What the changes say
- Cytosorbents faces intense regulatory setbacks with FDA and Health Canada denials for DrugSorb-ATR.
- The company struggles with Nasdaq delisting risks due to low share prices and ongoing capital needs.
- Accumulated deficit reached $312.2 million despite narrowed annual net losses of $8.2 million.
What changed since the prior 10-K
New
- NewRisks Related to our Business and our Industry
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
As of December 31, 2025, we held $7.8 million in cash and cash equivalents against a 2025 cash burn of $12.8 million, threatening our operations if we cannot raise more capital.
- NewRisks Related to our Business and our Industry
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
We raised $6.8 million net through a Rights Offering and Series A Right Warrants, which unlocked $5 million of restricted cash.
- NewRisks Related to our Business and our Industry
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
The FDA issued a denial letter for our De Novo Request for DrugSorb-ATR on April 25, 2025, and subsequently upheld the denial after an appeal hearing.
- NewRisks Related to our Business and our Industry
discussions with the FDA on the final requirements are complete. Following the new De Novo submission, a regulatory decision would be expected following a typical 150-day review process but may be accelerated or extended depending on interactive discussions with the FDA related to submission questions
Health Canada issued a Notice of Refusal for DrugSorb-ATR on June 26, 2025, causing us to withdraw our reconsideration request pending FDA clarity.
- NewRisks Related to our Business and our Industry
Adverse economic conditions and political or regulatory developments could materially and adversely affect our business
Global economic instability, international trade laws, tariffs, and potential funding cuts at the FDA or HHS could disrupt our operations.
- NewRisks Related to our Business and our Industry
Due to our limited resources for marketing, sales and distribution, and our reliance on many different distributors, we may be unsuccessful in our efforts to successfully commercialize our products in one or more countries
Our reliance on third-party distributors for marketing and sales risks delayed product sales and increased costs if partners fail to perform.
- NewRisks Related to our Business and our Industry
Risks Connected to Our Securities
We received a notice of non-compliance from Nasdaq on October 2, 2025, because our common stock traded below the $1.00 minimum average closing price requirement.
- NewRisks Related to our Business and our Industry
Our Board of Directors’ authority to issue additional securities and anti-takeover provisions in our governing documents under Delaware law could adversely affect the rights of our common stockholders and discourage or delay a change in control
Our certificate of incorporation authorizes 100,000,000 common shares and 5,000,000 preferred shares, which can dilute stockholders and deter takeover bids.
Dropped
- DroppedRisks Related to our Business and our Industry
We will require additional capital in the future to fund our operations
- DroppedRisks Related to our Business and our Industry
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
We will require additional capital to fund operations based on December 31, 2024 financials.
- DroppedRisks Related to our Business and our Industry
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
Rights offering proceeds satisfied a debt covenant to free restricted cash.
- DroppedRisks Related to our Business and our Industry
Although historically we have been a research and development company, we are in the process of commercializing 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
Series A Right Warrants exercise provided $1.6 million in gross proceeds.
- DroppedRisks Related to our Business and our Industry
from commercializing competitive products or otherwise provide us with any competitive advantage. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative products in a non-infringing manner
- DroppedRisks Related to our Business and our Industry
Our business could be negatively impacted by changes in the domestic and global political environment
- DroppedRisks Related to our Business and our Industry
Due to our limited marketing, sales and distribution experience, we may be unsuccessful in our efforts to sell our products
Balancing research and development with commercial operations for CytoSorb.
- DroppedRisks Related to our Business and our Industry
Weakness in the global economy, and in particular in the United States and Europe, could negatively impact our revenue and operating results
- DroppedRisks Related to our Business and our Industry
Our business may be negatively affected if the United States and/or the countries in which we sell our products participate in wars, military actions or are otherwise the target of international terrorism
- DroppedRisks Related to our Business and our Industry
Our Board of Directors may, without stockholder approval, issue and fix the terms of shares of preferred stock and issue additional shares of common stock adversely affecting the rights of holders of our common stock
- DroppedRisks Related to our Business and our Industry
Anti-takeover provisions in our charter documents and under Delaware law could prevent or delay transactions that our stockholders may favor and may prevent stockholders from changing the direction of our business or our management
Risks related to patent law changes and foreign patent enforcement difficulties.
- DroppedRisks Related to our Business and our Industry
Compliance with changing corporate governance and public disclosure regulations may result in additional expense
- DroppedRisks Related to our Business and our Industry
Our common stock is thinly traded on The Nasdaq Capital Market exchange and no assurances can be made about stock performance, liquidity, or maintenance of our Nasdaq listing
- DroppedRisks Related to our Business and our Industry
Future sales of our common stock may cause our share price to fall
Reworded
- 95% rewrittenRisks Related to our Business and our Industry
Cyberattacks and other security breaches could compromise our proprietary and confidential information which could harm our business and reputation
Updated to explicitly include phishing and sophisticated cyberattacks within remote working environments.
