What changed in this filing

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Item 1. Business

2026-03-30 compared with 2025-03-31 · 183 added, 137 removed, 462 unchanged (41% of the section changed)

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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 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.

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.

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 dozens of countries worldwide, with more than 270,000 devices used cumulatively to date.

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.

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 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 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.

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.

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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 procedures.

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.

DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

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 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.

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.

We believe that DrugSorb-ATR has the potential to become an “all-in-one” countermeasure for these agents.

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CytoSorbents commercializes three different cartridges based on this bead technology.

CytoSorb for critical care and cardiac surgery and ECOS-300CY for ex vivo organ perfusion in transplant are approved in the E.U., while VetResQ for emergency and critical care in animals is commercialized primarily in the U.S.

CytoSorb for critical care and cardiac surgery and ECOS-300CY for ex vivo organ perfusion in transplant are approved in the E.U., while VetResQ

for emergency and critical care in animals is commercialized primarily in the U.S.

CytoSorbents is currently seeking U.S.

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in trauma and critical illness).

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.

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.

CytoSorb is also used in cardiac surgery applications to reduce inflammatory mediators and blood thinners, targeting a reduction in complications of cardiac surgery like sepsis, bleeding, and shock.

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Because of this, CytoSorb is “Expanding the Dimension of Blood Purification™” in critical care and cardiac surgery, treating inflammation and also other conditions where toxic substances can cause harm, while restoring balance.

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.

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.

In particular, when used early and aggressively on a hyperinflamed patient with worsening organ failure, CytoSorb treatment is associated with the reversal or prevention of many complications such as shock, acute respiratory distress syndrome (ARDS), and kidney failure.

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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.

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 Brilinta, the number of eligible patients could increase substantially.

since mid-2025, the number of eligible patients could increase substantially.

Coronary Artery Bypass Grafting (CABG) is the most common type of cardiac surgery worldwide, and per the European Multicenter Study on CABG (E-CABG) Registry, the rate of severe bleeding is more than 3 times higher when patients undergo CABG within two days of the last dose of Brilinta, compared to those who underwent a 4-5 day washout.

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and Canada pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) trial and European STAR Registry suggest the use of CytoSorbents’ technology enables CABG patients to safely undergo surgery within 2 days of the last dose of Brilinta without the associated increased bleeding risk.

CytoSorbents’ technology was granted two FDA Breakthrough Device Designations, one for the removal of ticagrelor (2020) and another (2021) for the removal of the direct oral

anticoagulants (DOACs) Eliquis (apixaban, Pfizer, BMS) and Xarelto (rivaroxaban, Janssen, Bayer).

In September 2024, the Company submitted a De Novo medical device application to the U.S.

CytoSorbents’ technology was granted two FDA Breakthrough Device Designations, one for the removal of ticagrelor (2020) and another (2021) for the removal of the direct oral anticoagulants (DOACs) Eliquis (apixaban, Pfizer, BMS) and Xarelto (rivaroxaban, Janssen, Bayer).

In September 2024, the Company submitted its initial De Novo medical device application to the U.S.

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.

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.

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.

DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

See further discussion in ‘Cardiac Surgery’ below.

If granted or approved, DrugSorb-ATR presents a potentially valuable value proposition to multiple stakeholders.

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For surgeons, it can potentially help get these patients into the operating room faster, while helping to avoid severe intra and postoperative bleeding complications that can be a nightmare scenario for surgeons while negatively impacting their surgical outcomes and the scheduling of new patient surgeries.

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.

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.

Given that DrugSorb-ATR is an FDA Breakthrough Device and that a large percentage of the target population fall under the U.S.

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.

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.

Though we believe these additional programs are not necessary to sell DrugSorb, we believe they could enhance what we believe is an already strong value proposition based on expected clinical benefit and cost savings.

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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.

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.

VetResQ is based upon an equivalent polymer technology to CytoSorb and is configured in three different sized cartridges (50, 150 and 300mL) to accommodate treatment of small, medium, and large animals such as cats, dogs, and high-value animals such as foals and horses.

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PuriFi is an E.U.

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.

The PuriFi peristaltic blood pump features a number of differentiating innovations that separate it from other standard hemoperfusion pumps including a pre-assembled adult and

pediatric blood line kit, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen graphical user interface with a step-by-step user-friendly set-up guide, optional blood warming, and a rapid 10-minute set-up time.

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.

The PuriFi peristaltic blood pump features a number of differentiating innovations that separate it from other standard hemoperfusion pumps including a pre-assembled adult and pediatric blood line kit, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen graphical user interface with a step-by-step user-friendly set-up guide, optional blood warming, and a rapid 10-minute set-up time.

Together, these unique features enable an easy and rapid way to administer CytoSorbents’ blood purification technologies like CytoSorb and VetResQ for critically ill and cardiac surgery patients.

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Refractory Septic Shock Patients

Paused and amending protocol

International

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Together, the goal of this dual-therapy strategy is to give the lungs a chance to recover and heal, a pre-requisite for weaning off mechanical ventilation and ECMO.

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 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 international COSMOS Registry was designed to capture real world outcomes and device utilization patterns across multiple critical care indications including but not limited to sepsis, acute respiratory failure, postoperative vasoplegia, rhabdomyolysis, acute liver failure, and acute pancreatitis.

