Cytosorbents Corp

CTSO

Business Summary

CytoSorbents Corporation operates in the medical device industry, specializing in blood purification technologies for life-threatening conditions in intensive care units and cardiac surgery. The company's core business model revolves around its proprietary hemocompatible, highly porous polymer beads that remove toxic substances from blood through pore capture and surface adsorption. These cartridges are designed for use with standard hospital blood pumps, such as dialysis, continuous renal replacement therapy (CRRT), extracorporeal membrane oxygenation (ECMO), and heart-lung machines. The company generates revenue primarily through product sales to direct customers and distributors/strategic partners globally, with a significant portion of revenue derived from Germany. The company does not permit returns for product sales and offers certain rebates and discounts to direct customers based on sales volume. CytoSorbents operates as a single reportable segment, focusing on the development, testing, and selling of blood purification medical devices ¹.

The company's lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries, with more than 300,000 devices used cumulatively ². CytoSorb was initially launched in the EU as a cytokine adsorber and has received CE mark extensions for bilirubin and myoglobin removal, as well as for ticagrelor and rivaroxaban removal in cardiothoracic surgery. In the U.S., CytoSorb received FDA Emergency Use Authorization (EUA) in April 2020 for adult critically ill COVID-19 patients with respiratory failure to reduce pro-inflammatory cytokine levels, though it is not yet cleared or approved for commercial sale in the U.S. ³.

DrugSorb™-ATR is an investigational device in the U.S. and Canada, based on equivalent polymer technology to CytoSorb, aimed at reducing perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for ticagrelor removal (2020) and another for apixaban and rivaroxaban removal (2021) in cardiopulmonary bypass circuits during urgent cardiothoracic procedures ⁴. The initial focus for DrugSorb-ATR is on reducing perioperative bleeding in approximately 60,000 CABG patients on ticagrelor annually in the U.S. and Canada ⁵. The company believes this market could expand to over $1 billion over time with additional indications ⁶.

ECOS-300CY is approved in the EU for use in ex vivo organ perfusion systems to reduce cytokines and inflammatory mediators, aiming to preserve or improve the health of harvested solid organs for transplant ⁷. VetResQ, based on equivalent polymer technology to CytoSorb, is commercially available in the U.S. animal health market for treating drug intoxication, inflammation, and toxic injury in animals ⁸. The company also commercializes the PuriFi hemoperfusion pump, an EU Medical Device Regulation (MDR) approved advanced pump, launched in June 2024 in the EU and other select countries, designed to replace standard hospital blood pumps for blood purification therapies ⁹.

For the fiscal year ended December 31, 2025, CytoSorbents reported total product revenue of $37.063 million ¹⁰, an increase of 4.1% compared to $35.595 million in the prior year ¹¹. Gross profit for 2025 was $26.491 million ¹², up 6.4% from $24.887 million in 2024 ¹³. Gross margin improved to 71.5% in 2025 from 69.9% in 2024 ¹⁴. Loss from operations improved by 10.4% to $14.749 million in 2025, compared to $16.452 million in 2024 ¹⁵. Net loss for 2025 was $8.198 million ¹⁶, an improvement from $20.719 million in 2024 ¹⁷. Basic and diluted net loss per common share was $(0.13) in 2025, compared to $(0.38) in 2024 ¹⁸. Cash and cash equivalents totaled $6.249 million as of December 31, 2025 ¹⁹, with total current assets of $20.634 million ²⁰ and current liabilities of $9.709 million ²¹. Long-term debt, net of debt discount, was $16.667 million ²². The company's cash burn (cash used in operating and investing activities) for 2025 was approximately $12.8 million ²³.

Revenue growth was primarily driven by increased distributor and strategic partner sales and direct sales outside of Germany, partially offset by lower direct sales in Germany ²⁴. Research and development expenses decreased by $2.5 million, or 33.2%, to $5.085 million in 2025 from $7.607 million in 2024, mainly due to the completion of the STAR-T clinical trial, lower grant-funded projects, and other program reductions ²⁵. Selling, general and administrative expenses increased by $1.9 million, or 5%, to $35.645 million in 2025 from $33.732 million in 2024, attributed to higher legal, regulatory, financial, and consulting costs related to anticipated DrugSorb-ATR approval and commercial launch, partially offset by decreases in stock-based compensation and royalty expenses ²⁶. Royalty expense decreased from $1.9 million in 2024 to $1.1 million in 2025 due to the expiration of a 4% royalty in August 2024 ²⁷. The company recorded a restructuring charge of $0.5 million in 2025, including $0.4 million in cash-based severance and $0.1 million in non-cash charges, as part of a strategic workforce and cost reduction plan ²⁸. A significant gain on foreign currency transactions of $9.321 million was recorded in 2025, compared to a loss of $4.225 million in 2024, driven by the Euro's appreciation against the U.S. dollar ²⁹.

