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What changed in Cytosorbents Corp's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Cytosorbents Corp's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+388 added−337 removedSource: 10-K (2026-03-30) vs 10-K (2025-03-31)

Top changes in Cytosorbents Corp's 2025 10-K

388 paragraphs added · 337 removed · 221 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

93 edited+40 added−19 removed159 unchanged
Biggest changeThe following table provides a brief description of our patents that have been issued in the U.S.: ​ Product Patent Patent Patent Group ​ Description/Indications ​ Term ​ Expiration ​ Type ​ CytoSorb ​ Size-Selective Hemoperfusion Polymeric Adsorbents ​ 20 Years ​ 11/20/2026 ​ Standard ​ CytoSorb ​ Size-Selective Hemoperfusion Polymeric Adsorbents ​ 20 Years ​ 11/20/2026 ​ Standard ​ CytoSorb ​ Size-Selective Hemoperfusion Polymeric Adsorbents ​ 20 Years ​ 11/20/2026 ​ Standard ​ CytoSorb ​ Method of Treating Inflammation ​ 20 Years ​ 3/31/2031 ​ Standard ​ CytoSorb ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 ​ Standard ​ CytoSorb ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 ​ Standard ​ CytoSorb ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 ​ Standard ​ CytoSorb ​ Method of Treating Inflammation ​ 20 Years ​ 4/30/2031 ​ Standard ​ CytoSorb ​ Polymer Modification ​ 20 Years ​ 12/31/2031 ​ Standard ​ CytoSorb ​ Method of Removal of Impurities from Whole Blood ​ 20 Years ​ 1/6/2032 ​ Standard ​ CytoSorb ​ Use of Polymeric Sorbent Polymers ​ 20 Years ​ 8/10/2032 ​ Standard ​ CytoSorb ​ Hemocompatible Modifiers ​ 20 Years ​ 3/31/2034 ​ Standard ​ CytoSorb ​ Methods of Reducing Contamination in a Biological Substance ​ 20 Years ​ 6/3/2034 ​ Standard ​ CytoSorb ​ Removing Protein Based Toxins and Potassium from Biological Fluids ​ 20 Years ​ 10/22/2035 ​ Standard ​ CytoSorb ​ Method of Treating Acute Radiation Syndrome ​ 20 Years ​ 10/22/2035 ​ Standard ​ CytoSorb ​ Use of Gastrointestinally Administered Porous Sorbent Polymers ​ 20 Years ​ 10/22/2035 ​ Standard ​ CytoSorb ​ Hemocompatible Porous Beads ​ 20 Years ​ 10/21/2036 ​ Standard ​ CytoSorb ​ Removal of Endotoxemia ​ 20 Years ​ 5/17/2037 ​ Standard ​ CytoSorb ​ Method of Removing Toxins From Blood ​ 20 Years ​ 7/30/2038 ​ Standard ​ CytoSorb ​ Connector Assembly and Methods of Use ​ 20 Years ​ 10/16/2040 ​ Standard ​ CytoSorb ​ Method of Treating Traumatic Brain Injury ​ 20 Years ​ 9/2/2044 ​ Standard ​ CytoSorb ​ Absorbents for Removal of Antibodies from Human Plasma and Whole Blood ​ 20 Years ​ 12/6/2041 ​ Standard ​ ​ 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.
Biggest changeThe following table provides a brief description of our patents that have been issued in the U.S.: ​ Patent ​ ​ ​ ​ ​ ​ Patent ​ ​ ​ Patent No. ​ Description/Indications ​ Term ​ Expiration 9931457 ​ Compositions and Methods Useful in Selectively Modifying the Internal and External Surfaces of Porous Polymer Beads ​ 20 Years ​ 1/6/2032 11969535 ​ Connector Assembly and Methods of Use ​ 20 Years ​ 9/13/2038 12121879 ​ Crosslinked Polysaccharide Based Absorbents for Removal of Anti-A and/or Anti-B Antibodies From Human Plasma and Whole Blood ​ 20 Years ​ 12/2/2039 11020521 ​ Hemocompatibility Modifiers For Cross-Linked Polymeric Material ​ 20 Years ​ 3/31/2034 11752250 ​ Hemocompatibility Modifiers For Cross-Linked Polymeric Material ​ 20 Years ​ 3/31/2034 10946040 ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 10867001 ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 10034894 ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 11058715 ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 9717755 ​ Method of Treating Inflammation ​ 20 Years ​ 4/1/2031 12076474 ​ Method of Treating Traumatic Brain Injury ​ 20 Years ​ 5/21/2038 11602585 ​ Methods for Reducing Contamination in a Biological Substance ​ 20 Years ​ 6/28/2033 11202855 ​ Methods for Removal of Toxins from Blood ​ 20 Years ​ 3/22/2038 12280196 ​ Methods of Using Polymers ​ 20 Years ​ 6/28/2033 11723916 ​ Multi-Functional Hemocompatible Porous Polymer Bead Sorbent for Removing Protein Based Toxins and Potassium from Biological Fluids ​ 20 Years ​ 10/21/2036 11040061 ​ Multi-Functional Hemocompatible Porous Polymer Bead Sorbent for Removing Protein Based Toxins and Potassium from Biological Fluids ​ 20 Years ​ 10/21/2036 12208116 ​ Multi-Functional Hemocompatible Porous Polymer Bead Sorbent For Removing Protein Based Toxins and Potassium from Biological Fluids ​ 20 Years ​ 10/21/2036 10064406 ​ Polymeric Sorbent for Removal of Impurities from Whole Blood and Blood Products ​ 20 Years ​ 1/5/2032 10426158 ​ Polymeric Sorbent for Removal of Impurities from Whole Blood and Blood Products ​ 20 Years ​ 8/10/2032 11065600 ​ The Use of a Hemocompatible Porous Polymer Bead Sorbent for Removal of Endotoxemia-Inducing Molecules ​ 20 Years ​ 5/18/2037 11826724 ​ Use of A Hemocompatible Porous Polymer Bead Sorbent For Removal of Endotoxemia-Inducing Molecules ​ 20 Years ​ 5/18/2037 10314859 ​ Use of Gastrointestinally Administered Porous Enteron Sorbent Polymers to Prevent or Treat Radiation Induced Mucositis, Esophagitis, Enteritis, Colitis, and Gastrointestinal Acute Radiation Syndrome ​ 20 Years ​ 10/2/2035 9931357 ​ Use of Gastrointestinally Administered Porous Enteron Sorbent Polymers to Prevent or Treat Radiation Induced Mucositis, Esophagitis, Enteritis, Colitis, and Gastrointestinal Acute Radiation Syndrome ​ 20 Years ​ 10/2/2035 8211310 ​ Size-Selective Polymer System ​ 20 Years ​ 11/20/2026 ​ ​ 17 Table of Contents 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.
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.
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.
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.
CytoSorb is also approved to reduce bilirubin (e.g. in liver failure) and myoglobin (e.g. 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 approved to reduce bilirubin (e.g. in liver failure) and myoglobin (e.g. in trauma and critical illness). 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.
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.
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 removal on its critical care platforms worldwide with the exception of the U.S., in a comprehensive marketing campaign.
For detailed information regarding these partnerships, see the section entitled “Commercial and Research Partners” in item 1 of this report. 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.
For detailed information regarding these partnerships, see the section entitled “Commercial and Research Partners” in item 1 of this report. A significant portion of our revenues are from product sales in Germany. All of our grant receipts are from government agencies in the United States.
Of the four blood purification modalities, hemoperfusion is the easiest to implement. CytoSorb : 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.
Of the four blood purification modalities, hemoperfusion is the easiest to implement. CytoSorb : 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.
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.
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.
As of the issuance date of this Annual Report on Form 10-K, our patent portfolio includes 22 issued United States patents as well as multiple issued foreign patents and pending patent applications both in the U.S. and internationally, directed to various compositions and methods of use related to our blood purification technologies, which are expected to expire between 2026 and 2044 absent any patent term extensions.
As of the issuance date of this Annual Report on Form 10-K, our patent portfolio includes 24 issued United States patents as well as multiple issued foreign patents and pending patent applications both in the U.S. and internationally, directed to various compositions and methods of use related to our blood purification technologies, which are expected to expire between 2026 and 2044 absent any patent term extensions.
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.
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.
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 can lead to improved clinical outcomes.
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. ​ Competition General 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.
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 9 Table of Contents (April 2020) and Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban (August 2021) during emergent or urgent cardiothoracic surgery, meets these criteria. ​ Competition General 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.
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. Europe (excluding Germany and Switzerland) Payment for our CytoSorb device in patients with life-threatening illnesses is country dependent in Europe.
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) Payment for our CytoSorb device in patients with life-threatening illnesses is country dependent in Europe.
We are not including the information contained at http://www.cytosorbents.com , or at any other website address, as part of, or incorporating it by reference into, this Annual Report on Form 10-K. ​ 1 Table of Contents Our Products and Applications ​ CytoSorbents’ technology platform centers on hemocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood by pore capture and concentration-dependent adsorption, without the need for ligands, antibodies, cells or biologics.
We are not including the information contained at http://www.cytosorbents.com , or at any other website address, as part of, or incorporating it by reference into, this Annual Report on Form 10-K. ​ Our Products and Applications ​ CytoSorbents’ technology platform centers on hemocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood by pore capture and concentration-dependent adsorption, without the need for ligands, antibodies, cells or biologics.
Employees As of the issuance date of this Annual Report on Form 10-K, we had 149 employees. We also utilize consultants and temporary service providers who are not our employees, as necessary. None of our employees are represented by a labor union or are subject to collective-bargaining agreements and we believe we have good relationships with our employees. ​
Employees As of the issuance date of this Annual Report on Form 10-K, we had 129 employees. We also utilize consultants and temporary service providers who are not our employees, as necessary. None of our employees are represented by a labor union or are subject to collective-bargaining agreements and we believe we have good relationships with our employees. ​
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.
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 many of our various clinical applications, which is highlighted by the significantly greater number of peer-reviewed publications than any of our competitors.
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.
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.
Accordingly, the outcomes of individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other forums, both domestic and international. 15 Table of Contents We rely on a combination of patents, trademarks, trade secrets and non-disclosure agreements to protect our intellectual property.
Accordingly, the outcomes of individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other forums, both domestic and international. 16 Table of Contents We rely on a combination of patents, trademarks, trade secrets and non-disclosure agreements to protect our intellectual property.
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.
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.
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 13 Table of Contents 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.
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.
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 3 Table of Contents 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.
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.
Most European markets issue reimbursement for standard therapies only, i.e. those recommended in relevant treatment guidelines. The Company is currently conducting randomized controlled trials (RCTs) to achieve this in all major indications.
Most European markets issue reimbursement for standard therapies only, i.e. those recommended in relevant treatment guidelines. The Company is currently conducting randomized controlled trials (RCTs) to achieve this in some major indications.
The 6 Table of Contents 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. B.
The CytoSorb ® 7 Table of Contents 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. B.