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 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.

Renal Failure ).

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.

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.

Cardiac Surgery

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The international S afe and T imely A ntithrombotic R emoval ( STAR ) Registry is designed to capture real world clinical and health economic outcomes with intraoperative antithrombotic drug removal.

The Registry is actively recruiting in the U.K., Germany, Austria, Belgium and Sweden and is planned to expand to additional countries in 2025.

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.

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 August 2024, an article was published discussing the initial results of patients on antithrombotic drugs undergoing cardiac surgery under the STAR Registry (Schmoeckel M, et al.

Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery:

initial report of the international safe and timely antithrombotic removal (STAR) registry.

Journal of Thrombosis Thrombolysis ).

This initial report of the ongoing STAR registry showed that the intraoperative use of CytoSorb is simple and safe and may potentially mitigate the expected high bleeding risk of patients on antithrombotic drugs undergoing cardiac surgery before completion of the recommended washout period.

In January 2025, an article was published discussing treatment of patients on direct oral anticoagulants (DOAC) under the STAR Registry (Schmoeckel M, et al.

Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery:

interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry.

Journal of Cardiothoracic Surgery ).

This interim report of the ongoing STAR-registry showed that in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the intraoperative use of CytoSorb is associated with low rates of severe perioperative bleeding complications.

In August 2025, an article was published discussing the treatment of patients on antithrombotic drugs undergoing heart transplantation under the STAR Registry (Schmitto J, et al.

Intraoperative antithrombotic drug removal during heart transplantation:

A case series from the International Safe and Timely Antithrombotic Removal (STAR) registry.

Journal of Heart and Lung Transplantation Open ).

This case series from the ongoing STAR registry showed that intraoperative antithrombotic removal with CytoSorb is simple, safe and potentially effective in minimizing serious perioperative bleeding complications in patients on ticagrelor or DOAC undergoing heart transplantation.

In January 2026, an article was published discussing the treatment of patients on ticagrelor undergoing coronary artery bypass grafting (CABG) surgery (Storey RF, et al.

Early CABG with intraoperative hemoadsorption in patients on ticagrelor:

Real-world data from the international Safe and Timely Antithrombotic Removal (STAR) registry.

Cardiovascular Revascularization Medicine ).

This paper on 102 patients on ticagrelor undergoing urgent CABG showed that intraoperative ticagrelor removal with CytoSorb is simple, safe and may help reduce ticagrelor-related bleeding in patients operated before completing the guideline recommended 3-day washout.

In July 2021, we received FDA Investigational Device Exemption (IDE) approval 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.

This was done under the previously announced FDA Breakthrough Device Designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding during urgent cardiac surgery.

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The Company submitted the DrugSorb-ATR medical device De Novo marketing application to the FDA on September 27, 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 promptly submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024.

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.

On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device authorized for commercialization in the U.S.

The Company filed an appeal of the decision through the formal appeal process with the FDA.

In July 2025, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75.

The appeal hearing included FDA senior leadership, Company management and our external surgical experts.

In August 2025, the Company received an FDA appeal decision where the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company’s desired label indication.

Additionally, the FDA proactively proposed a potential expedited path forward for market authorization but noted the Company could also appeal to a final higher level within the FDA with the Director of the FDA’s Center for Devices and Radiologic Health (CDRH).

In September 2025, the Company announced that it decided to not file a final appeal with the CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the Company’s original desired label indication.

The Company expects to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication.

As part of the resubmission process, the Company filed a pre-submission meeting request with supporting documentation to the FDA in November 2025.

The Company conducted a formal pre-submission meeting with the FDA in late January 2026 and continues to engage with the FDA to clarify and confirm the requirements for the new De Novo submission.

The interactive discussions regarding the information to be included in the new submission are ongoing, and the Company expects to provide an update of the anticipated timing for the new submission once these interactive discussions with the FDA on the final requirements are complete.

Following the new De Novo submission, a regulatory decision would be expected following a typical 150-day review process but may be accelerated or extended depending on interactive discussions with the FDA related to submission questions.

On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization.

On September 16, 2025 the Company announced that it had timely filed a Level 1 “Request For Reconsideration” with Health Canada.

However, following interactive discussions with the Medical Devices Directorate Bureau Director and the Company’s Canadian regulatory counsel, it was recommended that any subsequent review of DrugSorb-ATR in Canada be delayed until better clarity was received from the FDA.

As such, the Company withdrew the Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.

In January 2026, the results of the STAR-T trial entitled, “Randomized, Sham-Controlled Trial of Intraoperative Ticagrelor Removal to Reduce Perioperative Bleeding” were published in the leading U.S.

peer-reviewed cardiothoracic surgery journal, the Journal of Thoracic and Cardiovascular Surgery.

(Mack MJ, et al.

on behalf of the STAR-T Investigators, J Thorac Cardiovasc Surg ).

This paper with the main results of the double-blind, randomized STAR-T trial showed that the intraoperative use of DrugSorb-ATR is safe in patients undergoing cardiac surgery within 2 days of ticagrelor discontinuation and that among patients undergoing urgent, nondeferrable CABG surgery the device was associated with significant reductions in the severity of perioperative bleeding compared with controls.

