Accessibility StatementSkip Navigation PRINCETON, N.J., Sept. 16, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today provided a regulatory update on DrugSorbâ"¢-ATR. On August 20, 2025, the Company announced that it had received a U.S. Food and Drug Administration (FDA) appeal decision regarding the FDA's previous denial letter of the Company's De Novo applicat ...

Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents Corporation - **Industry**: Medical Devices, specifically blood purification technology - **Key Products**: - **CytoSorb**: A blood purification device for critical care and cardiac surgery - **DrugSorb-ATR**: An investigational device aimed at reducing perioperative bleeding during CABG surgery Core Points and Arguments - **CytoSorb Product Performance**: - Achieved record sales of **$36.1 million** in the trailing 12 months with **71% gross margins** [6] - CE-marked with nearly **300,000 uses** in over **70 countries** [6] - **DrugSorb-ATR Development**: - Targets a **$300 million** market opportunity, potentially growing to over **$1 billion** [6] - Received two **FDA Breakthrough Device designations** and is in discussions with FDA and Health Canada for marketing approval [6] - **Technology Description**: - Utilizes a **hemocompatible, highly porous polymer bead** for toxin removal, functioning similarly to the liver [7] - Offers a **three-year shelf life** at room temperature and is **gamma sterilizable** [7] - **Market Need**: - Addresses severe inflammation in critical illnesses, impacting **up to 60%** of ICU patients [10] - Sepsis is a leading indication, affecting **49 million** people globally and causing **11 million deaths** annually [13] - **Clinical Efficacy**: - Demonstrated significant improvements in critical illness metrics, including blood pressure and lung function [17] - A meta-analysis showed reduced in-hospital mortality and improved hemodynamic outcomes with CytoSorb treatment [18] - **Regulatory Challenges**: - Received a denial letter from FDA regarding DrugSorb-ATR but is in constructive discussions for a path forward [27] - Health Canada also issued a notice of refusal, citing missed primary endpoints in the broader population but success in CABG patients [28] Financial Performance - **Revenue Growth**: - Reported **$9.6 million** in revenue for Q2, a **9% increase** year-over-year, with **22% growth** in Germany [29] - Maintained **71% gross margins**, consistent with previous periods [30] - **Cash Position**: - Ended Q2 with **$11.7 million** in cash and equivalents, alongside **$15 million** in debt [30] - **Strategic Goals**: - Aiming for near cash flow break-even by the end of 2025 while preparing for DrugSorb-ATR market entry [31] Additional Insights - **Market Positioning**: - CytoSorb is positioned to address a larger patient population in the ICU compared to dialysis, creating a multi-billion dollar market opportunity [11] - **Clinical Registries**: - The **COSMOS Registry** collects real-world data to support the efficacy of CytoSorb in critical care settings [15] - **Future Outlook**: - The company remains committed to driving revenue growth and achieving regulatory approvals for DrugSorb-ATR, emphasizing the importance of treating the right patients at the right time [33]

Company Overview - CytoSorbents Corporation is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3] - The company's proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids [3] - CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries, with nearly 300,000 devices used cumulatively [4] Product Applications - Key applications of CytoSorbents' technologies include the removal of blood thinners during cardiothoracic surgery and the removal of inflammatory agents in critical illnesses such as sepsis and trauma [3] - CytoSorb has received FDA Emergency Use Authorization for use in critically ill COVID-19 patients with respiratory failure [4] Regulatory Developments - The company is seeking FDA and Health Canada marketing authorization for the DrugSorb™-ATR antithrombotic removal system, which has received two FDA Breakthrough Device Designations [5] - In April 2025, the FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, citing deficiencies that need to be addressed [5] - The company is currently evaluating options for appeal with the FDA and has filed a Request for Reconsideration with Health Canada following a Notice of Refusal for its Medical Device License application [7][8] Upcoming Events - Management will present and participate in one-on-one meetings with investors at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1][2]

Core Viewpoint - The FDA upheld the De Novo denial for CytoSorbents' DrugSorb-ATR device but found no safety issues, proposing a potential path forward for market authorization [2][3]. Regulatory Status - On August 14, 2025, the FDA issued a decision following an appeal regarding the De Novo application for DrugSorb-ATR, which was initially denied on April 25, 2025, due to the need for additional information [2][7]. - The FDA's appeal decision confirmed the device's safety but maintained the denial, indicating that further information is required to support the desired label indication [2][3]. - The FDA suggested a potential path forward for market authorization and noted that the company could appeal to a higher level within the FDA [2][7]. Company Insights - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [4][5]. - The company’s lead product, CytoSorb®, is already approved in the EU and has been used in nearly 300,000 devices globally [5]. - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries for patients on blood thinners, having received two FDA Breakthrough Device Designations [7][9]. Market Need - There is a significant need for solutions addressing perioperative bleeding in patients undergoing urgent coronary artery bypass graft (CABG) surgery, particularly those on ticagrelor [3][4]. - The technology aims to mitigate risks associated with blood thinners, which are increasingly common among patients, thereby addressing a critical issue faced by surgeons and patients alike [3][4].

