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]

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 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]

Financial Performance - Total revenue for 2023 was $36.3 million, a 5% increase compared to $34.7 million in 2022[39] - CytoSorb product sales were $31.0 million in 2023, a 9% increase from $28.6 million in 2022[39] - Q4 2023 total revenue decreased by 8% to $8.7 million compared to $9.4 million in Q4 2022[42] - Q4 2023 CytoSorb sales decreased slightly by 1% to $7.3 million compared to $7.4 million in Q4 2022[42] - The company has $15.6 million in cash as of December 31, 2023, which is expected to fund operations into the fourth quarter of 2024[43] Operational Highlights - Over 228,000 cumulative CytoSorb treatments have been delivered as of the end of 2023, a 17% increase from the end of 2022[9] - International Direct sales experienced strong growth of 27% to $6 million (19% product sales)[23] - The company expects to launch its new PuriFi pump later this year, following the expiration of the distribution agreement with Nikkiso Europe GmbH in September 2023[12] DrugSorb-ATR and STAR-T Trial - The pivotal STAR-T RCT was selected for a Breakout Presentation at the American Association of Thoracic Surgery (AATS) Annual Meeting[13, 17] - The company plans to submit for regulatory approval of DrugSorb-ATR to the U S FDA and Health Canada in the second half of 2024[13, 17] - The initial U S & Canada Total Addressable Market for Brilinta removal is estimated at $325 million, with a potential of $650 million[18, 19] Product Pipeline and Expansion - The company has received ~$50 million in grants, contracts, and other non-dilutive funds since 2003 for its technology[24] - VetResQ, bringing CytoSorb to veterinary medicine, had a limited but successful launch in 2023, with plans for an integrated all-in-one solution in 2024[33] - HemoDefend-BGA aims to create "universal plasma" and has received over $17 million in funding from the U S Department of Defense[37]

Core Viewpoint - CytoSorbents Corporation reported its financial results for Q1 2025, highlighting strong revenue growth in the EU despite temporary disruptions in Germany, and ongoing efforts to advance its product pipeline, particularly DrugSorb™-ATR, which aims to address life-threatening bleeding in cardiac surgery patients [1][4][5]. Financial Results - Product revenue for Q1 2025 was $8.7 million, a decrease of 3% from $9.0 million in Q1 2024, remaining flat on a constant currency basis [8]. - Gross margin decreased to 71% from 77% in Q1 2024 [8]. - Operating loss improved by 17% to $3.9 million compared to $4.7 million in Q1 2024, reflecting a 12% reduction in operating expenses [8]. - Net loss was $1.5 million or $0.02 per share, compared to a net loss of $6.1 million or $0.11 per share in Q1 2024 [8]. - Adjusted net loss was $3.7 million or $0.06 per share, compared to an adjusted net loss of $3.7 million or $0.07 per share in Q1 2024 [8]. - Adjusted EBITDA loss improved by 17% to $2.7 million compared to a loss of $3.3 million in Q1 2024 [8]. - Total cash, cash equivalents, and restricted cash increased to $13.1 million at March 31, 2025, from $9.8 million as of December 31, 2024 [8]. Business Highlights - The company is focused on bringing DrugSorb™-ATR to the North American market, addressing the unmet need for reducing life-threatening bleeding in patients on Brilinta® during CABG surgery [5][6]. - The FDA issued a denial letter regarding the De Novo Request for DrugSorb-ATR, but the company plans to resolve the outstanding items through a formal appeal process, expecting a final regulatory decision in 2025 [6][7]. - Real-world adoption of DrugSorb-ATR is increasing, with more heart centers incorporating the technology into standard care based on evidence from the international STAR Registry [7]. - The company completed a shareholder rights offering, raising $6.8 million, which increased liquidity and allowed for the release of $5.0 million of restricted cash [9]. Operational Developments - CytoSorbents opened a new regional sales subsidiary in Dubai, UAE, expanding its global footprint into the Middle East and Africa [9]. - The company appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR [9].