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 Viewpoint - CytoSorbents Corporation is making progress in obtaining regulatory approval for its DrugSorb-ATR device, which aims to address significant medical needs in intensive care and cardiac surgery by removing blood thinners to reduce perioperative bleeding [2][3][4]. Regulatory Update - The FDA upheld its previous denial of the De Novo application for DrugSorb-ATR but found no safety issues, indicating a need for additional information to support the desired label indication [2][4]. - The company plans to file a new De Novo application that will include new real-world data supporting the device's clinical performance, which was not available during the original submission [4]. - A pre-submission meeting with the FDA is anticipated in Q4 2025 to confirm requirements for the new application, with a standard regulatory decision expected by mid-2026 [4]. Company Strategy - The company is focused on collaborating with both the FDA and Health Canada to secure marketing authorization for DrugSorb-ATR while also driving growth in its core business [3][4]. - Efforts are being made to improve product gross margins, control costs, and manage the core business towards near breakeven as 2025 concludes [3]. Product Overview - CytoSorbents specializes in blood purification technologies that remove toxic substances from blood, with applications in critical illnesses such as sepsis and trauma [5][6]. - The DrugSorb-ATR system is designed to reduce the severity of perioperative bleeding in high-risk surgeries due to blood-thinning medications and has received FDA Breakthrough Device Designation [7]. Market Presence - CytoSorb, the company's lead product, is approved in the EU and distributed in over 70 countries, with nearly 300,000 devices used cumulatively [6]. - The company has a range of marketed products and ongoing developments protected by numerous patents [8].

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 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]

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 Viewpoint - CytoSorbents Corporation has successfully converted its Net Operating Loss (NOL) and R&D tax credits into $1.7 million in cash through the New Jersey Technology Business Tax Certificate Transfer Program, which will bolster its cash reserves and support ongoing growth initiatives [1][2]. Group 1: Financial Impact - The company received $1.7 million in cash proceeds from the sale of its 2023 and amended 2022 NOL and R&D tax credits [1][2]. - This funding is aimed at strengthening cash reserves and supporting strategic initiatives, including the launch of DrugSorb™-ATR in the U.S. and Canada and scaling up manufacturing at its new Princeton facility [2]. Group 2: Tax Credit Program - The New Jersey Technology Business Tax Certificate Transfer Program allows approved technology and biotechnology businesses with NOLs to sell their unused NOLs and R&D tax credits for at least 80% of their value to profitable corporate taxpayers in New Jersey [3]. - The program enables companies to convert tax losses and credits into cash for various expenditures, enhancing their financial flexibility [3]. Group 3: Legislative Context - New Jersey enacted tax reform legislation on July 3, 2023, allowing taxpayers to immediately deduct R&D expenditures retroactively from January 1, 2022, which increased the NOL available for sale in the NJEDA Program for CytoSorbents [4]. Group 4: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5]. - The company's lead product, CytoSorb®, is approved in the EU and has been used in over 270,000 devices globally, with applications in critical illnesses such as sepsis and liver failure [6]. - CytoSorbents is also developing DrugSorb™-ATR, an investigational device aimed at reducing perioperative bleeding in high-risk surgeries [7].