Core Insights - CytoSorbents Corporation reported a transitional year in 2025, achieving a revenue of $37.1 million, a 4% increase year-over-year, and a gross margin of 71% [3][4]. - The company is focused on achieving cash flow breakeven in the second half of 2026, supported by a strategic workforce and cost reduction program [2][26]. Financial Performance - Full-year revenue for 2025 was $37.1 million, up from $35.6 million in 2024, with a gross margin improvement from 70% to 71% [4]. - The operating loss improved by 10% to $14.7 million in 2025 compared to $16.5 million in 2024, while the net loss decreased to $8.2 million or $0.13 per share from $20.7 million or $0.38 per share in 2024 [4][24]. - In Q4 2025, revenue was $9.2 million, a 1% increase year-over-year, with a gross margin of 74% compared to 70% in Q4 2024 [4][5]. Business Highlights - The company has made significant progress in sales performance, with a 13% increase in direct sales outside Germany and an 11.4% increase in distributor sales, which together accounted for approximately 68% of total sales [5]. - CytoSorbents surpassed 300,000 cumulative CytoSorb treatments globally by the end of 2025, indicating broad adoption of its therapy across over 70 countries [6]. - The company is actively engaging with the FDA regarding a new De Novo application for DrugSorb-ATR, which aims to reduce serious perioperative bleeding in patients treated with blood thinners [15][17]. Clinical Momentum - New clinical data supports the use of CytoSorb in critical care, particularly for sepsis and septic shock, with significant reductions in inflammatory markers and improved patient outcomes reported in various studies [7][9]. - A recent multinational survey indicated that over 75% of physicians use extracorporeal blood purification primarily for refractory septic shock, with CytoSorb being the most preferred modality [9]. Regulatory Updates - The FDA confirmed no safety concerns regarding DrugSorb-ATR but required additional information for the proposed label indication, leading to a decision to submit a new De Novo application [17][18]. - The company anticipates a regulatory decision within a typical 150-day review period following the new submission [18]. Strategic Initiatives - The company implemented a strategic workforce and cost reduction program in Q4 2025, reducing headcount by 10% to lower expenses and realign operational spending [25]. - CytoSorbents aims to leverage clinical evidence to educate users on effective treatment strategies, which is expected to support sustained growth across all sales channels [14].

Core Insights - CytoSorbents Corporation has launched HotSwap™, a new system designed to enhance the efficiency of blood purification therapy for critically ill patients, allowing for rapid and safe device exchanges during treatment [1][3][5] - The company has renewed its strategic partnership with Aferetica Srl in Italy, which has been instrumental in the adoption of CytoSorb technology in critical care and organ transplantation [2][3] - New clinical data presented at ISICEM 2026 supports the efficacy of CytoSorb therapy across various critical illnesses, reinforcing its role as a frontline treatment [4][5] Product Launch - HotSwap™ enables seamless exchange of CytoSorb adsorbers, improving treatment timing and reducing the workload on ICU staff [1][3] - The system facilitates the safe return of blood from used devices back to patients, which is crucial for maintaining blood volume during treatment [3] Partnership Renewal - The renewed agreement with Aferetica Srl extends a successful collaboration that has lasted over a decade, focusing on blood purification and organ preservation [2] - Both companies aim to continue expanding their innovations in blood purification and organ transplantation [2] Clinical Evidence - New clinical data presented at ISICEM includes findings from the COSMOS Registry, a Rhabdomyolysis Substudy, and a Meta-Analysis in COVID-19, highlighting the effectiveness of CytoSorb therapy [4][5] - Key outcomes from studies indicate significant improvements in patient survival rates and reductions in inflammatory markers, supporting the therapy's versatility in critical care [6][5]

Financial Results - Fourth quarter 2025 revenue is expected to be approximately $9.2 million, consistent with the fourth quarter of 2024 [5] - Full-year 2025 revenue is expected to be approximately $37.0 million, representing a growth of about 4% compared to $35.6 million for full-year 2024 [5] - Fourth quarter gross margin is expected to be in the range of 73% to 75%, an increase from 71% in the fourth quarter of 2024 and 70% in the third quarter of 2025 [5] - Full-year gross margin is expected to be approximately 72%, compared to 71% for full-year 2024 [5] Business Updates - The pivotal STAR-T study results for DrugSorb®-ATR have been accepted for publication in a top cardiac surgery journal, indicating the clinical relevance of the technology [4][5] - A Pre-Submission Meeting with the FDA is scheduled for this month to discuss the upcoming De Novo Application for DrugSorb®-ATR, with a filing expected by the end of Q1 2026 [4][5] - The company has surpassed 300,000 cumulative CytoSorb treatments worldwide, demonstrating the widespread use of its technology in critical care [6] Strategic Initiatives - The company amended its credit agreement to strengthen its balance sheet, adding $2.5 million in cash and extending the interest-only period through December 31, 2026 [5][6] - A strategic workforce and cost reduction program has been implemented, with expectations to achieve cash-flow breakeven (excluding restructuring payments) in the first quarter of 2026 [6] - Management will host in-person investor meetings during the J.P. Morgan Healthcare Conference in San Francisco [6]