During 2025, the company completed a shareholder Rights Offering in January, providing $5.4 million in net proceeds ³⁰, and an additional $1.4 million in net proceeds from the exercise of Series A Right Warrants in February ³¹. In April 2025, $1.7 million was received from the sale of 2023 and amended 2022 Net Operating Loss (NOL) and R&D tax credits through the New Jersey Technology Business Tax Certificate Transfer Program ³². The company amended its credit facility with Avenue Capital Group in November 2025, securing an additional $2.5 million (Tranche 2a) and extending the interest-only period to December 31, 2026 ³³.

Business Outlook

CytoSorbents is actively pursuing regulatory approval for DrugSorb-ATR with the U.S. FDA and intends to pursue Health Canada approval once there is better visibility from the FDA ³⁴. Following the FDA's denial of its initial De Novo Request in April 2025, the company decided in September 2025 not to file a final appeal to the Director of the FDA's CDRH, opting instead to file a new De Novo application with additional information, including analyses of new real-world data, based on positive FDA upper management feedback for a potentially expedited path forward ³⁵. A pre-submission meeting with the FDA was conducted in late January 2026, and interactive discussions are ongoing to clarify and confirm the requirements for the new submission ³⁶. A regulatory decision is expected following a typical 150-day review process, which may be accelerated or extended ³⁷. Similarly, after Health Canada issued a Notice of Refusal in June 2025, the company withdrew its Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA ³⁸.

The company expects to rapidly commercialize DrugSorb-ATR in the U.S. and Canada upon approval, targeting an initial total addressable market of $300 million, with potential to grow to over $1 billion over time by pursuing additional indications for other blood thinners and expanding beyond cardiac surgery ³⁹. DrugSorb-ATR has received two FDA Breakthrough Device Designations, one for ticagrelor removal and another for apixaban and rivaroxaban removal ⁴⁰. The company plans to pursue additional reimbursement and coverage options through the New Technology Add on Payment (NTAP) and Transitional Coverage for Emerging Technologies (TCET) programs, believing these could enhance the value proposition, although they are not deemed necessary for sales ⁴¹.

Operationally, CytoSorbents initiated a strategic workforce and cost reduction plan in November 2025, which included a workforce reduction of approximately 10% and realignment of operating and production expenses ⁴². As a result of these measures, the company expects to reach operating cash flow break-even in the second half of 2026 ⁴³. The company continues to maintain tight control over expenditures and has lowered spending over the past year ⁴⁴.

Regarding capital allocation, the company has an effective shelf registration statement from September 30, 2024, enabling it to raise up to $150 million through various securities offerings ⁴⁵. Approximately $149.7 million of this amount was available as of December 31, 2025 ⁴⁶. Additionally, $20 million of the shelf amount is allocated to an ATM facility, with approximately $19.4 million available as of December 31, 2025 ⁴⁷. The company's Amended Loan and Security Agreement with Avenue Capital Group, entered into on November 13, 2025, provides access to an additional $2.5 million (Tranche 2b) upon FDA approval of DrugSorb-ATR by December 31, 2026, and a further six-month extension of the interest-only period to the July 1, 2027 maturity date ⁴⁸. The company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, and equity financing ⁴⁹.

The company faces structural headwinds and execution risks, particularly concerning the uncertainty of obtaining FDA and Health Canada approvals for DrugSorb-ATR, which could significantly impact its ability to generate substantial revenues in these markets ⁵⁰. The denial letters from both regulatory bodies highlight the need for additional information to support the desired label indications ⁵¹. Furthermore, the company's ability to achieve market acceptance for its products is uncertain, depending on factors such as regulatory clearance for marketing claims, demonstration of safety and efficacy, favorable pricing and reimbursement, effective competition, and successful marketing ⁵². The German Hospital Care Improvement Act, mandating hospital reform from January 2025 through 2029, could impact the company's business by de-emphasizing DRG payments and increasing focus on quality measures and complex operations ⁵³. While the company believes its products align with these reforms, the ultimate impact and timing of implementation remain uncertain ⁵⁴.