In October 2021, we also received FDA Investigational Device Exemption (IDE) approval 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.

This was done under the previously announced 2 nd FDA Breakthrough Device Designation granted for our DrugSorb-ATR Antithrombotic Removal System.

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The STAR-D study was initiated, but the Company ultimately decided to place it on hold for business reasons, specifically related to prioritization and focused resource allocation to the completion of the STAR-T study and the subsequent regulatory submissions to FDA and Health Canada.

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.

Research and Development

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and $4.3M JWMRP), Lipopolysaccharide Adsorption In Sepsis (National Institution of General Medical Sciences $282K), 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.

Air Force program ($75K), New Jersey Technology Business Tax Certificate Program for research related expenses ($10.3M), and others to further develop our technologies for sepsis, trauma and burn injury, and blood transfusions, respectively.

Some payments are based on achieving certain technology milestones.

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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.

Additionally, we entered into a comprehensive co-marketing agreement with Fresenius.

Under the terms of the co-marketing agreement, CytoSorbents and Fresenius agreed to jointly market CytoSorb to Fresenius’ critical care customer base in all countries where CytoSorb was being actively commercialized.

CytoSorb continued to be sold by our direct sales force or through our international network of distributors and partners, while Fresenius sold all ancillary products to their customers.

Fresenius further provided written endorsements of CytoSorb for use with their multiFiltrate and multiFiltratePRO acute care dialysis machines that could be used by us and our distribution partners to promote CytoSorb worldwide.

In December 2018, the Company amended its 2014 Fresenius distribution agreement, granting exclusivity for certain applications in France, Czech Republic, and Finland.

In 2019, several countries transitioned to co-marketing, and minimum purchase requirements were removed.

The aforementioned exclusive agreements became non-exclusive in January 2022.

In addition, also in December 2018 and in 2020, we entered into agreements to expand the partnership with Fresenius into South Korea, Mexico, Colombia and Ecuador.

The Company has developed various multi-country distribution and/or co-marketing agreements with Fresneius Medical Care AG dating back to December 2014.

Over the years, these agreements have included partnerships to support the commercialization of CytoSorb in various countries including, France, Poland, Sweden, Denmark, Norway, Czech Republic, Finland, South Korea, Mexico, Colombia and Ecuador.

In August 2022, CytoSorbents and Fresenius expanded their partnership with a new Marketing Agreement to promote CytoSorb globally (excluding the US) for critical care.

Fresenius would promote CytoSorb as the featured solution for cytokine, bilirubin, and myoglobin on its critical care platforms worldwide with the exception of the U.S., in a comprehensive marketing campaign.

Fresenius would promote CytoSorb as the featured solution for cytokine, bilirubin, and myoglobin removal on its critical care platforms worldwide with the exception of the U.S., in a comprehensive marketing campaign.

The Marketing Agreement also included the certification of compatibility of CytoSorb for usage on Fresenius’ current critical care platforms and provided for potential new collaborations on novel future innovations.

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Under the terms of this agreement, CytoSorbents would pay royalties on sales to offset program-specific marketing costs.

Due to delays in the full implementation of this Marketing Agreement, no royalties were paid under this agreement in 2024 or 2023.

Due to delays in the full implementation of this Marketing Agreement, no royalties were earned or paid under this agreement in 2024 or 2025.

Aferetica s.r.l.

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Terumo Cardiovascular Group

On January 1, 2024, we entered into a second amended and restated agreement to the original distribution agreement from October 2016.

On January 1, 2024, we entered into a second amended and restated agreement to an original distribution agreement from October 2016.

Under the terms of this amended and restated agreement, Terumo received non-exclusive distribution rights in France to promote and sell the CytoSorb CPB procedure pack for intra-operative use during cardiac surgery at specifically named hospitals in France.

This amended and restated agreement allowed the Company to sell directly to other hospital customers in France for the cardiac surgery application.

Financial terms of this agreement have not been disclosed.

The agreement terminated on December 31, 2023 and is currently under re-negotiation.

The agreement expired on January 1, 2025;

however Terumo and the Company are continuing to operate under those terms as they negotiate an updated agreement.

Braun Avitum AG

In March 2021, we announced announce the launch of a global co-marketing agreement with B.

In March 2021, we announced the launch of a global co-marketing agreement with B.

Braun Avitum AG, one of the world’s leading manufacturers of medical devices and pharmaceutical products and services, to promote the use of CytoSorb ® with B.

Braun’s latest OMNI ® continuous blood purification platform and OMNIset ® Plus bloodline set (set version 3.0 or higher).

CytoSorb ® adsorber is used in critical care for the extracorporeal removal of cytokines and inflammatory mediators from the bloodstream and can be operated with the B.

The CytoSorb ®

adsorber is used in critical care for the extracorporeal removal of cytokines and inflammatory mediators from the bloodstream and can be operated with the B.

Braun OMNI ® acute dialysis machine.

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market is specifically excluded).

Financial terms of this agreement have not been disclosed.

The Advisory Boards

From time to time our management meets with scientific advisors to obtain expert opinions on basic science, critical care medicine and cardiac surgery.

We compensate all our SAB members according to fair market value and reimburse them for their travel expenses when attending meetings in person.

We compensate all our Scientific Advisory Board (SAB) members according to fair market value and reimburse them for their travel expenses when attending meetings in person.