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.
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 5 Table of Contents 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.
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.
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.
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. Army ($100K Phase I SBIR; $50K Phase I option, $803K Phase II SBIR, $443K Phase II enhancement), the U.S.
Since 2012, we have been awarded an aggregate of approximately $44.0 million in grants, contracts, and other non-dilutive funding from DARPA ($3.8M over 5 years), the U.S. Army ($100K Phase I SBIR; $50K Phase I option, $803K Phase II SBIR, $443K Phase II enhancement), the U.S.
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.
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.
Payment for our CytoSorb device in the U.S. for this application falls under the DRG prospective repayment system, which is currently the predominant inpatient hospital reimbursement methodology in the U.S., that was increased for COVID-19 applications as part of the CARES Act.
There is currently no specific reimbursement for CytoSorb in the U.S. Payment for our CytoSorb device in the U.S. for this application falls under the DRG prospective repayment system, which is currently the predominant inpatient hospital reimbursement methodology in the U.S., that was increased for COVID-19 applications as part of the CARES Act.
Conduct giving rise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by our conduct. 12 Table of Contents The placement of our devices in the U.S. market would be subject to regulation by the U.S.
Conduct giving rise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by our conduct. The placement of our devices in the U.S. market would be subject to regulation by the U.S.
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.
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), 13 Table of Contents and various state Attorneys General) monitor the manner in which we promote and advertise our products.
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.
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.
Terumo Cardiovascular Group On January 1, 2024, we entered into a second amended and restated agreement to the original distribution agreement from October 2016.
Terumo Cardiovascular Group On January 1, 2024, we entered into a second amended and restated agreement to an original distribution agreement from October 2016.
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).
Examples of E.U. 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).
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 9 Table of Contents (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).
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 10 Table of Contents 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.
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.
Specifically, claims that are made are required to be in applicable CE Certificate and based on our Clinical Evaluation Report, which is 11 Table of Contents 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.
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. CytoSorbents is currently seeking U.S.
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 1 Table of Contents for emergency and critical care in animals is commercialized primarily in the U.S. CytoSorbents is currently seeking U.S.
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.
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 more than 70 countries worldwide, with more than 300,000 devices used cumulatively to date.
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 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.
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 10 Table of Contents (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.
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 8 Table of Contents 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.
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 August 2024, CMS published a final notice detailing the TCET pathway.
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.
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.
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.
Due to delays in the full implementation of this Marketing Agreement, no royalties were paid under this agreement in 2024 or 2023. Aferetica s.r.l.
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.
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 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.
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 2 Table of Contents 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.
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 patients, they would be able to undergo their critical CABG surgery without significant delay and have reduced bleeding risk.
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. For patients, they would be able to undergo their critical CABG surgery without significant delay and have reduced bleeding risk.
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.
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.
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.
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.
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.
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 $1.4 million, was granted 11 Table of Contents to the Company to continue development of two novel and distinct treatment options for life-threatening hyperkalemia.
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.
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. On April 19, 2021, the Company received notification that it received a U.S.
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.
The MIB highlights the safety and efficacy of CytoSorb in this indication, as well its innovative nature and the substantial cost savings CytoSorb generates and has aided adoption in the UK. Other Markets CytoSorb is currently marketed and distributed in more than 76 countries around the world including Russia, Turkey and Israel.
The MIB highlights the safety and efficacy of CytoSorb in this indication, as well its innovative nature and the substantial cost savings CytoSorb generates and has aided adoption in the UK. Other Markets CytoSorb is currently marketed and distributed in more than 70 countries around the world.
For the year ended December 31, 2024 we have recorded royalty costs of approximately $1,060,000. License Agreement In 2003, Purolite filed a lawsuit against us asserting, among other things, co-ownership and co-inventorship of certain of our patents.
For the year ended December 31, 2025, we recorded royalty costs of approximately $1.1 million. License Agreement In 2003, Purolite filed a lawsuit against us asserting, among other things, co-ownership and co-inventorship of certain of our patents.
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. 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.
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.
From the beginning of the controlled market release in the fourth quarter of 2011 through December 31, 2024, we achieved cumulative sales of CytoSorb of approximately $248.2 million. During this time period, the CytoSorb device represented substantially all of our product sales.
From the beginning of the controlled market release in the fourth quarter of 2011 through December 31, 2025, we achieved cumulative sales of CytoSorb of approximately $285.3 million. During this time period, the CytoSorb device represented substantially all of our product sales.
Air Force program ($75K), New Jersey Technology Business Tax Certificate Program for research related 5 Table of Contents expenses ($8.6M), 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.
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.
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.
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 Scientific Advisory Board (SAB) members according to fair market value and reimburse them for their travel expenses when attending meetings in person.
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 We have been engaged in research and development since inception.
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 use in patients undergoing CABG surgery on ticagrelor. 6 Table of Contents Research and Development We have been engaged in research and development since inception.
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.
This award is being funded by the USAMRAAA under Contract No. W81XWH-22-1-0235. 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.
We incur waste removal costs in connection with both our solid and liquid wastes which 16 Table of Contents 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.
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 $0.3 million for the year ended December 31, 2025.
During the years ended December 31, 2024 and 2023, one distributor accounted for 11% and 10%, respectively, of the Company’s total revenue. Orders received for product from both direct customers and distributors are fulfilled upon receipt.
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.
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.
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. 3 Table of Contents 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.
In November 2022, all rights, title and interest to the Royalty was assigned to ROKK, LLC. In August 2024, the Company and ROKK entered into the Amended and Restated Agreement to, among other items, clarify the scope of the term “gross revenue” from which the three percent royalty payment is calculated.
In August 2024, the Company and ROKK entered into the Amended and Restated Agreement to, among other items, clarify the scope of the term “gross revenue” from which the three percent royalty payment is calculated.
On March 5, 2019, the Company announced the expansion of direct sales of CytoSorb for all applications to Poland and the Netherlands, and critical care applications to Sweden, Denmark and Norway. 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. z.o.o.
On March 5, 2019, the Company announced the expansion of direct sales of CytoSorb for all applications to Poland and the Netherlands, and critical care applications to Sweden, Denmark and Norway. In 2021, we expanded direct sales to include all applications in Sweden, Denmark and Norway.
VetResQ: Because VetResQ uses the equivalent polymer technology to CytoSorb, it benefits from the extensive human clinical experience in critical care, including diseases that also affect animals such as sepsis and infection, drug intoxication, pancreatitis, ARDS, and many other illnesses.
VetResQ: Because VetResQ uses the equivalent polymer technology to CytoSorb, it benefits from the extensive human clinical experience in critical care, including diseases that also affect animals such as sepsis and infection, drug intoxication, pancreatitis, ARDS, and many other illnesses. Aimalojic competes with VetResQ in the U.S. animal health market primarily in the indication of drug overdose.
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.
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.
Variability in the timing of registration affects the initiation of active commercialization in these countries, which affects the timing of expected CytoSorb sales. 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.
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.
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.
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 paused, pending a protocol amendment, due to slow enrollment.
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.
This award is being funded by the USAMRAAA under Contract No. W81XWH21C0045. As of December 31, 2025, we received $1.4 million funding under the contract and no further funding remains under the contract.
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 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 includes study sites in Spain, Germany, Portugal, Poland, Austria, and Italy.
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. In October 2022, the Company formed CytoSorbents France SAS to provide marketing and direct sales services in France.
As part of this effort, the 15 Table of Contents Company established CytoSorbents Poland Sp. z.o.o. 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. In October 2022, the Company formed CytoSorbents France SAS to provide marketing and direct sales services in France.
In March 2023, the EU Parliament and Council extended the MDR transition period for CytoSorbents’ CytoSorb device (Class IIb) to December 2028 and it will stay CE Marked under MDD until the end of transition period (subject to Notified Body surveillance) or until the full transition to MDR certification before the end of the transition period.
In March 2023, the EU Parliament and Council extended the MDR transition period for CytoSorbents’ CytoSorb device (Class IIb) to December 2028 and it will stay CE Marked under MDD until the end of transition period (subject to Notified Body surveillance) or until the full transition to MDR certification before the end of the transition period. 12 Table of Contents In March 2011, we successfully completed our technical file review with our notified body and received approval to apply the CE Mark to the CytoSorb device for multiple indications for use.
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 14 Table of Contents effectiveness. CytoSorbents received MDSAP certification and then submitted its initial MDLA for DrugSorb-ATR to Health Canada on November 1, 2024.
United States 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. There is currently no specific reimbursement for CytoSorb in the U.S.
United States CytoSorb is not yet approved in the U.S. 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.
Aimalojic competes with VetResQ in the U.S. animal health market primarily in the indication of drug overdose. ​ Government Research Grants We have historically been successful in obtaining technology development contracts from governmental agencies such as the National Institutes of Health and the U.S. Department of Defense, including the Defense Advanced Research Projects Agency (“DARPA”), the U.S. Army, U.S.
Government Research Grants We have historically been successful in obtaining technology development contracts from governmental agencies such as the National Institutes of Health and the U.S. Department of Defense, including the Defense Advanced Research Projects Agency (“DARPA”), the U.S. Army, U.S. Special Operations Command (“USSOCOM”), the U.S. Air Force, Air Force Material Command (“USAF/AFMC”) and others.
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. Regulation The medical devices that we manufacture are subject to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies.
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.
The 18-year term of this license agreement expired in August of 2024, and no further payments were made. ​ Product Payment & Reimbursement CytoSorb Germany Effective January 1, 2024, the coding (“OPS”) for plasmapheresis, adsorption (previously: immunoadsorption) and related treatments has been extensively restructured to enable a more precise and rational classification.
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 CytoSorb Germany Effective January 1, 2024, the coding (“OPS”) for plasmapheresis, adsorption (previously: immunoadsorption) and related treatments has been extensively restructured to enable a more precise and rational classification.
Switzerland Since 2020, the most specific procedure code (“CHOP”) for any treatment with CytoSorb has been installed: “99.76.31 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. 8 Table of Contents Switzerland Since 2020, the most specific procedure code (“CHOP”) for any treatment with CytoSorb has been installed: “99.76.31 Adsorption of hydrophobic, small and middle-sized molecular substances”.
We are approved to sell CytoSorb in all 27 countries in the EU, including Germany, Italy, France and Spain as well as the United Kingdom, and currently have either direct sales or distributors or strategic partnerships in more than 76 countries worldwide. 14 Table of Contents Registration of CytoSorb is typically required in each of these countries prior to active commercialization, in a process that can take several months to more than a year to achieve.
We are approved to sell CytoSorb in all 27 countries in the EU, including Germany, Italy, France and Spain as well as the United Kingdom, and currently have either direct sales or distributors or strategic partnerships in more than 70 countries worldwide.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe degree of market acceptance will depend upon a number of factors, including: ● the receipt of regulatory clearance of marketing claims for the uses that we are developing; ● the establishment and demonstration of the advantages, safety and efficacy of our polymer technology; ● pricing and reimbursement policies of government and third-party payers such as insurance companies, health maintenance organizations and other health plan administrators; ● the development by our competitors of products or product candidates that are similar or identical to ours; ● our ability to attract corporate partners, including medical device companies, to assist in commercializing our products; and ● our ability to effectively market our products. ​ Physicians, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our products.