Risk Factors

CytoSorbents faces several material risks, including a history of substantial operating losses and an accumulated deficit of approximately $312.2 million as of December 31, 2025 ⁵⁵, raising substantial doubt about its ability to continue as a going concern within the next twelve months ⁵⁶. The company's cash and cash equivalents, including restricted cash, totaled approximately $7.8 million as of December 31, 2025, with $6.3 million unrestricted ⁵⁷. There is a risk of requiring additional capital in the future, and failure to raise such funds could significantly dilute existing shareholders or impose restrictive debt terms ⁵⁸. Regulatory risks are significant, particularly the uncertainty of obtaining FDA and Health Canada marketing approval for DrugSorb-ATR, as evidenced by the denial letters received in April and June 2025, respectively, and the need for additional data to support label indications ⁵⁹. The company's existing patents are scheduled to expire between 2026 and 2044 ⁶⁰, posing a risk of increased competition from generic versions if new patent protection is not secured or maintained. Economic conditions in Germany, which accounted for approximately 32% of net product sales in 2025 ⁶¹, and broader geopolitical conflicts, such as the war in Ukraine and the Middle East, could disrupt global commerce, supply chains, and demand for products, potentially affecting revenue and operating results ⁶². The company is also exposed to product liability and clinical/preclinical liability risks inherent in medical device testing, manufacturing, and marketing ⁶³. Cybersecurity threats and data breaches pose a risk to proprietary and confidential information, potentially leading to operational disruptions, reputational harm, and additional costs ⁶⁴. Non-compliance with data protection laws like GDPR and CCPA could result in significant penalties ⁶⁵. The company is not in compliance with Nasdaq's Minimum Bid Price Requirement, and its common stock could be delisted if compliance is not regained by March 31, 2026, or within an extended period ⁶⁶.

Management Priorities

Management's message to shareholders emphasizes a proactive approach to driving commercial success and achieving cash-flow profitability, despite a history of operating losses and an accumulated deficit of approximately $312.2 million as of December 31, 2025 ⁶⁷. A key strategic priority is the pursuit of regulatory approval for DrugSorb-ATR in the U.S. and Canada, with management actively engaging with the FDA to clarify requirements for a new De Novo submission following previous denials ⁶⁸. The company expects a regulatory decision within a typical 150-day review process, which may be accelerated or extended ⁶⁹. Another strategic priority is cost reduction and operational optimization, as evidenced by the Strategic Workforce and Cost Reduction Plan initiated in November 2025, which included a 10% workforce reduction and realignment of expenses ⁷⁰. Management anticipates reaching operating cash flow break-even in the second half of 2026 as a result of these efforts ⁷¹. Finally, management is focused on strengthening the balance sheet and securing additional liquidity, having completed a shareholder Rights Offering in January 2025 that provided $5.4 million in net proceeds ⁷², and securing an additional $2.5 million from Avenue Capital Group in November 2025 with a potential for another $2.5 million upon FDA approval of DrugSorb-ATR ⁷³.