Royalty Agreement

In August 2003, in order to induce Guillermina Vega Montiel, a principal member of RenalTech International, LLC at the time, to make a $4 million investment in RenalTech International, LLC, Ms.

Montiel was granted a perpetual royalty (the “Royalty”) equal to three percent of all gross revenues, license fees, or sales of CytoSorb intellectual property received by us from sales or license of CytoSorb in the applications of sepsis, cardiopulmonary bypass surgery, organ donor, chemotherapy and inflammation control.

In addition, for her investment, Ms.

Montiel received 1,230,770 membership units of RenalTech International, LLC.

Such membership units ultimately were converted into and became 7,420 shares of our common stock following our June 30, 2006 merger.

In February 2017, all rights, title and interest to the Royalty were assigned to The Robert Shipley Living Trust.

The Company has been party to an agreement whereby it pays a perpetual royalty of three percent on sales of its technology since 2003.

In November 2022, all rights, title and interest to the Royalty was assigned to ROKK, LLC.

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Under the Amended and Restated Agreement, the term “Covered Product” means the Company’s flagship product, CytoSorb, together with the currently commercialized versions of VetResQ and ECOS-300CY, as well as the versions of DrugSorb and DrugSorb-ATR that have been evaluated in human clinical trials, in each case as of the date of the Amended and Restated Agreement.

For the year ended December 31, 2024 we have recorded royalty costs of approximately $1,060,000.

For the year ended December 31, 2025, we recorded royalty costs of approximately $1.1 million.

License Agreement

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Under the terms of the Settlement Agreement, we have agreed to pay Purolite royalties of 2.5% to 5% on the sale of those of our products, if and when those products are sold commercially, that are used in direct contact with blood or, in certain cases, in direct contact with a physiological fluid other than blood.

The royalty payments provided for under the Settlement Agreement would apply to our currently envisioned CytoSorb, VetResQ, and BetaSorb products.

For the year ended December 31, 2024 per the terms of the license agreement we have recorded royalty costs of approximately $809,000.

The royalty payments provided for under the Settlement Agreement would apply to CytoSorb, VetResQ, and BetaSorb products.

The 18-year term of this license agreement expired in August of 2024, and no further payments were made.

For the year ended December 31, 2025, per the terms of the license agreement, we did not record royalty costs associated with this license agreement.

Product Payment & Reimbursement

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“ZE2025-09” as this code is being updated annually).

A dedicated coding as well as reimbursement for hemoadsorption was effective

since January 1, 2017 (procedure code “8-821.2 adsorption of hydrophobic, small and middle-sized molecular substances”).

A dedicated coding as well as reimbursement for hemoadsorption was effective since January 1, 2017 (procedure code “8-821.2 adsorption of hydrophobic, small and middle-sized molecular substances”).

According to the hospital’s budget negotiations, the reimbursement rate not only covers the cost of the device, but the procedural costs as well.

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In 2021, SwissDRG performed the first cost analysis of all procedures coded with 99.76.31.

This analysis showed that there were no additional treatment costs associated with use of CytoSorb against the relevant DRGs, suggesting CytoSorb may be cost neutral or even cost-saving across all indications.

This analysis showed that there was no additional treatment costs associated with use of CytoSorb against the relevant DRGs, suggesting CytoSorb may be cost neutral or even cost-saving across all indications.

Europe (excluding Germany and Switzerland)

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those recommended in relevant treatment guidelines.

The Company is currently conducting randomized controlled trials (RCTs) to achieve this in all major indications.

The Company is currently conducting randomized controlled trials (RCTs) to achieve this in some major indications.

In the meantime, we are leveraging health economics, local data generation and KOL management in all major territories, with our partners and local sales teams, such as France, England, Italy, Spain, Russia, Belgium, Netherlands, Luxembourg, Poland, Sweden, Norway, Denmark and Finland.

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Other Markets

CytoSorb is currently marketed and distributed in more than 76 countries around the world including Russia, Turkey and Israel.

CytoSorb is currently marketed and distributed in more than 70 countries around the world.

It is generally paid for through the standard DRG (diagnosis related group) payment, dedicated reimbursement codes, tender orders, private insurance, and/or self-pay.

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CytoSorb is not yet approved in the U.S.

but has received FDA Emergency Use Authorization in April 2020 for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.

but received FDA Emergency Use Authorization (“EUA”) in April 2020 for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.

Although EUA remains in effect in the United States, the Company last sold a CytoSorb device under the EUA in 2024.

There is currently no specific reimbursement for CytoSorb in the U.S.

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If CytoSorb can improve outcomes and reduce the costs of ICU treatment and hospital length of stay, it could potentially save hospitals a significant amount of money.

In January 2021, the Centers for the Centers for Medicare & Medicaid Services (CMS) announced the Medicare Coverage of Innovative Technology (MCIT) pathway that will provide national Medicare coverage as early as the same day as FDA market authorization for Breakthrough Designated medical devices, where coverage would last 4 years.

Although this program was rescinded by CMS in November 2021, a legislative version of the program is currently contained within the CARES 2.0 bill, though not yet approved.

In June 2023, CMS announced a new initiative called “Transitional Coverage for Emerging Technologies” (TCET) as a potential replacement for MCIT, that would provide guaranteed coverage to FDA Breakthrough Devices for a certain period of time.