Financial Data and Key Metrics Changes - In Q2 2025, the company reported product sales of $9.6 million, representing a 9% year-over-year increase and a 4% increase on a constant currency basis compared to the same period last year [8][28] - Gross margin performance remained solid at approximately 71% [9][29] - The operating loss for Q2 was approximately $3.6 million, flat year-over-year, with a net income of $1.9 million compared to a net loss of $4.3 million in the prior year [30][31] Business Line Data and Key Metrics Changes - The German commercial team saw a 22% year-over-year growth, contributing to overall positive performance [8][28] - Distributor sales were among the best ever, second only to a record second quarter last year [9][28] Market Data and Key Metrics Changes - CytoSorb, the flagship product, has been utilized in nearly 300,000 devices across more than 70 countries, driving significant sales [6] - The company is navigating the regulatory process for DrugSorb ATR, with final decisions expected this year [6][18] Company Strategy and Development Direction - The company aims to drive its core business towards near breakeven by the end of 2025 while preparing for the North American commercial launch of DrugSorb ATR [8][32] - The strategic realignment of the German commercial team is expected to lead to stronger execution and improved performance [9][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the appeals process for DrugSorb ATR, highlighting the strengths of their application and external expert support [39][40] - The company remains optimistic about final regulatory decisions from both the FDA and Health Canada, expected before the end of 2025 [17][18] Other Important Information - The company is actively preparing for a potential North American commercial launch of DrugSorb ATR later this year and into 2026 [32][34] - September is designated as Sepsis Awareness Month, with the company participating in initiatives to highlight the treatment of sepsis and septic shock [21][22] Q&A Session Summary Question: Can you provide more confidence regarding the regulatory submissions? - Management highlighted the positive aspects of the appeals process and the support from external cardiac surgery experts, expressing hope for a favorable FDA response soon [39] Question: Update on Germany's performance and organizational changes? - Management noted a 22% increase in the second quarter and emphasized that the reorganization is a work in progress aimed at improving efficiency [41][43] Question: Clarification on the reconsideration request in Canada? - The company clarified that the request for reconsideration is part of a formal appeals process similar to that with the FDA [48] Question: What is the rollout strategy for DrugSorb ATR in the U.S.? - The rollout will be purposeful, focusing on clinical accounts that participated in the study and a few others, with an emphasis on understanding the pace of adoption [50] Question: How does the sepsis and septic shock data affect the business model? - Management indicated that sepsis and septic shock are core applications for CytoSorb, accounting for a significant portion of critical care revenue, and emphasized the need for effective treatment strategies [51][52] Question: Expectations for gross margins in Q3 and Q4? - Management expressed that while gross margins have been stable, there are opportunities to improve efficiencies and potentially increase margins with the approval of DrugSorb ATR [55]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, highlighting a **going concern** warning - The company's cash position of approximately **$11.7 million** (including restricted cash) as of June 30, 2025, raises **substantial doubt** about its ability to continue as a **going concern**[20](index=20&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheet shows increased cash and total assets, stable liabilities, and higher stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,204 | $3,280 | | Total current assets | $22,987 | $21,604 | | Total assets | $47,990 | $47,372 | | **Liabilities & Equity** | | | | Total current liabilities | $9,842 | $9,825 | | Long-term debt | $14,377 | $13,996 | | Total liabilities | $36,404 | $36,265 | | Total stockholders' equity | $11,586 | $11,107 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q2 2025 net income marks a turnaround from Q2 2024 loss, driven by a significant foreign currency