Biggest changeThere is no guarantee that we will be able to achieve additional regulatory approvals, and even if we do, our products may not achieve market acceptance in the countries covered by such approvals. ​ The degree of market acceptance of our products will depend on several factors, including our ability to obtain regulatory clearance for marketing claims related to the uses we are developing; demonstrate and achieve acceptance of the safety, efficacy, and advantages of our polymer technology, as reflected in product adoption, sales, reimbursement, and inclusion in treatment guidelines;secure favorable pricing and reimbursement from government and third-party payers;compete effectively against similar or competing products; attract corporate partners to support commercialization; and successfully market our products.
The ability of the FDA to review and approve new drugs and medical devices can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.
The ability of the FDA to review and approve new drugs and medical devices can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.
Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
The regulatory pathways available to us may impact the level and type of data necessary to support our applications, and the post-marketing requirements to which we and our products will be subject. 23 Table of Contents Inadequate funding for the FDA, the SEC and other government agencies, or the downsizing thereof in connection with proposals to reduce or eliminate budgetary deficits, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, affect whether government agencies award, promptly pay or continue to fund amounts awarded under grants from such agencies, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The regulatory pathways available to us may impact the level and type of data necessary to support our applications, and the post-marketing requirements to which we and our products will be subject. 25 Table of Contents Inadequate funding for the FDA, the SEC and other government agencies, or the downsizing thereof in connection with proposals to reduce or eliminate budgetary deficits, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, affect whether government agencies award, promptly pay or continue to fund amounts awarded under grants from such agencies, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Approval of our CytoSorb device as a cytokine adsorber as well as the data we have gathered in our clinical studies to support device usage in this indication may not be sufficient for market acceptance in the medical community. We may also need to conduct additional clinical studies to gather additional data for marketing purposes.
For example, the approval of our CytoSorb device as a cytokine adsorber as well as the data we have gathered in our clinical studies to support device usage in this indication may not be sufficient for market acceptance in the medical community. We may also need to conduct additional clinical studies to gather additional data for marketing purposes.
See “Risk Factors ― “ Our business could be harmed by adverse economic conditions in Germany, our primary geographical market, or by economic and/or political instability in Germany, the EU or elsewhere caused by various factors. ” We are continuously working to obtain or improve upon the type and amount of reimbursement available to us in countries where CytoSorb is available, and as we attempt to move from an existing reimbursement platform to a new reimbursement platform, we may experience interruptions and/or reductions in the amount available for reimbursement.
See “Risk Factors ― “ Our business could be harmed by adverse economic conditions in Germany, our primary geographical market, or by economic and/or political instability in Germany, the EU or elsewhere caused by various factors. ” We are continuously working to 21 Table of Contents obtain or improve upon the type and amount of reimbursement available to us in countries where CytoSorb is available, and as we attempt to move from an existing reimbursement platform to a new reimbursement platform, we may experience interruptions and/or reductions in the amount available for reimbursement.
On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 Million in aggregate gross proceeds.
On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 million in aggregate gross proceeds ($1.4 million net of fees).
As discussed above, our management has concluded that we did not maintain effective internal control over financial reporting as of December 31, 2024, due to a material weakness relating to the accounting for stock-based compensation corresponding to grants of restricted stock units.
As discussed above, our management has concluded that we did not maintain effective internal control over financial reporting as of December 31, 2025, due to a material weakness relating to the accounting for stock-based compensation corresponding to grants of restricted stock units.
We depend upon key personnel who may terminate their employment with us at any time. As of the issuance date of this Annual Report on Form 10-K, we had 149 full-time and part-time employees as well as several consultants and temporary employees.
We depend upon key personnel who may terminate their employment with us at any time. As of the issuance date of this Annual Report on Form 10-K, we had 129 full-time and part-time employees as well as several consultants and temporary employees.
On April 12, 2020, CytoSorbents Corporation entered into an executive employment agreement with Dr. Efthymios Deliargyris, who began employment as Chief Medical Officer on May 1, 2020, with an initial term that expires on December 31, 2021. On August 14, 2024, CytoSorbents Corporation entered into an executive employment agreement with Peter J.
On April 12, 2020, CytoSorbents Corporation entered into an executive employment agreement with Dr. Efthymios Deliargyris, who began employment as Chief Medical Officer on May 1, 2020, with an initial term that expired on December 31, 2021. On August 14, 2024, CytoSorbents Corporation entered into an executive employment agreement with Peter J.
Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues. Our future financial performance will depend, at least in part, upon the introduction and customer acceptance of our products.
Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues. Our future financial performance will depend, at least in part, upon the introduction, and customer and healthcare community acceptance of our products.
There can be no assurance that we will be successful in developing and expanding commercial operations or balancing our research and development activities with our commercialization activities . We have historically been engaged primarily in research and development activities and have generated limited revenues to date.
There can be no assurance that we will be successful in continuing and expanding commercial operations or balancing our research and development activities with our commercialization activities . We have historically been engaged primarily in research and development activities and have generated limited revenues to date.
Failure to comply with the FCPA, other anti-bribery laws or other laws governing the conduct of business with foreign government entities, including local laws, could disrupt our business and lead to severe criminal and civil penalties, including imprisonment, criminal and civil fines, loss of our export licenses, suspension of our ability to do business with the federal government, denial of government reimbursement for our products and/or exclusion from participation in government healthcare programs.
Failure to comply with the FCPA, other anti-bribery laws or other laws governing the conduct of business with foreign government entities, including local laws, could disrupt our business and lead to severe criminal and civil penalties, including imprisonment, criminal and civil fines, loss of our export licenses, suspension of our ability to do business with the federal government, denial of government reimbursement for our products and/or 29 Table of Contents exclusion from participation in government healthcare programs.
Moreover, pre-clinical and clinical data are susceptible to varying interpretations, which could delay, limit or prevent additional regulatory approvals in markets not covered by the CE Mark. A number of companies in the medical device and pharmaceutical industries have suffered significant setbacks in advanced clinical studies, even after promising results in earlier studies.
Moreover, pre-clinical and clinical data are susceptible to varying interpretations, which could delay, limit or prevent additional regulatory approvals in markets not covered by the CE Mark. A number of companies in the 26 Table of Contents medical device and pharmaceutical industries have suffered significant setbacks in advanced clinical studies, even after promising results in earlier studies.
We have limited manufacturing experience and capabilities, we may not be able to manufacture sufficient quantities at an acceptable cost or quality, or without shut-downs or delays. In March 2011, we received approval from our notified body to apply the CE Mark to our CytoSorb device for commercial sale as a cytokine adsorber.
Although we have significant manufacturing experience and capabilities, we may not be able to manufacture sufficient quantities at an acceptable cost or quality, or without shut-downs or delays. In March 2011, we received approval from our notified body to apply the CE Mark to our CytoSorb device for commercial sale as a cytokine adsorber.
Specifically, our controls were not effectively designed or operating to ensure that restricted stock unit expense was properly accounted for. We are actively engaged in remediating the identified material weakness.
Specifically, our controls were not effectively designed or operating to ensure that non-cash restricted stock unit expense was properly accounted for. We are actively engaged in remediating the identified material weakness.
Although the law includes limited exceptions, including for certain information collected as part of clinical trials as specified in the law, it may regulate or impact our processing of 29 Table of Contents personal information depending on the context. It remains unclear what, if any, modifications will be made to this legislation or how it will be interpreted.
Although the law includes limited exceptions, including for certain information collected as part of clinical trials as specified in the law, it may regulate or impact our processing of personal information depending on the context. It remains unclear what, if any, modifications will be made to this legislation or how it will be interpreted.
Mariani, who began employment as Chief Financial Officer on August 14, 2024 following the retirement of former CFO Kathy Bloch, with an initial term that expires on December 31, 2025.
Mariani, who began employment as Chief Financial Officer on August 14, 2024 following the retirement of former CFO Kathy Bloch, with an initial term that expired on December 31, 2025.
These conditions are expected to persist into 2025 and may lead to higher labor costs. If we fail to attract and retain qualified personnel, or if we experience labor shortages, we may experience higher costs and other difficulties.
These conditions are expected to persist into 2026 and may lead to higher labor costs. If we fail to attract and retain qualified personnel, or if we experience labor shortages, we may experience higher costs and other difficulties.
Item 1A. Risk Factors Risks Related to our Business and our Industry We have a history of losses and expect to incur substantial future losses. We have experienced substantial operating losses since inception.
Item 1A. Risk Factors Risks Related to our Business and our Industry We have a history of losses and may incur future losses. We have experienced substantial operating losses since inception.
Management has begun implementing measures to strengthen our internal control over financial reporting, including redesigning internal control procedures and enhancing documentation processes related to the accounting for restricted stock unit grant and vesting events. These efforts are intended 31 Table of Contents to ensure accurate and timely reporting in accordance with U.S. GAAP for both interim and annual periods.
Management has begun implementing measures to strengthen our internal control over financial reporting, including redesigning internal control procedures and enhancing documentation processes related to the accounting for restricted stock unit grant and vesting events. These efforts are intended to ensure accurate and timely reporting in accordance with U.S. GAAP for both interim and annual periods.
After the expiration of the initial terms, the employment agreements automatically renew for additional terms of one year unless either party provides written notice of non-renewal at least 60 days prior to a renewal. The employment agreements for the Named Executive Officers above have automatically renewed for another one-year term.
After the expiration of the initial terms, the employment agreements automatically renew for additional terms of one year unless either party provides written notice of non-renewal at least 60 days prior to a renewal. The employment agreements for the Named Executive Officers above have automatically renewed for subsequent one-year terms.
Any change in export or import laws and regulations, shift in the enforcement or scope of existing laws, tariffs, and regulations, or change in the countries, governments, persons, products, or technologies targeted by such laws, tariffs, and regulations, could also result in decreased use of our products, or in our decreased ability to export or sell our 28 Table of Contents products to existing or potential customers.
Any change in export or import laws and regulations, shift in the enforcement or scope of existing laws, tariffs, and regulations, or change in the countries, governments, persons, products, or technologies targeted by such laws, tariffs, and regulations, could also result in decreased use of our products, or in our decreased ability to export or sell our products to existing or potential customers.
No assurance can be given that our product development efforts will be successful, that our current CE Mark will enable us to achieve profitability, that additional regulatory approvals in other countries will be obtained, that any of our products will be manufactured at a competitive cost and will be of acceptable quality, that reimbursement will be available or satisfactory, that we will be able to achieve profitability or that profitability, if achieved, can be sustained, or our ability to raise additional capital when needed or on terms acceptable to us.