In June 2023, CMS announced a new initiative called “Transitional Coverage for Emerging Technologies” (TCET) that would provide guaranteed coverage to FDA Breakthrough Devices for a certain period of time.

In August 2024, CMS published a final notice detailing the TCET pathway.

Eligibility requires a) FDA Breakthrough Device Designation, b) Determination that the device falls within a Medicare benefit category c) It is not also covered by a CMS National Coverage

Determination (NCD), and d) that no other law or regulation excludes participation.

Eligibility requires a) FDA Breakthrough Device Designation, b) Determination that the device falls within a Medicare benefit category c) It is not also covered by a CMS National Coverage Determination (NCD), and d) that no other law or regulation excludes participation.

Manufacturers can voluntarily submit a formal self-nomination to be evaluated for the TCET program within 12 months of anticipated FDA marketing authorization.

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CMS anticipates that approved devices will have coverage under a TCET NCD for approximately 5 or more years as evidence is generated to address identified evidence gaps that can lead to a predictable, long-term Medicare coverage determination.

CytoSorbents plans to pursue CMS TCET coverage given that it believes that DrugSorb-ATR, which was granted FDA Breakthrough Device Designation for the removal of ticagrelor (April 2020) and Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban (August 2021) during emergent or urgent cardiothoracic surgery, meets these criteria.

CytoSorbents plans to pursue CMS TCET coverage given that it believes that DrugSorb-ATR, which was granted FDA Breakthrough Device Designation for the removal of ticagrelor

(April 2020) and Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban (August 2021) during emergent or urgent cardiothoracic surgery, meets these criteria.

Our core adsorbent porous polymer bead technology is used in our marketed products, such as the CytoSorb, ECOS-300CY, and VetResQ cartridges, and other products under advanced development, such as CytoSorb XL and DrugSorb-ATR.

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Of the four blood purification modalities, hemoperfusion is the easiest to implement.

CytoSorb is a hemoperfusion cartridge, using an adsorbent of specified pore size, which controls the size of the molecules which can diffuse into the adsorbent and vastly increases the area available for surface adsorption.

CytoSorb is a hemoperfusion cartridge, using an adsorbent of specified pore range, which controls the size of the molecules which can diffuse into the adsorbent and vastly increases the area available for surface adsorption.

As whole blood flows over our polymer adsorbent, middle molecules such as cytokines diffuse into the polymer adsorbent and are adsorbed and removed from blood.

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Accordingly, we believe that our technology has significant advantages as compared to other blood purification products, including ease of use.

We believe we are the leader in acute care blood purification for most of our various clinical applications, which is highlighted by the significantly greater number of peer-reviewed publications than any of our competitors.

We believe we are the leader in acute care blood purification for many of our various clinical applications, which is highlighted by the significantly greater number of peer-reviewed publications than any of our competitors.

Examples of E.U.

approved blood purification competitors that claim to reduce cytokines include Oxiris and SepteX (Baxter/Vantiv), PMMA (Toray), HA330 and HA380 (Jafron), TPE (multiple manufacturers), Efferon-CT and Efferon-LPS (Efferon), and EMIC-2 (Fresenius Medical Care).

approved blood purification competitors that claim to reduce cytokines include Oxiris and SepteX (Vantive), PMMA (Toray), HA330 and HA380 (Jafron), TPE (multiple manufacturers), Efferon-CT and Efferon-LPS (Efferon), and EMIC-2 (Fresenius Medical Care).

DrugSorb-ATR:

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Besides DrugSorb-ATR, PhaseBio, a now defunct clinical-stage biopharmaceutical company, had licensed an intravenously administered monoclonal antibody fragment with high affinity for ticagrelor called bentracimab and conducted the U.S.

REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) study, a Phase 3, prospective, multi-center, open-label, single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab to treat patients who present with uncontrolled major or life-threatening bleeding

(n=8) or when used prophylactically in patients who require urgent surgery or an invasive procedure to prevent bleeding (n=142).

REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) study, a Phase 3, prospective, multi-center, open-label, single-arm, non-controlled trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab to treat patients who present with uncontrolled major or life-threatening bleeding (n=8) or when used prophylactically in patients who require urgent surgery or an invasive procedure to prevent bleeding (n=142).

Investigators reported a rapid reversal of anti-platelet activity in both subgroups.

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two with septic shock, and two with cardiogenic shock.

Of 150 patients, eight patients (5.3%) had thrombotic events, including two ischemic strokes, one transient ischemic attack, three myocardial infarctions, and two with arterial thromboembolisms in the right lower extremity.

Of 150 patients, eight patients

(5.3%) had thrombotic events, including two ischemic strokes, one transient ischemic attack, three myocardial infarctions, and two with arterial thromboembolisms in the right lower extremity.

In November 2021, based on FDA feedback, PhaseBio announced that it continued to enroll more patients into the uncontrolled major or life-threatening bleeding arm of the study and intended to submit a BLA for both subgroups by Summer 2022.

However, in October 2022, PhaseBio filed for Chapter 11 bankruptcy.