gain Key Operating Results (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $9,617 | $8,842 | $18,344 | $17,831 | | Gross Profit | $6,814 | $6,503 | $13,021 | $13,376 | | Loss from Operations | ($3,615) | ($3,570) | ($7,502) | ($8,227) | | Gain (loss) on foreign currency | $6,178 | ($544) | $9,192 | ($1,970) | | Net Income (Loss) | $1,947 | ($4,294) | $469 | ($10,384) | | Diluted EPS | $0.03 | ($0.08) | $0.01 | ($0.19) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved, with financing activities leading to a net increase in cash Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,975) | ($9,624) | | Net cash used in investing activities | ($179) | ($246) | | Net cash provided by financing activities | $6,831 | $9,263 | | Net change in cash, cash equivalents, and restricted cash | $1,962 | ($671) | | Cash, cash equivalents, and restricted cash – end of period | $11,726 | $14,944 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail financial statements, including business, **going concern** warning, policies, revenue, and financing - In January 2025, the company closed a **Rights Offering**, raising gross proceeds of **$6.25 million** (**$5.4 million** net). An additional **$1.6 million** in gross proceeds (**$1.4 million** net) was raised in February 2025 from the exercise of **Series A warrants**[39](index=39&type=chunk)[43](index=43&type=chunk) - The company has a **loan agreement with Avenue Capital Group** for up to **$20 million**. Tranche **1** of **$15 million** has been funded. A second tranche of up to **$5 million** is available through December 31, 2025, contingent upon receiving **FDA marketing approval** for its **DrugSorb-ATR application**[69](index=69&type=chunk) Revenue by Geography for Six Months Ended June 30, 2025 (in thousands) | Region | Direct Sales | Distributors/Partners | Total | | :--- | :--- | :--- | :--- | | United States | $124 | $0 | $124 | | Germany | $6,151 | $0 | $6,151 | | All other countries | $4,098 | $7,971 | $12,069 | | **Total** | **$10,373** | **$7,971** | **$18,344** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity challenges, and regulatory setbacks for DrugSorb-ATR - The **FDA issued a denial letter** in April 2025 for the company's **De Novo Request for DrugSorb-ATR**. The company is pursuing a **formal appeal** and expects a final regulatory decision in 2025[97](index=97&type=chunk) - **Health Canada issued a Notice of Refusal** for the company's **Medical Device License application** for DrugSorb-ATR in June 2025. The company has filed a "**Request for Reconsideration**"[98](index=98&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q2 2025 revenue increased, gross margin decreased, and a foreign currency gain drove net income for H1 Revenue and Gross Profit Comparison (in thousands) | Period | Revenue | % Change | Gross Profit | Gross Margin | | :--- | :--- | :--- | :--- | :--- | | **Q2 2025** | $9,617 | **8.8%** | $6,814 | **70.9%** | | Q2 2024 | $8,842 | - | $6,503 | **73.5%** | | **H1 2025** | $18,344 | **2.9%** | $13,021 | **71.0%** | | H1 2024 | $17,831 | - | $13,376 | **75.0%** | - The decrease in R&D expenses for the six months ended June 30, 2025, was driven by the completion of the **STAR-T clinical trial** and other cost reductions[113](index=113&type=chunk) - A **gain on foreign currency transactions** of **$9.2 million** for H1 2025 was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar during the period[115](index=115&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Cash position raises **substantial doubt** about going concern, with future capital dependent on regulatory approvals - The company's cash position of **$11.7 million** as of June 30, 2025, raises **substantial doubt** about its ability to continue as a **going concern**[122](index=122&type=chunk) - The company has an **effective shelf registration statement** to raise up to **$150 million**, with approximately **$149.7 million** available as of June 30, 2025. It also has an **ATM facility** with **$19.4 million** available[118](index=118&type=chunk) - In early 2025, the company raised a total of **$6.8 million** in **net** proceeds from a **Rights Offering** and subsequent warrant exercises, which also satisfied a **debt covenant** to **unrestrict $5 million of cash**[119](index=119&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is **not required to provide** market risk disclosures - As a smaller reporting company, CytoSorbents