No assurance can be given that our product development and commercial efforts will be successful, that additional regulatory approvals in other countries will be obtained, that any of our products will be manufactured at a competitive cost and will be of acceptable quality, that reimbursement will be available or satisfactory, that we will be able to achieve profitability or that profitability, if achieved, can be sustained, or our ability to raise additional capital when needed or on terms acceptable to us.
As of the issuance date of this Annual Report on Form 10-K, we have raised a total of $7.3 million, net of offering fees, through the Rights Offering, and the exercise of the Series A Right Warrants. The equity raises also provided for $5 million of restricted cash to become unrestricted.
As of the issuance date of this Annual Report on Form 10-K, we have raised a total of $6.8 million, net of offering fees, through the Rights Offering, and the exercise of the Series A Right Warrants. The equity raises also provided for $5 million of restricted cash to become unrestricted.
As we seek to determine commercially viable indications for our product candidates, we may consider pursuing a variety of indications that may be approved through one of several different FDA regulatory clearance or approval pathways, and under the jurisdiction of different FDA review divisions within the FDA’s Office of Device Evaluation.
As we seek to determine commercially viable indications for our product candidates, we may consider pursuing a variety of indications that may be approved through one of several different FDA regulatory clearance or approval pathways, and under the jurisdiction of different FDA review divisions within the FDA.
Accordingly, we must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and 25 Table of Contents quality control. We have limited experience in establishing, supervising and conducting commercial manufacturing.
Accordingly, we must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. We have limited experience in establishing, supervising and conducting commercial manufacturing.
Our pending and future patent applications may not result in patents being issued, and even if issued, the patents may not meaningfully protect our products or product candidates, effectively prevent competitors and third parties 21 Table of Contents from commercializing competitive products or otherwise provide us with any competitive advantage.
Our pending and future patent applications may not result in patents being issued, and even if issued, the patents may not meaningfully protect our products or product candidates, effectively prevent competitors and third parties from commercializing competitive products or otherwise provide us with any competitive advantage.
See “A pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations.” As a result, seasonality has had, and we expect it to continue to have, an impact on our results of operations. Although historically we have been a research and development company, we are in the process of commercializing our products.
See “A pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations.” As a result, seasonality has had, and we expect it to continue to have, an impact on our results of operations. Although historically we have been a research and development company, we are currently commercializing some of our products.
We have identified a material weakness in our internal control over financial reporting, which could, if not effectively remediated, result in additional restatements of our financial statements, and a failure to meet our reporting and financial obligations, each of which could adversely affect our results of operations and financial condition.
In our previous Form 10K, we identified a material weakness in our internal control over financial reporting, which could, if not effectively remediated, result in additional restatements of our financial statements, and a failure to meet our reporting and financial obligations, each of which could adversely affect our results of operations and financial condition.
While clinical studies conducted by us and others 24 Table of Contents have produced results we believe to be encouraging, data already obtained, or in the future obtained, from pre-clinical studies and clinical studies do not necessarily predict the results that will be obtained from later pre-clinical studies and clinical studies.
While clinical studies conducted by us and others have produced results we believe to be encouraging, data already obtained, or in the future obtained, from pre-clinical studies and clinical studies do not necessarily predict the results that will be obtained from later pre-clinical studies and clinical studies.
Management and other 20 Table of Contents employees may voluntarily terminate their employment with us at any time. Additionally, the increasing demand for qualified personnel may make it more difficult for us to attract and retain qualified employees.
Management and other employees may voluntarily terminate their employment with us at any time. Additionally, the increasing demand for qualified personnel may make it more difficult for us to attract and retain qualified employees.
Ensuring we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort. ​
Ensuring we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort. ​ 32 Table of Contents
For the year ended December 31, 2024, our cash burn, which we define as the total of cash used in operating and investing activities from our statement of cash flows, was approximately $15.1 million. Our current and historical cash burn is not necessarily indicative of our future use of cash and cash equivalents.
For the year ended December 31, 2025, our cash burn, which we define as the total of cash used in operating and investing activities from our statement of cash flows, was approximately $12.8 million. Our current and historical cash burn is not necessarily indicative of our future use of cash and cash equivalents.
As of December 31, 2024, we had an accumulated deficit of approximately $304.0M, which included net losses of approximately $20.7M and $29.2M for the years ended December 31, 2024 and 2023, respectively. Our losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies and general and administrative expenses.
As of December 31, 2025, we had an accumulated deficit of approximately $312.2M, which included net losses of approximately $8.2M and $20.7M for the years ended December 31, 2025 and 2024, respectively. Our losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies and general and administrative expenses.
Without patent protection for our products and product candidates, we may be open to competition from generic versions of such methods and devices. 22 Table of Contents We have commenced the process of seeking regulatory approvals of our products and product candidates, but the approval process involves lengthy and costly clinical studies and is, in large part, not in our control.
Without patent protection for our products and product candidates, we may be open to competition from generic versions of such methods and devices. 24 Table of Contents We have received and continue to seek additional regulatory approvals of our products and product candidates, but the approval process involves lengthy and costly clinical studies and is, in large part, not in our control.
Many of these entities have significantly greater research and development capabilities and budgets than we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for us.
Many of these entities have significantly greater research and development capabilities and budgets than we do, as well as substantially more marketing, manufacturing, financial and managerial resources.
Compliance with changing corporate governance and public disclosure regulations may result in additional expense. Keeping abreast of, and in compliance with, changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations will require an increased amount of management attention and external resources.
Additionally, keeping abreast of, and in compliance with, changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, will require an increased amount of management attention and external resources.
Even though we have received CE mark certification of the CytoSorb device, there can be no assurance that we will be able to continue to comply with the required annual auditing requirements or other international regulatory requirements that may be applicable.
Current international regulations classify our CytoSorb device as a Class IIb device. Even though we have received CE mark certification of the CytoSorb device, there can be no assurance that we will be able to continue to comply with the required annual auditing requirements or other international regulatory requirements that may be applicable.
On January 10, 2025, we closed the subscription period of its previously announced shareholder Rights Offering (the “Rights Offering”), raising aggregate gross proceeds of $6.25 million from the sale of all 6.25 million Units reserved for the Rights Offering.
On January 10, 2025, the Company closed the subscription period of its previously announced rights offering (the “Rights Offering”), raising aggregate gross proceeds of $6.25 million ($5.4 million, net of fees) from the sale of all 6.25 million Units reserved for the Rights Offering.
For example, over the last several years, including from December 22, 2018 until January 25, 2019, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
Such events may have a material adverse effect on the Company’s business, operating results, financial condition and prospects. A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations. A pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect our business and operations.
These events may result in shareholder dilution and a decline in our share price, which could have a material adverse effect on the Company’s business, operating results, financial condition and prospects. A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations.
From time to time, we may experience temporary or long-term disruptions in the supply of certain of our raw materials that could have a material adverse effect on our business, financial condition and results of operations. Due to our limited marketing, sales and distribution experience, we may be unsuccessful in our efforts to sell our products.
From time to time, we may experience temporary or long-term disruptions in the supply of certain of our raw materials that could have a material adverse effect on our business, financial condition and results of operations.
Furthermore, if: ● we are not able to obtain re-certification for CytoSorb’s current use; ● we are not able to do so in time before the existing certificate expires; ● CytoSorb does not meet the new (and more stringent) requirements under the Medical Devices Regulation; or ● any variation in the uses for which the CE Mark has been affixed CytoSorb requires us to perform further research or to modify the technical documentation required to affix the CE Mark, our revenues and operating results could be adversely affected and our reputation could be harmed. ​ We may pursue various indications for our product candidates, and they may be subject to different FDA regulatory pathways for marketing authorization, and under the jurisdiction of different FDA review divisions within the FDA’s Office of Device Evaluation.
Furthermore, if we are unable to obtain re-certification for CytoSorb’s current use, fail to do so before the existing certificate expires, are unable to satisfy the more stringent requirements of the Medical Devices Regulation, or are required to conduct additional research or modify technical documentation in connection with any variation of the uses for which the CE Mark has been affixed, our revenues and operating results could be adversely affected and our reputation could be harmed: We may pursue various indications for our product candidates, and they may be subject to different FDA regulatory pathways for marketing authorization, and under the jurisdiction of different FDA review divisions within the FDA.
On December 30, 2021, we entered into an Open Market Sale Agreement with Jefferies LLC (the “Sale Agreement”). Pursuant to the Sale Agreement we may offer to sell, from time to time, shares of our common stock, up to a maximum of $25,000,000.
On December 30, 2021, we entered into an Open Market Sale Agreement with Jefferies LLC (the “Sale Agreement”), also referred to herein as our “ATM facility”). Pursuant to the Sale Agreement we may offer to sell, from time to time, shares of our common stock, up to a maximum of $2.5 million.
During the year ended December 31, 2024, the Company sold 382,823 shares pursuant to the Sale Agreement, at an average selling price of $1.04 per share, generating net proceeds of approximately $388,000.
During the year ended December 31, 2024, the Company sold 382,823 shares pursuant to the Sale Agreement, at an average selling price of $1.04 per share, generating net proceeds of approximately $0.3 million. During the year ended December 31, 2025, the Company did not sell any shares pursuant to the Sale Agreement.
A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.
We cannot be sure that claims will not be asserted against us. A successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.
Significant economic downturns or international trade disruptions or disputes could adversely affect our business and operating results. Significant portions of our business are conducted in Europe, including the U.K.; Asia; and other international geographies.
Economic downturns, international trade disruptions, wars, terrorism, and geopolitical conflicts could materially and adversely affect our business and operating results. Significant portions of our business are conducted in Europe (including the U.K.), Asia, and other international markets.
Another tranche of $5 million may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application. Concurrently with the closing of the first tranche, the Company paid off our existing debt with Bridge Bank.
Under this initial facility, another tranche of $5 million would have been available at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company received FDA marketing approval of its DrugSorb-ATR application. Concurrently with the closing of the first tranche, the Company paid off our existing debt with Bridge Bank.
We expect to enter into agreements with third parties for the commercial marketing, and distribution of our products. There can be no assurance that parties we may engage to market and distribute our products will: ● satisfy their financial or contractual obligations to us; ● adequately market our products; or ● not offer, design, manufacture or promote competing products.
We expect to enter into additional agreements with third parties for the commercial marketing, and distribution of our products. There can be no assurance that any third parties we may engage to market and distribute our products will satisfy their financial or contractual obligations to us, effectively promote our products, or refrain from offering, designing, manufacturing, or promoting competing products.
As of December 31, 2024, three shareholders hold 17.2% of our shares and our directors and officers hold 5.6% of our shares on a fully diluted basis.
As of December 31, 2025, three shareholders hold 16.6% of our shares and our directors and officers hold 6.3% of our shares on a fully diluted basis.
Any such compromise of our data security and access to, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage our reputation, provide our competitors with valuable information, and subject us to additional costs which could adversely affect our business.
Any compromise of our data security or unauthorized access to, or disclosure or loss of, confidential or proprietary information could disrupt our operations, harm our reputation, provide competitors with valuable information, result in additional costs, and materially and adversely affect our business.
