Summary of CytoSorbents Fireside Chat - December 15, 2025 Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Biotechnology, specifically medical devices focused on blood purification - **Key Products**: - **CytoSorb**: Removes cytokines and toxic substances from blood - **DrugSorb-ATR**: Investigational product aimed at removing blood thinners Core Points and Arguments - **Product Mechanism**: CytoSorb utilizes a highly porous polymer bead technology to extract toxic materials from blood without the need for affinity agents, making it compatible with existing hospital blood pumps [6][7] - **Market Presence**: CytoSorb is EU-approved and sold in over 70 countries, with more than 300,000 human treatments conducted to date, generating approximately $37 million in trailing 12-month revenue [9][10] - **Gross Margins**: The product has a gross margin of about 71%, with potential for higher margins as the U.S. market is pursued [10] - **Regulatory Strategy**: The company is focusing on the U.S. market for DrugSorb, which has received two FDA breakthrough device designations due to the significant unmet medical need for managing perioperative bleeding in patients on blood thinners [11][22] - **Clinical Trials**: The START trial, a randomized controlled trial involving 140 patients, aimed to demonstrate the efficacy of DrugSorb in reducing perioperative bleeding but missed its primary endpoint due to trial design issues [41][51] - **Regulatory Discussions**: The FDA has acknowledged the safety of the device and is open to a new De Novo submission that includes real-world evidence to support efficacy [58][62] Financial Management - **Cash Flow Strategy**: The company aims to achieve cash flow break-even by early 2026, with a refinancing agreement providing additional cash and extending the interest-only period on debt [70][71] - **Market Opportunity**: The total addressable market for DrugSorb is estimated at $300 million, potentially growing to over $1 billion as additional blood thinners and surgeries are included [26] Pipeline and Future Prospects - **Product Pipeline**: In addition to CytoSorb and DrugSorb, the company has products like VetRescue for animals and HemoDefend-BGA for universal plasma, indicating a broadening of its product offerings [12][13] - **Launch Strategy**: Upon FDA approval, the company plans a targeted launch in the U.S., focusing on clinical sites that have shown interest in the product [73][74] - **Regulatory Outlook**: The company expects to submit a new De Novo application in early 2026, with the potential for approval within the same year [64][65] Additional Insights - **Market Challenges**: The company faces challenges typical of microcap biotech firms, including the need for substantial resources for clinical trials and regulatory approvals [51][52] - **Surgeon Interest**: There is significant interest from surgeons in the U.S. for a solution to manage bleeding risks associated with blood thinners during surgeries, which could facilitate a successful product launch [74] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's current status, regulatory strategies, financial management, and future prospects in the biotechnology industry.

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 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 is focused on bringing DrugSorb™-ATR to market as a solution for preventing life-threatening bleeding in CABG patients treated with Brilinta® [3] - The FDA issued a denial letter for the De Novo Request for DrugSorb-ATR, citing deficiencies that need to be addressed before commercialization can proceed [2] - The company is committed to resolving the issues with the FDA and anticipates a final regulatory decision in 2025 [3] Company Overview - CytoSorbents Corporation specializes in blood purification therapies for critical conditions in intensive care and cardiac surgery [4] - The company’s technologies utilize biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios [4] - CytoSorbents has a lead product, CytoSorb®, which is approved in the EU and used in over 70 countries, with over 270,000 devices utilized to date [5] Product Development - DrugSorb-ATR is an investigational device aimed at reducing perioperative bleeding in high-risk surgeries due to blood thinners [6] - The device has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants [6] - The company submitted a De Novo Request for DrugSorb-ATR in September 2024, which was accepted for review in October 2024 [6] Regulatory Challenges - The FDA's denial letter highlighted remaining deficiencies that must be resolved for DrugSorb-ATR to be authorized for commercialization [2] - CytoSorbents plans to engage in ongoing discussions with the FDA and will file a formal appeal if necessary [2]

Core Insights - CytoSorbents Corporation has appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR in the U.S. and Canada, anticipating marketing approval [1][2] - DrugSorb-ATR is positioned to address perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta® [2][3] - The company expects regulatory decisions from the U.S. FDA and Health Canada regarding DrugSorb-ATR in 2025, with the device currently classified as investigational [3][8] Company Overview - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [5][6] - The company's proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including cardiothoracic surgery [5][6] - CytoSorbents' lead product, CytoSorb®, is already approved in the European Union and has been used in over 70 countries, with more than 250,000 devices utilized to date [7] Product Development - DrugSorb-ATR is an investigational device designed to reduce perioperative bleeding severity in high-risk surgeries due to blood thinners, having received two FDA Breakthrough Device Designations [8] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR in September 2024, which is currently under substantive review [8] - CytoSorbents has a range of products under development based on its blood purification technology, protected by numerous patents [9]