The bentracimab asset was transferred to PhaseBio’s creditor, SFJ Pharmaceuticals in December 2022, who filed an FDA Biologics License Application (BLA) for bentracimab in mid-2024 based on a second interim analysis of the REVERSE-IT trial, presumably including more patients with major and life-threatening bleeding related to ticagrelor, and announced that it expected a target action date in Q1 2025.

The requested indications for use are not publicly available.

The bentracimab asset was transferred to PhaseBio’s creditor, SFJ Pharmaceuticals in December 2022, who filed an FDA Biologics License Application (BLA) for bentracimab in mid-2024 based on a second interim analysis of the REVERSE-IT trial, SFJ and SERB Pharma presented Final Phase 3 results of the prospective, single arm, non-controlled REVERSE-IT involving a total of 141 patients undergoing surgery and 71 patients with life-threatening bleeding related to ticagrelor in March 2025 at the American College of Cardiology 2025 Scientific Session.

Key outcomes indicated Bentracimab restored platelet function in the majority of participants but 18% of surgical patients and 12% of bleeding patients experienced serious adverse events with a thromboembolic event rate of 4%.

Bentracimab has received FDA Breakthrough Therapy designation and, in 2025, Orphan Drug designation for this indication.

SERB Pharmaceuticals has acquired exclusive U.S.

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We believe DrugSorb-ATR has significant advantages, particularly safety, cost, and ease of use, over Bentracimab in cardiac surgery.

In December 2025, AstraZeneca voluntarily withdrew Andexxa from the US market, the only marketed biologic reversal agent for direct oral anticoagulants (DOACs) such as rivaroxaban and apixaban, after the FDA stated that the serious risks of the product, including a high rate of serious or fatal thromboembolic events, led them to conclude that the risks of the product outweigh its benefits and did not issue a full approval.

A competitor’s decision to voluntarily withdraw its product from FDA consideration may create a potential opportunity for the Company by reducing competitive pressure and increasing interest in alternative therapeutic options.

Because the Company’s products utilize a different modality, do not share the same underlying risks that led to the withdrawal, and will offer a lower cost than an expensive biologic reversal agent, it may be viewed more favorably by regulators, clinicians, and potential partners, and could provide an opportunity success upon approval from the FDA.

To our knowledge, there are no specifically approved therapies for cytokine removal other than ECOS-300CY for ex vivo organ perfusion.

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Army Medical Research Acquisition Activity (“USAMRAA”), the NHLBI, and the USAF/AFMC.

The HemoDefend-BGA blood purification technology platform is designed to reduce anti-A and anti-B antibodies in plasma and whole blood.

The goal is to either enable the production of freeze dried or frozen “universal plasma” that can administered to anyone, regardless of blood type, or enable fresh warm whole blood transfusions.

The HemoDefend-BGA blood purification technology platform is designed to reduce anti-A and anti-B antibodies in plasma, platelets, and whole blood.

The goal is to enable the production of freeze dried or frozen “universal plasma” that can administered to anyone, regardless of blood type, enable the administration of off-type platelets, or enable fresh warm whole blood transfusions, respectively.

If this technology is successfully developed and approved, it could have a number of important benefits, including:

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In July 2020, the Company was awarded a three-year contract by the Assistant Secretary of Defense for Health Affairs, endorsed by the CDMRP, as part of a Peer Reviewed Medical Research Program Technology/ Therapeutic Development Award to complete preclinical development of the HemoDefend™-BGA plasma and whole blood adsorber (award number W81XWH2010712).

This award provides for maximum funding of approximately $4,422,000 over a three-year period.

As of December 31, 2024, we received approximately $4,422,000 funding under this contract and no further funding remaining under this contract.

This award provides for maximum funding of approximately $4.4 million over a three-year period.

As of December 31, 2025, we received approximately $4.4 million in funding under this contract and no further funding remaining under this contract.

On April 19, 2021, the Company received notification that it received a U.S.

Army Medical Research Acquisition Activity Award (the “USAMRAAA”) entitled “Investigation of a potassium adsorber for the treatment of hyperkalemia induced by traumatic injury and acute kidney injury in austere medicine.” The USAMRAAA Phase II Sequential Award, for up to $1,499,987, was granted to the Company to continue development of two novel and distinct treatment options for life-threatening hyperkalemia.

to the Company to continue development of two novel and distinct treatment options for life-threatening hyperkalemia.

This award is being funded by the USAMRAAA under Contract No.

W81XWH21C0045.

As of December 31, 2024, we received $1,499,987 funding under the contract and no further funding remaining under the contract.

Care Research Program (CCCRP) Battlefield Resuscitation for the Immediate Stabilization of Combat Casualties Award, for up to $1,977,024, was granted to the Company to validate the safety and efficacy of the BGA device in a preclinical study in pigs.

As of December 31, 2025, we received $1.4 million funding under the contract and no further funding remains under the contract.

On May 9, 2022, the Company received a USAMRAA Award (“USAMRAAA”) entitled “Demonstration of the Safety and Efficacy of Field-Ready Blood Group Antibody (BGA) Adsorber in the Porcine Universal Transfusion Model.” The Department of Defense (DoD) Defense Medical Research and Development Program (DMRDP) Joint Program Committee 6 (JPC-6) Combat Casualty Care Research Program (CCCRP) Battlefield Resuscitation for the Immediate Stabilization of Combat Casualties Award, for up to $1.9 million, was granted to the Company to validate the safety and efficacy of the BGA device in a preclinical study in pigs.