We primarily source the raw materials for our products from domestic suppliers but may be required to source from international suppliers if our domestic suppliers are unable to meet our supply requirements.
We primarily source the raw materials for our products from domestic suppliers but may be required to source from international suppliers if our domestic suppliers are unable to meet our supply requirements. Generally, we typically second source and validate the quality of chemicals, raw materials, and molded parts.
Directors, executive officers and principal stockholders own a significant percentage of the shares of common stock, which will limit your ability to influence corporate matters. Our directors, executive officers and principal stockholders together beneficially own a significant percentage of the voting control of the common stock on a fully diluted basis.
Our directors, executive officers and principal stockholders together beneficially own a significant percentage of the voting control of the common stock on a fully diluted basis.
In this regard, we expect that there will continue to be new proposed laws, regulations and industry standards relating to privacy and data protection in the United States, the European Union and other jurisdictions, and we cannot determine the impact such future laws, regulations and standards may have on our business.
In this regard, we expect that there will continue to be new proposed laws, regulations and industry standards relating to privacy and data protection in the United States, the European Union and other jurisdictions, and we cannot determine the impact such future laws, regulations and standards may have on our business. 30 Table of Contents In the U.S., even for companies that are not “covered entities” or business associates” under HIPAA, the U.S.
We cannot predict the effect of future exchange rate fluctuations on our operating results. 26 Table of Contents If we are unable to convince physicians and other health care providers as to the benefits of our products, we may incur delays or additional expense in our attempt to establish market acceptance.
If we are unable to convince physicians and other health care providers as to the benefits of our products, we may incur delays or additional expense in our attempt to establish market acceptance.
Although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, distribution partners, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.
Although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, distribution partners, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. 23 Table of Contents The patent position of medical device companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation.
Our failure with respect to any or all of these matters would have a material adverse effect on our business, operating results, financial condition and prospects. We will require additional capital in the future to fund our operations.
Our failure with respect to any or all of these matters would have a material adverse effect on our business, operating results, financial condition and prospects. 18 Table of Contents We may require additional capital in the future to fund our operations and failure to raise additional capital or generate cash flows necessary to maintain our operations could reduce our ability to compete successfully and harm our results of operations.
The Company will require additional financing in the future to support the commercialization of its products and proposed products, to initiate and complete new additional clinical studies, and for general working capital purposes.
We would likely require additional capital to support the commercialization of our products and proposed products, to initiate and complete new additional clinical studies and for general working capital purposes.
Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock, and one Series B Right Warrant to purchase one share of common stock.
Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the 19 Table of Contents Company, one Series A Right Warrant to purchase one share of common stock with an expiration date of February 24, 2025, and one Series B Right Warrant to purchase one share of common stock with an expiration date of April 10, 2025.
In the ordinary course of our business, we generate, collect and store proprietary information, including intellectual property and business information, as well as employee personal data. The secure storage, maintenance, and transmission of and access to this information is important to our operations our day-to-day business and our reputation. Security breaches have become more common across industries.
In the ordinary course of our business, we generate, collect, and store proprietary information, including intellectual property, business information, and employee personal data, and the secure storage, transmission, and access to this information are critical to our operations and reputation.
If we were to change the supplier of a raw material for a product, the cost for the material could be greater than the amount we paid with the previous supplier.
We 27 Table of Contents do not have any significant concentration of risk with respect to any one particular supplier. If we were to change the supplier of a raw material for a product, the cost for the material could be greater than the amount we paid with the previous supplier.
In Europe, which we expect to provide the initial market for our products, the notified body and Competent Authority govern, where applicable, development, clinical studies, labeling, manufacturing, registration, notification, clearance or approval, marketing, distribution, record keeping, and reporting requirements for medical devices.
In Europe, the notified body and Competent Authority govern, where applicable, development, clinical studies, labeling, manufacturing, registration, notification, clearance or approval, marketing, distribution, record keeping, and reporting requirements for medical devices. Different regulatory requirements may apply to our products depending on how they are categorized by the notified body under these laws.
As of December 31, 2024, we had current assets of approximately $21.9 million, including cash and cash equivalents of $3.3 million and current liabilities of approximately $9.8 million.
As of December 31, 2025, we had current assets of approximately $20.6 million, including total cash and cash equivalents of $7.8 million, including restricted cash of $1.5 million and current liabilities of approximately $9.7 million.
On March 28, 2025, the closing price of our common stock, as reported on Nasdaq, was $1.00. Historically, medical device company securities such as our common stock have experienced extreme price fluctuations.
Our common stock closed as high as $1.31 and as low as $0.62 per share between January 1, 2025 and December 31, 2025 on Nasdaq. On December 31, 2025, the closing price of our common stock, as reported on Nasdaq, was $0.64. Historically, medical device company securities such as our common stock have experienced extreme price fluctuations.
Despite modest European and global growth, there are many economic and political issues that could negatively impact the health of Germany’s economy, the broader EU economy, and the world economy overall.
For the year ended December 31, 2025, we derived approximately 32% of our net product sales from sales in Germany. Despite modest European and global growth, there are many economic and political issues that could negatively impact the health of Germany’s economy, the broader EU economy, and the world economy overall.
The loss of services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays in development or approval of our products, loss of sales and diversion of management resources.
The loss of services of key personnel, or the inability to attract and retain additional qualified personnel, could result in delays in development or approval of our products, loss of sales and diversion of management resources. We may not be successful in obtaining the FDA’s or Health Canada’s authorization and successful commercialization for DrugSorb-ATR in the U.S. or Canada, respectively.
Some of the factors leading to this volatility include, but are not limited to: ● fluctuations in our operating results; ● announcements of product releases by us or our competitors; ● announcements of clinical data, analyst or media reports; ● financial status: ● announcements of acquisitions and/or partnerships by us and our competitors; and ● general market conditions. ​ There is no assurance that the price of our common stock will not continue to be volatile.
Some of the factors contributing to this volatility include fluctuations in our operating results; regulatory developments; announcements of product releases, clinical data, acquisitions, or partnerships by us or our competitors; analyst or media reports; changes in our financial condition; and general market conditions.
There can be no assurance that after the expenditure of substantial funds and efforts, we will successfully develop and commercialize any products, generate any significant revenues or ever achieve and maintain a substantial level of sales of our products. 19 Table of Contents If users of our products are unable to obtain adequate reimbursement from third-party payers, or if reimbursement is not available in specific countries, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve anticipated revenues.
If users of our products are unable to obtain adequate reimbursement from third-party payers, or if reimbursement is not available in specific countries, or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not achieve anticipated revenues.
In addition, currency devaluation can result in a loss to us if we hold deposits of that currency or if it reduces the cost-competitiveness of our products.
Fluctuations in foreign currency exchange rates could affect our revenues, operating costs and operating margins. In addition, currency devaluation can result in a loss to us if we hold deposits of that currency or if it reduces the cost-competitiveness of our products. We cannot predict the effect of future exchange rate fluctuations on our operating results.
Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of medical devices. We cannot be sure that claims will not be asserted against us.
We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued. Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of medical devices.
After giving effect to our merger into our wholly-owned Delaware subsidiary, provisions of our Certificate of Incorporation, as amended and restated, and bylaws may discourage, delay or prevent a merger or acquisition that our stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares, and may also frustrate or prevent any attempt by stockholders to change the direction or management of us.
In addition, provisions of our certificate of incorporation and bylaws, as well as Delaware law, may discourage, delay, or prevent a merger, acquisition, or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares, and may limit stockholders’ ability to influence the direction or management of the Company.
In the future, and especially as we further expand our sales efforts in international markets, our customers will increasingly make payments in non-U.S. currencies. Fluctuations in foreign currency exchange rates could affect our revenues, operating costs and operating margins.
A significant portion of our revenues is currently derived in the local currencies of the foreign jurisdictions in which our products are sold. Accordingly, we are subject to risks relating to fluctuations in currency exchange rates. In the future, and especially as we further expand our sales efforts in international markets, our customers will increasingly make payments in non-U.S. currencies.
Our business could be harmed by adverse economic conditions in Germany, our primary geographical market, or by economic and/or political instability in Germany, the EU or elsewhere caused by various factors. For the year ended December 31, 2024, we derived approximately 37% of our net product sales from sales in Germany.
These entities represent significant competition for us. 28 Table of Contents Our business could be harmed by adverse economic conditions in Germany, our primary geographical market, or by economic and/or political instability in Germany, the EU or elsewhere caused by various factors.
The Right Warrants, as discussed below, will provide additional opportunity to purchase up to an additional 6,250,000 shares of common stock. Proceeds from the Rights Offering satisfied the second condition of a debt covenant which now allows for the $5.0 million of restricted cash on our consolidated balance sheet to become unrestricted, and available for use.
Up to an additional 6,250,000 shares of common stock may have been issued upon exercise of the Rights Warrants. Proceeds from the closing of the subscription period satisfy a debt covenant which allowed for $5 million of restricted cash on the Company’s consolidated balance sheets to now become unrestricted, and available for use.
The patent position of medical device companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.
Immediately after the reverse stock split, we changed our state of incorporation from the State of Nevada to the State of Delaware pursuant to an Agreement and Plan of Merger, dated December 3, 2014, whereby we merged with and into our recently formed, wholly-owned Delaware subsidiary.
On December 3, 2014, we effected a 25:1 reverse stock split and changed our state of incorporation from Nevada to Delaware through a merger with our wholly owned Delaware subsidiary, at which time we adopted our current certificate of incorporation and bylaws.
For example, federal and state budgetary cuts at state and federal agencies, the withholding of federal grant funds, staffing shortages and the reallocation of regulatory priorities by key federal agencies that oversee our products, services, and associated reimbursement, including FDA and the U.S. Department of Health and Human Services more broadly could adversely affect our business.
Domestically, we may be adversely affected by budgetary constraints, funding cuts, staffing shortages, or shifts in regulatory priorities at agencies overseeing our products and reimbursement, including the FDA and the U.S. Department of Health and Human Services, which could delay approvals, disrupt oversight, or require significant resources to address compliance.
Currently, our certificate of incorporation, as amended and restated, which was effective June 12, 2019, authorizes the issuance of up to 100,000,000 shares of common stock, of which approximately 45,170,000 shares remain available for issuance as of December 31, 2024 and may be issued by us without stockholder approval.
Our certificate of incorporation authorizes the issuance of up to 5,000,000 shares of “blank check” preferred stock and up to 100,000,000 shares of common stock, a substantial portion of which remains available for issuance, in each case without stockholder approval.
The amount of long-term capital needed is expected to depend on many factors, including: ● rate of sales growth and adoption of the Company’s products in the marketplace; ● product gross margin; ● continued progress and cost of the Company’s research and development programs; ● progress with and cost of the Company’s pre-clinical studies and clinical studies; ● the time and costs involved in obtaining regulatory clearance in other countries and/or for other indications; ● costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims; ● costs of developing sales, marketing and distribution channels; ● market acceptance and reimbursement of the Company’s products; and cost for training physicians and other health care personnel. ​ 17 Table of Contents We have an effective shelf registration statement dated September 30, 2024 with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units.