is **not required to provide** quantitative and qualitative disclosures about market risk[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective due to a **material weakness** in accounting for stock-based compensation - Disclosure controls and procedures were concluded to be ineffective as of June 30, 2025, due to a **material weakness** in internal controls[132](index=132&type=chunk) - The identified **material weakness** relates to controls over the accounting for Restricted Stock Units (RSUs), specifically ensuring grants and vesting activities were recorded in the proper accounts and at the proper amounts[135](index=135&type=chunk) - Management has begun implementing a remediation plan, including redesigning control procedures and enhancing documentation, with the expectation of full implementation during the fiscal year ending December 31, 2025[136](index=136&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not currently involved** in any legal proceedings expected to have a material adverse effect - The company is **not currently involved** in any legal proceedings expected to have a material adverse effect on its business[141](index=141&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Primary risk is failing to obtain FDA or Health Canada authorization for DrugSorb-ATR, materially harming revenue - A **primary risk is the potential failure** to obtain regulatory authorization for DrugSorb-ATR in the U.S. and Canada. The **FDA issued a denial letter** on April 25, 2025, and **Health Canada issued a Notice of Refusal** on June 26, 2025[144](index=144&type=chunk)[145](index=145&type=chunk) - The company is actively pursuing an appeal with the FDA through a supervisory review process and has filed a "**Request for Reconsideration**" with Health Canada[144](index=144&type=chunk)[145](index=145&type=chunk) - An **unsuccessful appeal could significantly impact** the company's ability to generate substantial sales of its product candidates in the U.S. and Canada[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports **no unregistered sales** of equity securities during the period - **None**[150](index=150&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) Chief Medical Officer adopted a Rule 10b5-1 trading plan to sell incentive stock options - On June 13, 2025, the **Chief Medical Officer adopted a Rule 10b5-1 trading plan** to sell up to **157,500 incentive stock options**[153](index=153&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) Exhibits include CEO and CFO certifications and XBRL interactive data files - The exhibits include **certifications from the CEO and CFO** pursuant to **Sections 302 and 906 of the Sarbanes-Oxley Act**, and **XBRL interactive data files**[158](index=158&type=chunk)

Core Insights - CytoSorbents Corporation emphasizes the critical role of CytoSorb® therapy in treating sepsis and septic shock, showcasing new studies that indicate improved clinical outcomes when used early and intensively [1][2][12] - The company is hosting a World Sepsis Day Global Webinar on September 10, 2025, to discuss best practices and the impact of CytoSorb therapy in combating sepsis [1][12] Sepsis and Septic Shock Overview - Sepsis affects approximately 49 million people globally each year, resulting in 11 million deaths, which accounts for up to 20% of all global deaths [3] - Standard treatments for septic shock often fall short, with mortality rates ranging from 30% to 50%, especially in cases of multiple organ failure [4] CytoSorb Therapy - CytoSorb® is a first-in-class blood purification therapy approved in the EU, with nearly 300,000 treatments administered across over 70 countries [5][15] - The therapy utilizes advanced porous polymer beads to remove a variety of toxic substances from the bloodstream, including inflammatory cytokines and bacterial toxins [5][14] - CytoSorb's broad-spectrum approach addresses multiple aspects of sepsis, aiming to break the cycle of inflammation, restore blood flow, repair blood vessels, manage fluid overload, and prevent organ failure [6][11] Clinical Evidence - Clinical studies support the efficacy of early and intensive use of CytoSorb, with a 74% survival rate reported in a study of critically ill COVID-19 patients [8] - A retrospective study indicated that early and intensive CytoSorb use nearly doubled survival rates in septic shock patients [9] - A meta-analysis involving 744 patients demonstrated significant improvements in hemodynamics and survival rates when CytoSorb was used alongside standard care [10] Company Mission and Future Directions - CytoSorbents aims to improve treatment outcomes for sepsis and septic shock, guided by clinical insights and a growing body of evidence [12] - The company is actively engaged in regulatory processes for its DrugSorb™-ATR system in the U.S. and Canada, which aims to reduce perioperative bleeding [16][17]