This award is being funded by the USAMRAAA under Contract No.

W81XWH-22-1-0235.

As of December 31, 2024, we received $1,174,000 funding under the contract and have approximately $803,000 remaining under the contract, which is expected to be completed in 2025.

On August 22, 2022, the Company received a USAMRAAA entitled “Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use.” This three-year Phase III contract, which is valued at $4,292,641, is to be used to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma.

As of December 31, 2025, we received $1.8 million funding under the contract and have approximately $0.1 million remaining under the contract, which is expected to be completed in 2026.

On August 22, 2022, the Company received a USAMRAAA entitled “Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use.” This three-year Phase III contract, which is valued at $4.3 million, is to be used to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma.

Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.

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W81XWH-22-C0046.

As of December 31, 2024, we have received $2,922,000 funding under the contract and have approximately $1,371,000 remaining under the contract, which is expected to be completed in 2025.

As of December 31, 2025, we have received $4.2 million funding under the contract and have approximately $0.1 million remaining under the contract, which is expected to be completed in 2026.

These grants represent a substantial research cost savings to us, and we believe demonstrate the strong interest of the medical and scientific communities in our technology.

We are also exploring potential eligibility in several other government-sponsored grant programs which could, if approved, represent a future source of non-dilutive funds for our research programs.

New Jersey Technology Business Tax Certificate Program

We may be eligible, from time to time, to receive cash from the sale of our Net Operating Losses and R&D tax credits under the State of New Jersey Technology Business Tax Certificate Program.

As of December 31, 2025, we have accrued a receivable of $0.4 million from the approved sale of our 2024 and 2023 state NOL and research and development credits, respectively.

We expect to collect this receivable in the first half of 2026.

As of December 31, 2024, we accrued a receivable of $1.7 million from the approved sale of our 2023 state NOL and research and development credits.

We collected this amount in April 2025.

The medical devices that we manufacture are subject to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies.

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In the EU, as in other geographies, there are limits to the claims we are allowed to make, associated with the use of our devices.

Specifically, claims that are made are required to be in applicable CE Certificate and based on our Clinical Evaluation Report, which is

part of the conformity assessment process conducted by the Notified Body.

Specifically, claims that are made are required to be in applicable CE Certificate and based on our Clinical Evaluation Report, which is part of the conformity assessment process conducted by the Notified Body.

If our claims exceed the assessed claims, either regarding performance or intended uses, we may be subject to regulatory actions, which could include customer notifications or even product recalls.

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Each of these regulatory pathways is designed to balance patient safety with innovation, ensuring that medical devices entering the market are both effective and appropriately regulated based on their level of risk.

We seek FDA clearance of DrugSorb-ATR to reduce the severity of perioperative bleeding in patients on the blood thinning drug ticagrelor that require CABG surgery under the De Novo classification, which we believe is supported by the favorable benefit to risk profile established by the pivotal STAR-T trial data and STAR Registry data for this application.

On September 27, 2024, the Company submitted a De Novo medical device application to the FDA requesting marketing approval of DrugSorb-ATR to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing CABG surgery, which was accepted for substantive review in October 2024.

Because DrugSorb-ATR has already received FDA Breakthrough Device Designation for this application, it is eligible for priority review.

We are currently in the interactive review process with FDA and expect a regulatory decision in 2025.

We remain actively engaged with the FDA seeking clearance of DrugSorb-ATR to reduce the severity of perioperative bleeding in patients on the blood thinning drug ticagrelor that require CABG surgery under the De Novo classification, which we believe is supported by the favorable benefit to risk profile established by the pivotal STAR-T trial data and STAR Registry data for this application.

With FDA clearance or approval, both before and after a device for the U.S.

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In addition, the FDA and other U.S.

regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services, the Department of Justice (DOJ), and various state Attorneys General) monitor the manner in which we promote and advertise our products.

regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services, the Department of Justice (DOJ),

and various state Attorneys General) monitor the manner in which we promote and advertise our products.

Although physicians are permitted to use their medical judgment to employ medical devices for indications other than those cleared or approved by the FDA, we are prohibited from promoting products for such “off-label” uses and can only market our products for cleared or approved uses.

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If approved, the manufacturer receives a Medical Device License (MDL), allowing commercial distribution in Canada.

Post-market surveillance, including mandatory incident reporting and compliance with MDSAP ensures continued safety and effectiveness.

CytoSorbents received MDSAP certification and then submitted its MDLA for DrugSorb-ATR to Health Canada on November 1, 2024.

We are currently in the review process with Health Canada and expect a regulatory decision in 2025.

Post-market surveillance, including mandatory incident reporting and compliance with MDSAP ensures continued safety and

effectiveness.

CytoSorbents received MDSAP certification and then submitted its initial MDLA for DrugSorb-ATR to Health Canada on November 1, 2024.

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.

Other Regulatory Matters:

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Per the FDA, “The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.

Under Section 564 of the Federal Food, Drug, and Cosmetic Act (the “Act”), the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be

used in an emergency to diagnose, treat, or prevent serious or life-threatening disease or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”

Under Section 564 of the Federal Food, Drug, and Cosmetic Act (the “Act”), the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening disease or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”

EUA is an authorization limited in scope and subject to FDA discretion regarding EUA duration.