The amount of long-term capital we require will depend on various factors, including the rate of sales growth and market adoption of our products; product gross margins; the progress and costs of our research and development, pre-clinical and clinical studies; the time and expense associated with obtaining regulatory approvals in additional countries or for new indications; costs related to protecting and enforcing our intellectual property; the development of sales, marketing, and distribution capabilities; and market acceptance, reimbursement, and training of physicians and other healthcare personnel.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeIn accordance with this policy, senior management will also communicate the occurrence of any significant cybersecurity incidents to our Board of Directors, Audit Committee and auditors on a timely basis and will keep them informed of the remediation plans and progress. ​ 32 Table of Contents
Biggest changeIn accordance with this policy, senior management will also communicate the occurrence of any significant cybersecurity incidents to our Board of Directors, Audit Committee and auditors on a timely basis and will keep them informed of the remediation plans and progress. ​ 33 Table of Contents

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe lease commenced in April 2021 and expires in March 2037. As of December 31, 2024, our monthly base rent is approximately $121,000. 2. Our office facility leases in Berlin, Germany requires combined base rent payments amounting to approximately $12,100 per month. The initial lease term of both leases ends August 31, 2026.
Biggest changeThe lease commenced in April 2021 and expires in March 2037. As of December 31, 2025, our monthly base rent is approximately $124,000. 2. Our office facility leases in Berlin, Germany requires combined base rent payments amounting to approximately $12,100 per month. The initial lease term of both leases ends August 31, 2031.
In addition, the Company is obligated to monthly operating expenses of approximately $3,000 per month. 3. Our warehouse facility lease in Berlin, Germany commenced on April 1, 2021 and requires monthly payments of base rent of approximately $7,800 through its expiration on March 31, 2026.
In addition, the Company is obligated to monthly operating expenses of approximately $3,000 per month. 3. Our warehouse facility lease in Berlin, Germany commenced on April 1, 2021 and requires monthly payments of base rent of approximately $7,800 through its expiration on March 31, 2031.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeRegardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors. On March 5, 2024, a former employee, filed a complaint against us in the Superior Court of New Jersey, Law Division, Mercer County, alleging breach of the New Jersey Conscientious Employee Protection Act (“CEPA”).
Biggest changeRegardless of outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors. On March 5, 2024, a former employee, filed a complaint against us in the Superior Court of New Jersey, Law Division, Mercer County, alleging retaliatory termination in breach of the New Jersey Conscientious Employee Protection Act (“CEPA”).
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The complaint specifically alleges that we violated the provisions of the CEPA by allegedly terminating the former employee in retaliation for complaining about certain business practices. We dispute these allegations and intend to vigorously defend against them, but there can be no assurance as to the outcome of the litigation. Item 4. Mine Safety Disclosures.
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Following further discussion, the parties agree there was a professional misunderstanding between them and have amicably resolved the litigation. Item 4. Mine Safety Disclosures. Not applicable. ​ 34 Table of Contents PART II
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Not applicable. ​ 33 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeApproximately $149.7 million of this amount was available as of December 31, 2024. We have also allocated $19.7 million of our total shelf amount to our ATM facility. As of December 31, 2024, approximately $19.4 million was available for use under the ATM facility.
Biggest changeApproximately $149.7 million of this amount was available as of December 31, 2025. We have also allocated $20.0 million of our total shelf amount to our ATM facility. As of December 31, 2025, approximately $19.4 million was available for use under the ATM facility, subject to certain limitations.
Recent Sales of Unregistered Securities We had no sales of unregistered securities in 2024 that have not been previously disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q. ​ Item 6. [Reserved] ​ ​
Recent Sales of Unregistered Securities We had no sales of unregistered securities in 2025 that have not been previously disclosed in a Current Report on Form 8-K or Quarterly Report on Form 10-Q. ​ Item 6. [Reserved] ​ ​
Issuer Purchases of Securities There were no repurchases of the Company’s securities during the year ended December 31, 2024.
Issuer Purchases of Securities There were no repurchases of the Company’s securities during the year ended December 31, 2025.
Approximate Number of Equity Security Holders As of March 31, 2025, there were approximately 11,100 stockholders of record. Because shares of our common stock are held by depositaries, brokers and other nominees, the number of beneficial holders of our shares is larger than the number of stockholders of record.
Approximate Number of Equity Security Holders As of December 31, 2025, there were approximately 9,395 stockholders of record. Because shares of our common stock are held by depositaries, brokers and other nominees, the number of beneficial holders of our shares is larger than the number of stockholders of record.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations Comparison of the year ended December 31, 2024 and 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2024 ​ 2023 ​ ​ ​ ​ As Restated ​ ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ Amount Revenue Amount Revenue Product revenue ​ $ 35,594,520 100 % $ 31,084,953 100.0 % Cost of goods sold ​ 10,468,529 29 % 9,131,716 29 % Gross profit ​ 25,125,991 71 % 21,953,237 71 % Operating expenses: ​ ​ ​ Research and development ​ 6,916,181 19 % 15,594,442 50 % Selling, general and administrative ​ 34,995,749 98 % 38,307,415 123 % Total operating expenses ​ 41,911,930 118 % 53,901,857 173 % Loss from operations ​ (16,785,939) (47) % (31,948,620) (103) % Other income (expense): ​ ​ ​ ​ Interest expense, net ​ (1,399,092) (4) % (157,891) (1) % Gain (loss) on foreign currency transactions ​ (4,224,721) (12) % 1,949,257 6 % Miscellaneous income (expense) ​ (30) 0 % 96,755 0 % Total other income (expense), net ​ (5,623,843) (16) % 1,888,121 6 % Loss before benefit from income taxes ​ $ (22,409,782) (63) % $ (30,060,499) (97) % ​ Product Revenue For the year ended December 31, 2024, we generated total revenue of approximately $35.6 million as compared to revenues of approximately $31.1 million for the year ended December 31, 2023, an increase of approximately $4.5 million, or 15%.
Biggest changeResults of Operations Comparison of the year ended December 31, 2025 and 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Year Ended December 31, ​ ​ 2025 ​ 2024 ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ ​ ​ ​ Amount ​ ​ ​ Revenue ​ ​ ​ Amount ​ ​ ​ Revenue ​ ​ (in thousands) ​ ​ ​ (in thousands) ​ ​ ​ Revenue ​ $ 37,063 100 % $ 35,595 ​ 100.0 % Cost of goods sold ​ 10,572 ​ 28.5 % 10,708 ​ 30.1 % Gross profit ​ 26,491 ​ 71.5 % 24,887 ​ 69.9 % Operating expenses: ​ ​ ​ ​ ​ ​ ​ Research and development ​ 5,085 ​ 13.7 % 7,607 ​ 21.4 % Selling, general and administrative ​ 35,645 ​ 96.2 % 33,732 ​ 94.8 % Restructuring ​ ​ 510 ​ 1.4 % ​ — ​ — % Total operating expenses ​ 41,240 ​ 111.3 % 41,339 ​ 116.1 % Loss from operations ​ (14,749) ​ (39.8) % (16,452) ​ (46.2) % Other income (expense): ​ ​ ​ ​ ​ ​ ​ Interest expense, net ​ (2,612) ​ (7.0) % (1,399) ​ (3.9) % Gain (loss) on foreign currency transactions ​ ​ 9,321 ​ 25.1 % ​ (4,225) ​ (11.9) % Loss on abandoned patents ​ ​ (559) ​ (1.5) % ​ (334) ​ (0.9) % Total other income (expense), net ​ 6,150 ​ 16.6 % (5,958) ​ (16.7) % Loss before benefit from income taxes ​ $ (8,599) ​ (23.2) % $ (22,410) ​ (63.0) % Benefit from income taxes ​ ​ 401 ​ 1.1 % ​ 1,691 ​ 4.8 % Net loss ​ $ (8,198) ​ (22.1) % ​ (20,719) ​ (58.2) % ​ 37 Table of Contents Revenue For the year ended December 31, 2025, we generated total revenue of approximately $37.1 million as compared to revenues of approximately $35.6 million for the year ended December 31, 2024, an increase of approximately $1.5 million, or 4.1%, and down 0.4% on a constant currency basis.
Due to the current competitive labor market and rising inflation, our labor costs have risen significantly in order to attract and retain qualified employees throughout our organization. In addition, we have experienced raw material price increases primarily related to the oil-based chemicals used in the polymer manufacturing process as well additional requests for higher fuel surcharges from most suppliers.
Due to the competitive labor market and rising inflation, our labor costs have risen significantly in order to attract and retain qualified employees throughout our organization. In addition, we have experienced raw material price increases primarily related to the oil-based chemicals used in the polymer manufacturing process as well as additional requests for higher fuel surcharges from most suppliers.
Critical Accounting Policies and Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
Critical Accounting Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.
For further discussion regarding the Loan Agreement please see Long Term Debt note to our Consolidated Financial Statements, included elsewhere in this Annual Report on Form 10-K.
For further discussion regarding the Loan Agreement please see Note 5, Long Term Debt, to our Consolidated Financial Statements, included elsewhere in this Annual Report on Form 10-K.
CytoSorb is not yet approved in the United States. 34 Table of Contents In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs.
CytoSorb is not yet approved in the United States. 35 Table of Contents In the U.S. and Canada, CytoSorbents is developing the DrugSorb ® ™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs.
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 more than 70 countries worldwide, with more than 270,000 devices used cumulatively to date.
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 more than 70 countries worldwide, with more than 300,000 devices used cumulatively to date.
The following discussion and analysis of the results of operations and financial condition for the fiscal years ended December 31, 2024 and 2023 should be read in conjunction with our consolidated financial statements, and the notes to those consolidated financial statements that are included elsewhere in this Report.
The following discussion and analysis of the results of operations and financial condition for the fiscal years ended December 31, 2025 and 2024 should be read in conjunction with our consolidated financial statements, and the notes to those consolidated financial statements that are included elsewhere in this Report.
This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses to a third party. Liquidity and Capital Resources Since inception, our operations have been primarily financed through the issuance of debt and equity securities.
This benefit was realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses and R&D credits to a third party. Liquidity and Capital Resources Since inception, our operations have been primarily financed through the issuance of debt and equity securities.
The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements.
The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and were additionally used for working capital purposes and to fund general business requirements.
Benefit from Income Taxes Our benefit from income taxes was approximately $1.7 million and $0.8 million for the years ended December 31, 2024, and 2023, respectively.
Benefit from Income Taxes Our benefit from income taxes was approximately $0.4 million and $1.7 million for the years ended December 31, 2025, and 2024, respectively.
The Right Warrants are transferable until they have expired. ● On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 Million in aggregate gross proceeds.