View Source Annual Report on SEC.gov ↗

References

[1] Item 1, Business — Overview
[2] Item 1, Business — Overview
[3] Item 1, Business — Overview
[4] Item 1, Business — Overview
[5] Item 1, Business — Our Products and Applications
[6] Item 1, Business — Overview
[7] Item 1, Business — Our Products and Applications
[8] Item 1, Business — Our Products and Applications
[9] Item 1, Business — Our Products and Applications
[10] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[11] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[12] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[13] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[14] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[15] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[16] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[17] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[18] Item 7, MD&A — Results of Operations Comparison of the year ended December 31, 2025 and 2024
[19] Item 8, Consolidated Balance Sheets
[20] Item 8, Consolidated Balance Sheets
[21] Item 8, Consolidated Balance Sheets
[22] Item 8, Consolidated Balance Sheets
[23] Item 1A, Risk Factors — 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.
[24] Item 7, MD&A — Revenue
[25] Item 7, MD&A — Research and Development Expenses
[26] Item 7, MD&A — Selling, General and Administrative Expenses
[27] Item 8, Note 8 — Royalty Agreement
[28] Item 7, MD&A — Restructuring Expenses
[29] Item 7, MD&A — Gain (Loss) on Foreign Currency Transactions
[30] Item 7, MD&A — Summary of Operational and Business Highlights
[31] Item 7, MD&A — Summary of Operational and Business Highlights
[32] Item 7, MD&A — Summary of Operational and Business Highlights
[33] Item 7, MD&A — Summary of Operational and Business Highlights
[34] Item 1, Business — Overview
[35] Item 1, Business — Cardiac Surgery
[36] Item 1, Business — Cardiac Surgery
[37] Item 1, Business — Cardiac Surgery
[38] Item 1, Business — Cardiac Surgery
[39] Item 1, Business — Overview
[40] Item 1, Business — Overview
[41] Item 1, Business — Our Products and Applications
[42] Item 7, MD&A — Summary of Operational and Business Highlights
[43] Item 7, MD&A — Summary of Operational and Business Highlights
[44] Item 7, MD&A — Resource Allocation and Path to Cash-Flow Profitability
[45] Item 7, MD&A — Effective Shelf Registration
[46] Item 7, MD&A — Effective Shelf Registration
[47] Item 7, MD&A — Effective Shelf Registration
[48] Item 7, MD&A — Summary of Operational and Business Highlights
[49] Item 7, MD&A — Resource Allocation and Path to Cash-Flow Profitability
[50] Item 1A, Risk Factors — 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.
[51] Item 1A, Risk Factors — 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.
[52] Item 1A, Risk Factors — 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.
[53] Item 1A, 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.
[54] Item 1A, 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.
[55] Item 1A, Risk Factors — We have a history of losses and may incur future losses.
[56] Item 1A, Risk Factors — We have a history of losses and may incur future losses.
[57] Item 1A, Risk Factors — 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.
[58] Item 1A, Risk Factors — 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.
[59] Item 1A, Risk Factors — 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.
[60] Item 1, Business — Intellectual Property and Patent Litigation
[61] Item 1A, 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.
[62] Item 1A, Risk Factors — Economic downturns, international trade disruptions, wars, terrorism, and geopolitical conflicts could materially and adversely affect our business and operating results.
[63] Item 1A, Risk Factors — 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.
[64] Item 1A, Risk Factors — Cyberattacks and other security breaches could compromise our proprietary and confidential information which could harm our business and reputation.
[65] Item 1A, Risk Factors — Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
[66] Item 1A, Risk Factors — We are not in compliance with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”), and our common stock could be delisted if we do not regain compliance with listing standards within time frame required by the Nasdaq staff, which could have a material adverse effect on the liquidity of our common stock.
[67] Item 1A, Risk Factors — We have a history of losses and may incur future losses.
[68] Item 7, MD&A — Summary of Operational and Business Highlights
[69] Item 7, MD&A — Summary of Operational and Business Highlights
[70] Item 7, MD&A — Summary of Operational and Business Highlights
[71] Item 7, MD&A — Summary of Operational and Business Highlights
[72] Item 7, MD&A — Summary of Operational and Business Highlights
[73] Item 7, MD&A — Summary of Operational and Business Highlights

Analysis on 5/22/2026

Recent Material Events

2026-07-06Material Event

CytoSorbents Corporation received a notice from Nasdaq stating it is not in compliance with the minimum Market Value of Listed Securities requirement, which must be at least $35 million. The company has been granted a 180-day grace period until December 28, 2026, to regain compliance. To satisfy the requirement, the market value of the common stock must meet or exceed $35 million for at least 10 consecutive business days during this period. Management is evaluating actions to restore compliance, including potentially increasing stockholders' equity to at least $2.5 million. Failure to meet the standard by the compliance date may result in delisting. CytoSorbents Corporation is a medical technology company that develops products for extracorporeal blood purification.

View filing ↗

2026-06-25Material Event

CytoSorbents Corporation announced at the 2026 Life Sciences Forum that it has scheduled two pre-submission meetings with the FDA in August 2026 to discuss its ticagrelor and DOAC programs. CytoSorbents Corporation is a life sciences company that develops and commercializes medical devices and pharmaceutical-based products for the treatment of extracorporeal blood purification. extracorporeal blood purification industry.

View filing ↗