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In 2021, we expanded direct sales to include all applications in Sweden, Denmark and Norway.

As part of this effort, the Company established CytoSorbents Poland Sp.

As part of this effort, the

Company established CytoSorbents Poland Sp.

In March 2022, the Company formed CytoSorbents Medical UK Limited to provide marketing and direct sales services in the United Kingdom and the Republic of Ireland.

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We cannot generally predict the timing of these registrations, and there can be no guarantee that we will ultimately achieve registration in countries where we have established distribution.

Outside of the EU, CytoSorb has distribution in Turkey, India, Sri Lanka, Australia, New Zealand, Russia, Serbia, Vietnam, Malaysia, Hong Kong, Chile, Panama, Costa Rica, Colombia, Brazil, Mexico, Argentina, Perú, Peru, Guatemala, Ecuador, Bolivia, the Dominican Republic, El Salvador, Iceland, Israel, UAE, Iran, Saudi Arabia and other Middle Eastern countries, and South Korea.

Outside of the EU, CytoSorb has distribution in Turkey, India, Sri Lanka, Australia, New Zealand, Russia, Serbia, Vietnam, Malaysia, Hong Kong, Taiwan, Chile, Panama, Costa Rica, Colombia, Brazil, Mexico, Argentina, Perú, Guatemala, Ecuador, Bolivia, the Dominican Republic, El Salvador, Iceland, Israel, UAE, Iran, Saudi Arabia and other Middle Eastern countries, and South Korea.

We cannot guarantee that we will generate meaningful sales in the countries where we have established registration, due to other factors such as market adoption, reimbursement and/or geopolitical developments.

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A significant portion of our revenues are from product sales in Germany.

Substantially all of our grant receipts are from government agencies in the United States.

During the years ended December 31, 2024 and 2023, one distributor accounted for 11% and 10%, respectively, of the Company’s total revenue.

All of our grant receipts are from government agencies in the United States.

During the year ended December 31, 2025 no distributor accounted for more than 10% of the Company’s total revenue.

During the year ended December 31, 2024, one distributor accounted for 11% of the Company’s total revenue.

Orders received for product from both direct customers and distributors are fulfilled upon receipt.

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Description/Indications

Size-Selective Hemoperfusion Polymeric Adsorbents

Compositions and Methods Useful in Selectively Modifying the Internal and External Surfaces of Porous Polymer Beads

Connector Assembly and Methods of Use

Crosslinked Polysaccharide Based Absorbents for Removal of Anti-A and/or Anti-B Antibodies From Human Plasma and Whole Blood

Hemocompatibility Modifiers For Cross-Linked Polymeric Material

Method of Treating Inflammation

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Method of Treating Inflammation

Polymer Modification

Method of Removal of Impurities from Whole Blood

Use of Polymeric Sorbent Polymers

Hemocompatible Modifiers

Methods of Reducing Contamination in a Biological Substance

Removing Protein Based Toxins and Potassium from Biological Fluids

Method of Treating Acute Radiation Syndrome

Use of Gastrointestinally Administered Porous Sorbent Polymers

Hemocompatible Porous Beads

Removal of Endotoxemia

Method of Removing Toxins From Blood

Connector Assembly and Methods of Use

Method of Treating Traumatic Brain Injury

Absorbents for Removal of Antibodies from Human Plasma and Whole Blood

Methods for Reducing Contamination in a Biological Substance

Methods for Removal of Toxins from Blood

Methods of Using Polymers

Multi-Functional Hemocompatible Porous Polymer Bead Sorbent for Removing Protein Based Toxins and Potassium from Biological Fluids

Multi-Functional Hemocompatible Porous Polymer Bead Sorbent For Removing Protein Based Toxins and Potassium from Biological Fluids

Polymeric Sorbent for Removal of Impurities from Whole Blood and Blood Products

The Use of a Hemocompatible Porous Polymer Bead Sorbent for Removal of Endotoxemia-Inducing Molecules

Use of A Hemocompatible Porous Polymer Bead Sorbent For Removal of Endotoxemia-Inducing Molecules

Use of Gastrointestinally Administered Porous Enteron Sorbent Polymers to Prevent or Treat Radiation Induced Mucositis, Esophagitis, Enteritis, Colitis, and Gastrointestinal Acute Radiation Syndrome

Size-Selective Polymer System

There can be no assurance that pending patent applications will result in issued patents, that patents issued to us will not be challenged or circumvented by competitors, or that such patents will be found to be valid or sufficiently broad to protect our technology or to provide us with a competitive advantage.

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We believe that there are no compliance issues associated with applicable environmental laws and regulations that would have a material adverse effect on us or our business.

We incur waste removal costs in connection with both our solid and liquid wastes which

are byproducts of our manufacturing process.

We incur waste removal costs in connection with both our solid and liquid wastes which are byproducts of our manufacturing process.

We utilize the services of various qualified contractors to dispose of these waste products.

These waste removal costs amounted to approximately $322,000 for the year ended December 31, 2024.

These waste removal costs amounted to approximately $0.3 million for the year ended December 31, 2025.

As of the issuance date of this Annual Report on Form 10-K, we had 129 employees.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business