failure to wean from mechanical ventilation, sepsis, and multiple organ failure.
Based on numerous published studies, we believe treating the right patient, at the right time, with the right therapy of CytoSorb is leading to improved clinical outcomes.
DrugSorb-ATR installs easily into a cardiopulmonary bypass (CPB) machine and as whole blood is pumped through the cartridge during an operation, it removes the free drug from blood to reverse its antithrombotic effect. DrugSorb-ATR is initially focused on reducing the severity of perioperative bleeding in CABG patients on the anti-thrombotic drug Brilinta ® (ticagrelor, AstraZeneca) in the U.S. and Canada, where approximately 60,000 patients on this medication will need urgent cardiovascular surgery annually in those two markets.
Given current U.S. and Canadian prescribing trends that favor Brilinta over its competitors, Plavix (clopidogrel, BMS, Sanofi) and Effient (prasugrel, Daiichi Sankyo, Eli Lilly), and the recent availability of generic Brilinta, the number of eligible patients could increase substantially.
In September 2024, the Company submitted a De Novo medical device application to the U.S.
In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada.
DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. If granted or approved, DrugSorb-ATR presents a potentially valuable value proposition to multiple stakeholders.
For hospitals, decreased washout times in the hospital, fewer bleeding complications that require expensive ICU recovery, and faster throughput of revenue-generating cardiac surgeries means potentially better resource utilization, lower costs, and improved revenues while decreased adverse events helps preserve a hospital’s quality rating.
Ahead of regulatory decisions for DrugSorb-ATR, we have been preparing our go-to-market strategy for the U.S. and Canada.
This initially involves the building of a limited direct sales force and a controlled rollout of DrugSorb-ATR during the first three to six months following clearance or approval, starting with the original clinical sites from the STAR-T trial.
This phased approach allows us to assess the commercial introduction process, particularly the value analysis committee (VAC) review and approval procedures for new hospital products.
Additionally, it enables us to refine our messaging and establish a core group of sales representatives who will help train new hires as we scale nationally.
The Company has identified key positions essential to building the commercial team and has initiated hiring while awaiting approvals from Health Canada and FDA.
Centers for Medicare and Medicaid Services (CMS), the Company is also pursuing additional reimbursement and coverage options through the New Technology Add on Payment (NTAP) and Transitional Coverage for Emerging Technologies (TCET) programs.
VetResQ is a broad-spectrum blood purification adsorber commercially available in the U.S. animal health market to help treat drug intoxication, deadly inflammation (via hemoadsorption of cytokines, bacterial toxins and other inflammatory mediators) and toxic injury in animals with critical illnesses such as septic shock, toxic shock syndrome, toxin-mediated diseases, pancreatitis, trauma, liver failure, heat stroke and lung injury.
Medical Device Regulation (MDR) approved advanced hemoperfusion pump that we co-developed with our original equipment manufacturer (OEM) partner, and launched in June 2024 in the E.U. and other select countries that can replace standard hospital blood pumps to implement our various blood purification therapies.
Clinical Studies We are focusing our company sponsored clinical research efforts on critical care and cardiac surgery applications of our technology, including the following: Country Trial Name Indication Status United States STAR-T Ticagrelor Removal During Cardiac Surgery Completed United States STAR-D Direct Anticoagulants Removal During Cardiac Surgery Terminated United States CTC Registry CytoSorb in COVID-19 patients on ECMO under EUA Completed Germany PROCYSS Refractory Septic Shock Patients Enrolling International STAR Registry Real world outcomes in antithrombotic removal Enrolling International COSMOS Registry Real world outcomes in multiple critical care applications Enrolling Critical Care In 2011, CytoSorb received EU regulatory approval under the CE Mark as an extracorporeal cytokine adsorber to be used in clinical situations where cytokines are elevated.
The German PROCYSS multicenter, randomized controlled trial evaluating the ability of CytoSorb to restore hemodynamic stability in patients with refractory septic shock is enrolling, however, at significantly slower rate than expected.
The Company in collaboration with Principal Investigator and scientific committee of the trial are critically reviewing options to modify the current study design with the intent of enabling better study progress and anticipate this process to be completed in 2025.
The Registry is actively enrolling in Spain, Germany, Portugal, and Italy with plans to expand in more countries in 2025.
The Registry is expected to contribute original analyses for presentations at international critical care conferences and publications in peer-reviewed journals on an ongoing basis starting in 2025.
The Registry is actively recruiting in the U.K., Germany, Austria, Belgium and Sweden and is planned to expand to additional countries in 2025.
Initial data outputs from the STAR Registry have already been presented at the EuroPCR and at the European Association of Cardiothoracic Surgery conferences in previous years with new analyses expected to be presented on an ongoing basis at international conferences and published in peer-reviewed journals in 2025 and beyond.
In July 2021, we received full FDA approval of an Investigational Device Exemption (IDE) application to conduct a double-blind, randomized, controlled clinical study in 120 patients entitled, “ S afe and T imely A ntithrombotic R emoval – T icagrelor ( STAR-T ),” in the United States to support FDA marketing approval.
In October 2021, we also received full FDA approval of an Investigational Device Exemption (IDE) application to conduct a double-blind, randomized, controlled clinical study for up to 120 patients entitled, “ S afe and T imely A ntithrombotic R emoval – D irect Oral Anticoagulants ( STAR-D ),” in the United States to support FDA marketing approval.
Further discussions with the FDA to determine an appropriate label expansion strategy to include the removal of DOACs will ensue following the completion of the ongoing review of the current FDA application for DrugSorb-ATR for the removal of ticagrelor.
Since 2012, we have been awarded an aggregate of approximately $42.3 million in grants, contracts, and other non-dilutive funding from DARPA ($3.8M over 5 years), the U.S.
Air Force program ($75K), New Jersey Technology Business Tax Certificate Program for research related expenses ($8.6M), and others to further develop our technologies for sepsis, trauma and burn injury, and blood transfusions, respectively.
Commercial and Research Partners Fresenius Medical Care AG In December 2014, we established a multi-country partnership with Fresenius Medical Care to commercialize CytoSorb in France, Poland, Sweden, Denmark, Norway, and Finland.
Fresenius received exclusive distribution rights and supported clinical development.
A revised three-year agreement (effective January 2017) extended Fresenius’ exclusive distribution for critical care applications through 2019 and included guaranteed minimum quarterly orders.

and 211 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch CTSO. Know when insiders buy.

One email the day a filing lands. Free.