Accessibility StatementSkip Navigation PRINCETON, N.J., Sept. 29, 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, announced today its strong scientific presence at the upcoming European Association for Cardio- Thoracic Surgery (EACTS) Annual Meeting, the world's largest gathering for the global cardiothoracic community, taking place October 8–11, 2025 in Copenhagen, ...

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].

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].

Company Appointment - CytoSorbents Corporation announced the appointment of Melanie Grossman as Vice President and Corporate Controller, bringing over 25 years of finance and accounting experience in publicly-traded companies [1][2] - The Chief Financial Officer, Peter J. Mariani, highlighted Ms. Grossman's expertise in financial operations, planning, analysis, and regulatory compliance as beneficial for the company's growth and efficiency [2] Inducement Grants - The Compensation committee approved inducement awards for Ms. Grossman under Nasdaq Listing Rule 5635(c)(4), with terms subject to applicable award agreements and vesting conditions [3] Company Overview - CytoSorbents is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4] - The proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various critical illnesses such as sepsis and liver failure [4] Product Development - The lead product, CytoSorb®, is approved in the EU and used in over 70 countries, with more than 270,000 devices utilized to date [6] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients, although it is not yet approved in the U.S. [6] Future Products - CytoSorbents is developing DrugSorb™-ATR, an investigational device aimed at reducing perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [7] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR, which is currently under substantive review [7] Intellectual Property - The company holds numerous patents and trademarks for its blood purification technologies, with multiple products under development [8]