- 93% rewrittenRisks Related to our Business and our Industry
Economic downturns, international trade disruptions, wars, terrorism, and geopolitical conflicts could materially and adversely affect our business and operating results
Expanded geopolitical conflicts to name evolving disputes in Iran, Israel, and potential US tariffs involving China, Canada, and Mexico.
Was: Significant economic downturns or international trade disruptions or disputes could adversely affect our business and operating results
- 93% rewrittenRisks Related to our Business and our Industry
A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations
Added specific references to clinical trial enrollment hurdles, patient access limits, and staffing shortages during a pandemic.
- 75% rewrittenRisks Related to our Business and our Industry
The price of our common stock has been highly volatile due to factors that will continue to affect the price of our stock
Updated share price trading range figures, showing a drop from a 2024 high of $1.55 to a 2025 high of $1.31 and ending 2025 at $0.64.
- 72% rewrittenRisks Related to our Business and our Industry
Our operating results are subject to seasonal fluctuation
Added a concluding sentence noting that the company is currently commercializing some of its products despite a historical R&D focus.
- 47% rewrittenRisks Related to our Business and our Industry
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
Added specific product names including ECOS-300CY, PuriFi, VetResQ, and DrugSorb-ATR to the market acceptance risk.
- 47% rewrittenRisks Related to our Business and our Industry
We have a history of losses and may incur future losses
Updated accumulated deficit to $312.2M and 2025 net loss to $8.2M, adding a goal of reaching breakeven through sales expansion and cost controls.
Was: We have a history of losses and expect to incur substantial future losses
- 40% rewrittenRisks Related to our Business and our Industry
If we fail to maintain the CE Mark in the European Union, we will not be able to commercially sell and market CytoSorb
Retained the core risk regarding the transition from the Medical Devices Directive to the MDR by December 2028 without substantive factual changes.
- 22% rewrittenRisks Related to our Business and our Industry
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
All 32 risk factors
Headings as the filing states them, in filing order.
Risks Related to our Business and our Industry
- 01We have a history of losses and may incur future losses47% rewritten
- 02We 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 operationsNew
- 03As 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 unrestrictedNew
- 04A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations93% rewritten
- 05Our operating results are subject to seasonal fluctuation72% rewritten
- 06If 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
- 07We depend upon key personnel who may terminate their employment with us at any time
- 08We 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, respectivelyNew
- 09discussions with the FDA on the final requirements are complete. Following the new De Novo submission, a regulatory decision would be expected following a typical 150-day review process but may be accelerated or extended depending on interactive discussions with the FDA related to submission questionsNew
- 10Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues47% rewritten
- 11We may face litigation from third parties claiming that our products infringe on their intellectual property rights or seek to challenge the validity of our patents
- 12The expiration or loss of patent protection may adversely affect our future revenues and operating earnings
- 13If we fail to maintain the CE Mark in the European Union, we will not be able to commercially sell and market CytoSorb40% rewritten
- 14We 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
- 15Adverse economic conditions and political or regulatory developments could materially and adversely affect our businessNew
- 16We 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
- 17Certain university and other relationships are important to our business and may potentially result in conflicts of interests
- 18Although 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
- 19Due to our limited resources for marketing, sales and distribution, and our reliance on many different distributors, we may be unsuccessful in our efforts to successfully commercialize our products in one or more countriesNew
- 20Our results of operations can be significantly affected by foreign currency fluctuations and regulations
- 21If 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
- 22The market for our products is rapidly changing and competitive, and new devices and drugs, which may be developed by others, could impair our ability to maintain and grow our business and remain competitive
- 23Our 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
- 24Economic downturns, international trade disruptions, wars, terrorism, and geopolitical conflicts could materially and adversely affect our business and operating results93% rewritten
- 25We could be adversely affected by violations of the Foreign Corrupt Practices Act and similar worldwide anti-bribery laws
- 26We are subject to governmental export and import controls that could impair our ability to compete in international markets due to licensing requirements and subject us to liability if we are not in compliance with applicable laws
- 27Cyberattacks and other security breaches could compromise our proprietary and confidential information which could harm our business and reputation95% rewritten
- 28Our 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
- 29Risks Connected to Our SecuritiesNew
- 30The price of our common stock has been highly volatile due to factors that will continue to affect the price of our stock75% rewritten
- 31Directors, executive officers and principal stockholders own a significant percentage of the shares of common stock, which will limit your ability to influence corporate matters22% rewritten
- 32Our Board of Directors’ authority to issue additional securities and anti-takeover provisions in our governing documents under Delaware law could adversely affect the rights of our common stockholders and discourage or delay a change in controlNew
Other Cytosorbents 10-Ks
- FY2024 10-K risk factors38 risks
Cytosorbents faces heavy accumulated losses and requires ongoing capital raises to fund its cash burn operations. Commercial success depends heavily on the CytoSorb device, particularly within its primary German market. Intellectual property protection, international regulations, and third-party reimbursement strictly dictate commercial viability.
Filed Mar 31, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.