On February 24, 2025, approximately 1.4 million Series A Right Warrants were exercised by holders, including members of management and the Board of Directors, at an exercise price of $1.13 per warrant, providing an additional $1.6 million in aggregate gross proceeds ($1.4 million net of fees).
Gain (Loss) on Foreign Currency Transactions For the year ended December 31, 2024, the loss on foreign currency transactions was approximately $4.2 million, as compared to a gain on foreign currency transactions of approximately $1.9 million for the year ended December 31, 2023.
Gain (Loss) on Foreign Currency Transactions For the year ended December 31, 2025, the gain on foreign currency transactions was approximately $9.3 million, compared to a loss on foreign currency transactions of approximately $4.2 million for the year ended December 31, 2024.
The loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of December 31, 2024, as compared to December 31, 2023. The exchange rate of the Euro to the U.S. dollar was $1.03 per Euro as of December 31, 2024, as compared to $1.11 per Euro at December 31, 2023.
The exchange rate of the Euro to the U.S. dollar was $1.17 per Euro as of December 31, 2025, as compared to $1.03 per Euro at December 31, 2024. The 2024 loss is directly related to the decrease of the exchange rate of the Euro as of December 31, 2024, as compared to December 31, 2023.
Rising energy costs, including electricity and fossil fuels, have also made it more expensive to support our operations, manufacturing, and commercial activities. We have also experienced increases in our transportation costs; however, we have been able to substantially mitigate these cost increases by implementing bulk shipping methods. Inflationary pressures may continue to impact our product gross margins in the future.
Rising energy costs, including electricity and fossil fuels, have also made it more expensive to support our operations, manufacturing, and commercial activities. We have also experienced increases in our transportation costs; however, we have been able to substantially mitigate these cost increases by implementing bulk shipping methods.
Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock, and one Series B Right Warrant to purchase one share of common stock.
Participants in the Rights Offering received Units, each Unit comprising of one share of common stock of the Company, one Series A Right Warrant to purchase one share of common stock with an expiration date of February 24, 2025, and one Series B Right Warrant to purchase one share of common stock with an expiration date of April 10, 2025.
It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.
It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company continues to actively pursue regulatory approval of DrugSorb-ATR with the U.S.
This improvement was the result of revenue growth, and a 22% reduction in total operating expense. Interest Expense, Net For the year ended December 31, 2024, Interest expense, net, was approximately $1.4 million, as compared to $0.2 million for the year ended December 31, 2023.
This improvement was the result of revenue growth and gross margin improvement. Interest Expense, Net For the year ended December 31, 2025, net interest expense was approximately $2.6 million, as compared to $1.4 million for the year ended December 31, 2024.
The 2023 gain is directly related to the increase of the exchange rate of the Euro as of December 31, 2023, as compared to December 31, 2022. The exchange rate of the Euro to the U.S. dollar was $1.11 per Euro as of December 31, 2023, as compared to $1.07 per Euro as of December 31, 2022.
The exchange rate of the Euro to the U.S. dollar was $1.03 per Euro as of December 31, 2024, as compared to $1.11 per Euro as of December 31, 2023.
As of December 31, 2024, we have approximately $9.8 million in cash (a non-GAAP measure), including approximately $3.3 million in unrestricted cash and cash equivalents, $5 million in restricted cash classified as a current asset, and $1.5 million of non-current restricted cash which is not expected to fund Company’s operations beyond the next twelve months from the issuance of these consolidated financial statements This matter raise substantial doubt about the Company’s ability to continue as a going concern.
As of December 31, 2025, we have approximately $7.8 million in cash (a non-GAAP measure), including approximately $6.3 million in unrestricted cash and cash equivalents, and $1.5 million of non-current restricted cash which may not be sufficient to fund the Company’s operations beyond the next twelve months from the issuance of these consolidated financial statements.
Summary of Operational and Business Highlights ● Total product revenue (excluding grant income) was $35.6 million for the year ended December 31, 2024, an increase of $4.5 million, or 15%, compared to the year ended December 31, 2023 ● Gross profit was 25.1 million for the year ended December 31, 2024, an increase of $3.2 million, or 14%, compared to the year ended December 31, 2023 ● Our loss from operations was improved by 47% to approximately $16.8 million, from $31.9 million for the years ended December 31, 2024 and 2023 respectively.
Summary of Operational and Business Highlights ● Total product revenue was $37.1 million for the year ended December 31, 2025, an increase of 4.1%, compared to the year ended December 31, 2024 ● Gross profit for the year ended December 31, 2025 was 71.5% compared to 69.9% in the prior year, ● Our loss from operations was improved by 10.4% to approximately $14.7 million, from $16.5 million for the years ended December 31, 2025 and 2024 respectively.
Loan and Security Agreement On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group.
Loan and Security Agreement On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million (the “Avenue Capital Commitment”), to be disbursed in two tranches.
Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $5,000,000 of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use.
Proceeds from the Rights Offering on January 10, 2025 satisfied the second condition of the debt covenant which now allows for the $5.0 million of restricted cash on the Company’s consolidated balance sheets to become unrestricted, and available for use. 41 Table of Contents The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and will additionally be used for working capital purposes and to fund general business requirements.
As a result of these additional uncertainties, the accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof.
However, as of the issuance date of this Annual Report on Form 10-K, the Company continues to be in the process of an equity raise through a Rights Offering that has included the following: ● On January 10, 2025, we closed the subscription period of its previously announced shareholder Rights Offering (the “Rights Offering”), raising aggregate gross proceeds of $6.25 million from the sale of all 6.25 million Units reserved for the Rights Offering.
Rights Offering On January 10, 2025, the Company closed the subscription period of its previously announced rights offering (the “Rights Offering”), raising aggregate gross proceeds of $6.25 million ($5.4 million net of fees) from the sale of all 6.25 million Units reserved for the Rights Offering.
Research and Development Expenses Our research and development costs were approximately $6.9 million and $15.6 million for the years ended December 31, 2024 and 2023, respectively, a decrease of approximately $8.7 million, or 56%. This decrease was driven by a decrease in our clinical trial costs due to the completion of the STAR-T clinical trial in December 2023.
Gross margins were 71.5% and 69.9% for the years ended December 31, 2025 and 2024, respectively. Research and Development Expenses Our research and development costs were approximately $5.1 million and $7.6 million for the years ended December 31, 2025 and 2024, respectively, a decrease of approximately $2.5 million, or 33.2%.
Gross Profit Gross profit was approximately $25.1 million for the year ended December 31, 2024, an increase of approximately $3.2 million or 14%, as compared to gross profit of $22.0 million for the year ended December 31, 2023. Product gross margins were 71% and 71% for the years ended December 31, 2024 and 2023, respectively.
Loss on Abandoned Patents Loss on abandoned patents was approximately $0.6 million for the year ended December 31, 2025, an increase of approximately $0.2 million or 67.4%, as compared to loss on abandoned patents of $0.3 million for the year ended December 31, 2024.
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.
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.
Additional sources of liquidity available to us include issuance of additional equity securities through the Series B Right Warrant, or other public or private equity offerings, debt financings or from other sources. The sale of additional equity may result in dilution to our shareholders.
Additional sources of liquidity available to us include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale 40 Table of Contents of additional equity may result in dilution to our shareholders. There is no assurance that we will be able to secure funding on terms acceptable to us, or at all.
In addition, research and development compensation expenses decreased by $1.2 million from $3.6 million for the year ended December 31, 2023 to $2.4 million for the year ended December 31, 2024, due to reductions in headcount. 36 Table of Contents Selling, General and Administrative Expenses Our selling, general and administrative expenses were approximately $35.0 million and $38.3 million for the years ended December 31, 2024 and 2023, respectively, a decrease of approximately $3.3 million, or 9%.
Selling, General and Administrative Expenses Our selling, general and administrative expenses were approximately $35.6 million and $33.7 million for the years ended December 31, 2025 and 2024, respectively, an increase of approximately $1.9 million, or 5%.
In March of 2024, we received approximately $880,000 in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey. 37 Table of Contents We are also proactively managing our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR to U.S.
Resource Allocation and Path to Cash-Flow Profitability We proactively manage our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR to the FDA and Health Canada and the development of clinical data.
As of December 31, 2024, we had current assets of approximately $21.6 million and current liabilities of approximately $9.9 million. As of December 31, 2024, $19.7 million of our total shelf amount was allocated to our at-the-market facility (“ATM facility”), of which approximately $19.4 million remained available.
As of December 31, 2025, we had current assets of approximately $20.6 million and current liabilities of approximately $9.7 million.
Actual results could differ from those estimates. We believe the following critical accounting policies and estimates have significant effect in the preparation of our consolidated financial statements. 39 Table of Contents Revenue Recognition Revenue is recognized when the Company ships its products to its direct customers and distributors/strategic partners.
Actual results could differ from those estimates. We believe the following critical accounting estimates have significant effect in the preparation of our consolidated financial statements. Uncertain tax positions and valuation allowances: The Company records income tax expense and related liabilities based on estimates of amounts expected to be taxable or deductible in tax returns filed in various jurisdictions.
Another tranche of $5 million may be disbursed at the Company’s request between July 1, 2025 and December 31, 2025, provided that the Company receives FDA marketing approval of its DrugSorb-ATR application. Concurrently with the closing of the first tranche, the Company paid off our existing debt with Bridge Bank.
The restriction was released on a dollar-for-dollar basis for equity raised between $3.0 million and $5.0 million. The second tranche (“Tranche 2”) consisted of $5.0 million, which would have been disbursed at the Company’s request between July 1, 2025 and December 31, 2025, if the Company received FDA marketing approval of its DrugSorb-ATR application, which it did not.
As a result, our proforma unrestricted cash and cash equivalents, a non-GAAP measure, on December 31, 2024, assuming the net proceeds from the Rights Offering and the Series A Right Warrant exercise had occurred at that date, has increased by $12.3 million to $15.6 million, compared to the as reported amount of $3.3 million 38 Table of Contents Our expected future capital requirements may depend on many factors including expanding our customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the regulatory approval and introduction of DrugSorb-ATR in the U.S. and Canada which is expected in 2025, and the related opportunity to receive Tranche 2 of Avenue Capital Commitment by December 31, 2025 and extend the principle re-payment terms of the facility beginning in the third quarter of 2026.
Our expected future capital requirements may depend on many factors, including expanding our customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the U.S. which would allow for the opportunity to receive Tranche 2b of the Amended Credit Facility, and receive an additional 6-month extension of the interest-only period on the credit facility.
There is no assurance that we will be able to secure funding on terms acceptable to us, or at all. The increasing need for capital could also make it more difficult to obtain funding through either equity or debt.
Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential increased need for capital could also make it more difficult to obtain funding through either equity or debt.
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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.