Core Insights - CytoSorbents Corporation is a leader in blood purification technologies for critical care and cardiac surgery, with a focus on treating life-threatening conditions [2][3] - The company reported $37.0 million in high-margin sales over the trailing 12 months, indicating strong financial performance [1] - A key regulatory decision regarding the DrugSorbâ"¢-ATR system is anticipated in mid-2026, which could significantly impact the company's growth trajectory [1][4] Company Overview - CytoSorbents specializes in blood purification using biocompatible polymer beads that remove toxic substances from blood and bodily fluids [2] - The company's lead product, CytoSorb®, is approved in the EU and used in over 70 countries, with nearly 300,000 devices utilized to date [3] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients, although it is not yet approved in the U.S. [3] Product Development - The DrugSorbâ"¢-ATR system is under development to reduce perioperative bleeding in high-risk surgeries, having received two FDA Breakthrough Device Designations [4] - The company has a range of products in development, protected by numerous patents, including ECOS-300CY®, CytoSorb-XL™, and others [5] Upcoming Events - A virtual fireside chat is scheduled for December 15, 2025, to discuss the company's growth and regulatory progress [2]

Core Insights - CytoSorbents Corporation will present and engage in one-on-one meetings with investors at the Jefferies Global Healthcare Conference from November 17-20, 2025 in London [1][9] - The presentation is scheduled for November 18, 2025, at 12:30 PM GMT / 7:30 AM ET, with a live webcast available [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] - Key applications include the removal of blood thinners during cardiothoracic surgery and the elimination of inflammatory agents in critical illnesses such as sepsis and liver failure [3] Product Information - The lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries, with nearly 300,000 devices used to date [4] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients in the U.S., although it is not yet fully approved in the U.S. [4] - 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] Research and Development - CytoSorbents has a range of marketed products and ongoing developments protected by numerous patents and trademarks [6] - The company is actively pursuing regulatory approvals for its products in the U.S. and Canada [5]

Core Insights - CytoSorbents Corporation honors the legacy of Dr. Robert Hawes Bartlett, a pivotal figure in critical care medicine and former Chief Medical Officer, who passed away at age 86 [1][2] - Dr. Bartlett was instrumental in the development and clinical trials of CytoSorb®, a blood purification technology that has been used to treat severe conditions, including during the COVID-19 pandemic [1][3] - The company is advancing its investigational device, DrugSorb™-ATR, aimed at reducing perioperative bleeding in high-risk surgeries [5][6] Company Overview - CytoSorbents Corporation specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery [3] - The company's lead product, CytoSorb®, is approved in the European Union and has been used in nearly 300,000 procedures globally [4] - CytoSorbents is developing additional products, including DrugSorb™-ATR, which has received FDA Breakthrough Device Designations for specific anticoagulant removals [5][6] Contributions of Dr. Bartlett - Dr. Bartlett is recognized as the father of extracorporeal membrane oxygenation (ECMO), a technology that has saved over 100,000 lives worldwide [1][2] - His work included leading clinical trials that supported the approval of CytoSorb® and expanding its use in critical care settings [1][2] - Dr. Bartlett's vision included the combination of CytoSorb with ECMO to enhance treatment for severe acute respiratory distress syndrome (ARDS) [1][2] Future Directions - The company aims to further develop its technologies and expand regulatory approvals for its products in the U.S. and Canada [5][6] - CytoSorbents is focused on leveraging its blood purification technologies to address critical illnesses that currently have limited treatment options [3][4]

Core Insights - CytoSorbents Corporation will have a significant scientific presence at the upcoming EACTS Annual Meeting, showcasing its advancements in blood purification technologies for cardiac surgery [1][2][3] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [10] - The company’s lead product, CytoSorb®, is CE-mark approved in the EU and distributed in over 70 countries, with nearly 300,000 devices used to date [11] - CytoSorbents is also developing the DrugSorb™-ATR system for antithrombotic drug removal, which has received two FDA Breakthrough Device Designations [12] Upcoming Events - The EACTS Annual Meeting will take place from October 8–11, 2025, in Copenhagen, Denmark, expected to attract over 5,000 attendees [1] - CytoSorbents will present two high-profile scientific presentations and host a lunch symposium discussing the role of hemoperfusion technologies in cardiac surgery [2][4] Scientific Presentations - Presentations will include data on the intraoperative removal of direct oral anticoagulants in urgent cardiothoracic surgery and the impact of dual antiplatelet therapy on perioperative bleeding [4][6] - The first randomized controlled trial data will demonstrate the effectiveness of DrugSorb™-ATR in reducing levels of direct oral anticoagulants during urgent cardiac surgery [6] Symposium Topics - The lunch symposium will cover topics such as improving outcomes for endocarditis patients and the combination of VA ECMO with hemoadsorption in cardiogenic shock patients [5][7]

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].

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]