Core Insights - CytoSorbents Corporation will report its second quarter 2025 financial results and business highlights on August 7, 2025, with a live conference call scheduled for 4:30 PM ET [1][2] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3] - The company's proprietary technology utilizes biocompatible, highly porous polymer beads to remove toxic substances from blood and bodily fluids [3] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and distributed in over 70 countries, with more than 270,000 devices used to date [4] Product Development - The company is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [5] - A De Novo Request for DrugSorb-ATR was submitted to the FDA in September 2024, but was denied in April 2025 due to identified deficiencies [5][6] - The company plans to resolve these deficiencies through a formal appeals process, with an appeal hearing scheduled for late August 2025 [6] Regulatory Challenges - In Canada, the company faced a Notice of Refusal for its Medical Device License application, with plans to file a Request for Reconsideration [7] - DrugSorb-ATR has not yet been authorized for commercialization in the U.S. or Canada [8] Intellectual Property - CytoSorbents holds numerous patents and trademarks for its blood purification technologies, with multiple products under development [9]

Core Viewpoint - CytoSorbents Corporation is actively pursuing regulatory approvals for its DrugSorb™-ATR device, aimed at reducing perioperative bleeding in patients undergoing CABG surgery who are on the antiplatelet drug Brilinta® [1][4] Regulatory Updates - The FDA has scheduled an appeal hearing for CytoSorbents' supervisory review of its De Novo Request, with expectations to resolve deficiencies by the end of August 2025 [2] - Health Canada issued a Notice of Refusal for the Medical Device License application, prompting the company to file a Request for Reconsideration by July 25, 2025 [3] Product Overview - DrugSorb-ATR is designed to address a significant need in cardiac surgery by mitigating bleeding risks associated with Brilinta® [4] - The device has received FDA Breakthrough Device Designation for removing ticagrelor and other direct oral anticoagulants during cardiothoracic procedures [8] Company Background - CytoSorbents specializes in blood purification therapies for critical conditions, utilizing proprietary polymer bead technology to remove toxins from blood [5] - The company's lead product, CytoSorb®, is already approved in the EU and has been used over 270,000 times globally [6]

Core Viewpoint - CytoSorbents Corporation has filed a request for supervisory review with the FDA regarding the De Novo Denial Letter for its DrugSorb-ATR Device, which aims to reduce bleeding severity in CABG surgery patients on Brilinta® [1][2][7] Group 1: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5] - The company's proprietary technologies utilize biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including sepsis and organ failure [5][6] - CytoSorbents' lead product, CytoSorb®, is CE Marked in the EU and has been used over 270,000 times globally [6] Group 2: Regulatory Developments - The FDA issued a De Novo Denial Letter on April 25, 2025, citing deficiencies that must be resolved before the DrugSorb-ATR can be authorized for U.S. commercialization [2][7] - The company has engaged with the FDA to clarify these deficiencies and believes that the supervisory review process will effectively address the concerns [2][4] - The appeals process typically results in a final decision approximately 60 days after filing, with the company optimistic about receiving a regulatory decision in 2025 [3][7] Group 3: Market Context - DrugSorb-ATR is designed to mitigate perioperative bleeding in patients undergoing high-risk surgeries while on antithrombotic medications [7] - The application for DrugSorb-ATR is also under advanced review by Health Canada, with the agency committed to issuing a decision despite current delays [4][7]