Added
This improvement was primarily the result of revenue growth and gross margin improvement. ● In the first quarter, we strengthened our balance sheet with the completion of a shareholder Rights Offering in January 2025 that provided $5.4 million net proceeds, and then added another $1.4 million net proceeds with the exercise of the Series A Right Warrant in February 2025. ● In April 2025, we further supplemented our cash balance with the receipt of $1.7 million from the sale of our 2023 and amended 2022 Net Operating Loss (NOL) and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA). ● We continued to see real world validation of improved clinical outcomes (reduced serious perioperative bleeding) in cardiac surgery patients on a blood thinner from data presented at several global cardiac surgery conferences including EuroPCR, ESCVS, EACTS, and TCT. ● On July 31, 2025 the Company highlighted data demonstrating the vital and evolving role of CytoSorb therapy in the treatment of sepsis and septic shock–among the deadliest challenges in critical care medicine.
Removed
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.
Added
Recent data demonstrate early and intensive use of CytoSorb therapy was associated with improved clinical outcomes for patients suffering from these conditions. The Company presented a World Sepsis Day Global Webinar on September 10, 2025 in commemoration of Sepsis Awareness Month and World Sepsis Day.
Removed
This improvement was the result of revenue growth, and a 22% reduction in total operating expense. ● Secured a $20 million credit facility ● Launched the PuriFi Pump, and standalone hemoperfusion pump designed to support early treatment with CytoSorb without standard dialysis machines ● We submitted our DrugSorb-ATR DeNovo marketing application to the FDA on September 27, 2024, and announced FDA acceptance and initiation of substantive review of our application on October 22, 2024.
Added
See our Current Report on Form 8-K, filed with the SEC on August 1, 2025, for additional information. ● On September 16, 2025, the Company announced that it would file a new De Novo application for DrugSorb-ATR with the FDA.
Removed
This filing included the results of our STAR-T pivotal trial, and was supported with real world evidence from our STAR Registry ● We received Medical Device Single Audit Program (MDSAP) certification on November 1, 2024, a key regulatory milestone that certifies compliance of our quality management system with the standard regulatory requirements of Cananda, the United States, Brazil, Japan and Australia ● Submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, concurrent with MDSAP certification – a requirement for submission, with data from both the STAR-T trial and the STAR Registry ● Surpassed 270,000 CytoSorb treatments delivered cumulatively to date ● In the first quarter of 2025 we strengthened our balance sheet with the completion of a shareholder Rights Offering in January 2025 that provided $5.8 million net proceeds, and then added another $1.5 million, net proceeds with the exercise of the Series A Right Warrant in February.
Added
This decision followed an appeal meeting and decision by the FDA that upheld its previous denial of the Company’s DrugSorb-ATR De Novo application, but affirmed that there were no safety related issues with the device, and requested additional information to support the Company’s desired label indication.
Removed
This equity raise satisfied a debt covenant to release $5 million in restricted cash already on our balance sheet. As a result, this raise increased our unrestricted cash liquidity by a total of $12.3 million. 35 Table of Contents Impact of Inflation and Other Issues: The current high inflationary environment has impacted us in various ways.
Added
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.
Removed
The increase in revenues related to increases in direct sales and distributor sales of $1.7 million or 9%, and $2.7 million or 22%, respectively, during the year ended December 31, 2024, as compared to the year ended December 31, 2023.
Added
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.
Removed
Clinical expenses excluding compensation were approximately $2.8 million and $9.2 million for the years ended December 31, 2024 and 2023, respectively, a decrease of approximately $6.4 million.
Added
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 November 13, 2025, the Company amended its credit facility with Avenue Capital Group which provided access to an additional aggregate $2.5 million (“Tranche 2a”) from Avenue Capital Group in November 2025 and for the extension of the interest-only period from July 1, 2026 to December 31, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027.
Removed
This decrease was mainly due to a decrease in salaries of approximately $2.3 million related to headcount reductions, and a decrease in net legal, consulting and professional expenses of approximately $1.4 million. Loss From Operations Our loss from operations decreased by 47% to approximately $16.8 million, from $31.9 million for the years ended December 31, 2024 and 2023 respectively.
Added
The Company will have access to an additional aggregate $2.5 million (“Tranche 2b”) and also will receive a further six-month extension of the interest-only period to the July 1, 2027 maturity date upon FDA approval of DrugSorb-ATR by December 31, 2026. 36 Table of Contents ● On November 13, 2025, the Company announced it initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability.
Removed
The increase was due to interest incurred on the Avenue Capital Group debt that was closed during the second quarter of 2024. This financing increased the principal amount of our debt to $15 million from $5 million and the interest rate increased to 13.5% from 8%.
Added
This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the Strategic Workforce and Cost Reduction Plan, the Company reduced its workforce by approximately 10%, reduced and realigned operating and production expenses, and now expects that the Company will reach operating cash flow break-even in the second half of 2026.
Removed
During the year ended December 31, 2024, the Company sold 382,823 shares pursuant to the Sale Agreement, at an average selling price of $1.01 per share, generating proceeds of approximately $179,000, net of fees.
Added
The Company recorded a restructuring charge in the fourth quarter of approximately $0.5 million that included cash-based severance and other compensation related charges of approximately $0.4 million, and other non-cash charges of approximately $0.1 million related to the restructuring. ​ Impact of Inflation and Other Issues: The recent high inflationary environment impacted us in various ways.
Removed
In June of 2024, we closed on a $20 million term-loan facility with Avenue Capital Group which provided an initial tranche of $15 million at the closing of which $10 million was immediately available at closing and $5 million constitutes restricted cash subject to release to the Company prior to March 31, 2025, provided certain conditions are met.
Added
Inflationary pressures may continue to impact our product gross margins and other costs in the future.
Removed
FDA and Health Canada and the development of clinical data. We have also instituted and continue to maintain tight control over expenditures and have lowered our spending significantly over the past year.
Added
Revenue growth was led by strength in our distributor and strategic partner sales and direct sales outside of Germany, partially offset by lower revenue in our direct German market. The Company began a proactive reorganization and strategic realignment of our German commercial team and sales approach in the first quarter of 2025.
Removed
The Right Warrants, as discussed below, will provide additional opportunity to purchase up to an additional 6,250,000 shares of common stock. ● Proceeds from the Rights Offering satisfied the second condition of a debt covenant which now allows for the $5.0 million of restricted cash on our consolidated balance sheet to become unrestricted, and available for use. ● The Right Warrants are exercisable commencing on their date of issuance and the exercise price shall be equal to (i) in the case of the Series A Right Warrants, 90% of the 5-day volume weighted average price of our Common Stock over the last 5-trading days prior to the expiration date of the Series A Right Warrants on February 24, 2025, rounded down to the nearest whole cent but (x) not lower than $1.00 and (y) not higher than $2.00, and (ii) in the case of the Series B Right Warrants, 90% of the 5-day volume weighted average price of our common stock over the last 5-trading days prior to the expiration date of the Series B Right Warrants on April 10, 2025, rounded down to the nearest whole cent but (x) not lower than $2.00 and (y) not higher than $4.00. ● Exercise of the Right Warrants require additional investment separate from the purchase of the Units.
Added
We are making progress with this important initiative, and remain confident it will lead to stronger execution and improved performance. Gross Profit Gross profit was approximately $26.5 million for the year ended December 31, 2025, an increase of approximately $1.6 million or 6.4%, as compared to gross profit of $24.9 million for the year ended December 31, 2024.
Removed
We reserved 6.25 million shares of common stock for exercise of the Right Warrants, after which any remaining unexercised Right Warrants will immediately expire worthless.
Added
This decrease was driven by a decrease in our clinical trial costs due primarily to the completion of the STAR-T clinical trial, lower grant funded projects, as well as other clinical and product development program reductions.
Removed
As of the issuance date of this Annual Report on Form 10-K, we have raised a total of $7.3 million, net of offering fees, through the Rights Offering, and the exercise of the Series A Right Warrants. The equity raises also provided for $5 million of restricted cash to become unrestricted.
Added
This increase was mainly due to increases in legal, regulatory, financial and consulting costs including costs associated with our 2024 audited financial statements, as well as regulatory filings and initial costs associated with the anticipated approval and commercial launch of DrugSorb-ATR in North America, partially offset by decreases in stock-based compensation expense, and royalty expenses.
Removed
The Company is actively pursuing financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.
Added
The decrease in stock-based compensation expense was primarily related to the full vesting of certain stock options in earlier periods and the decrease in royalty expense was the result of the expiration of a 4% royalty in August of 2024.
Removed
The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for the products shipped or the services provided under their grant contracts. To achieve this core principle, the Company applies the following five steps: 1.
Added
Restructuring Expenses During the fourth quarter of 2025, we initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. Our restructuring expenses were $0.5 million for the year ended December 31, 2025.
Removed
Identify Contracts with Customers - The Company’s contracts with its direct customers are generally in the form of a purchase order. The Company has formal written contracts with each of its distributors/strategic partners that define their respective territories and minimum purchase commitments which must be met in order to maintain exclusivity in their territory.
Added
These costs primarily included cash-based severance and related workforce reduction charges of $0.4 million and other non-cash costs of $0.1 million. Loss From Operations Our loss from operations (including the impact of the $0.5 million restructuring charge) decreased by 10.4% to approximately $14.7 million, from $16.5 million for the years ended December 31, 2025 and 2024 respectively.
Removed
Distributors/strategic partner customers also submit purchase orders with each order that define the terms of shipment and transaction price. 2. Identify Performance Obligations - The performance obligations in contracts with direct customers and distributors/strategic partners are for the shipment of the CytoSorb device and related accessory parts. 3.
Added
The increase was due to interest incurred on our credit facility for the full year of 2025, which began in the third quarter of 2024. Additionally, we amended our credit facility which increased the principal balance outstanding under the credit facility by $2.5 million effective November 13, 2025.
Removed
Determine Transaction Price - The price charged is based on the Company’s price list for the CytoSorb device and related accessory parts for both direct customers and distributor/strategic partners. The Company does not permit returns for product sales.
Added
The gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of December 31, 2025, as compared to December 31, 38 Table of Contents 2024.
Removed
The Company also provides for certain rebates and discounts to direct customers for sales of its product that are earned based upon sales volume. These amounts, which are earned based on calendar year sales volume, are recorded as a reduction of sales as earned. 4.
Added
Effective Shelf Registration We have an effective shelf registration statement dated September 30, 2024 with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units. Approximately $149.7 million of this amount was available as of December 31, 2025.
Removed
Allocate Transaction Price to Performance Obligations - The transaction price for the performance obligation is based on the purchase orders received for both direct customers and on the type of contract and are outlined in each contract. 5.
Added
We have also allocated $20 million of our total shelf amount to our ATM facility. At December 31, 2025, approximately $19.4 million was available for use under the ATM facility, subject to certain limitations. For the year ended December 31, 2025, we did not raise any proceeds under the ATM facility.
Removed
Recognize Revenue as Performance Obligations are Satisfied - The Company satisfies its performance obligation to direct customers and distributors/strategic partners generally upon shipment of the products. Research and Development, Net of Grant Income All research and development costs, payments to laboratories, research consultants and costs related to clinical trials and studies are expensed when incurred.

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