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, ...

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 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]

Financial Performance - CytoSorbents' product revenue in Q3 2024 reached $8.6 million, showing an 11% year-over-year growth[16] - The company's operating expenses decreased by 25% year-over-year in Q3 2024[16,51] - The operating loss was reduced by 40% year-over-year[16,51] - Cash burn was reduced to $2.7 million in Q3 2024, down from $5 million in Q2 2024[16,54] - As of September 30, 2024, the company had $12.2 million in cash, including $6.5 million of restricted cash and $5.7 million in unrestricted cash[57] DrugSorb-ATR Regulatory and Clinical Updates - DrugSorb-ATR, an investigational device, has been submitted to the FDA and Health Canada, with regulatory decisions expected in 2025[12,21] - The company submitted a De Novo medical device marketing application to the FDA on September 27, 2024, which was accepted in October 2024[22] - In isolated CABG patients, the intraoperative use of DrugSorb-ATR was associated with reduced bleeding severity[20] - Real-world evidence from an additional 102 CABG patients on Brilinta suggests that the guideline-recommended washout period of a minimum of 72 hours may be substantially shortened with CytoSorb and DrugSorb-ATR[23] Market Opportunity - The company estimates an initial market opportunity of over $300 million for Ticagrelor removal in CABG in the U S and Canada[31]

Financial Performance - Q1 2025 product sales were $8.7 million, a 3% year-over-year decrease, but flat on a constant currency basis[18] - Product gross margin was 71% in Q1 2025, consistent with the average from 2024[18] - Total operating expenses decreased by 12% year-over-year, from $11.5 million to $10.1 million[50] - Net loss improved by 17% year-over-year, from $6.1 million ($0.11/share) to $1.5 million ($0.02/share)[50] DrugSorb-ATR Regulatory Update - The company submitted a De Novo submission to the FDA and a Medical Device License application to Health Canada, but received a denial letter from the FDA on April 25, 2025[36] - The company plans to file a formal appeal within 60 days of the FDA letter[36] - Health Canada submission is in advanced review, with a decision expected in 2025[36] DrugSorb-ATR Market Opportunity - DrugSorb-ATR addresses a $300+ million initial market opportunity, which could exceed $1 billion as Brilinta becomes generic and DrugSorb-ATR expands to additional indications[33] CytoSorb Core Business - Core product sales reached a record $35.6 million in 2024[14] - The company aims to return Germany to growth in the second half of 2025 after flat sales for two consecutive years[18] - The company is managing its total core business toward near breakeven in the second half of 2025[18] Balance Sheet - The company received $6.8 million from a successful Rights Offering[51] - The company released $5.0 million of restricted cash[51] - The company had $13.1 million in cash, cash equivalents, and restricted cash at March 31, 2025[51]

Core Viewpoint - CytoSorbents Corporation has extended the expiration date of its Series B Right Warrants from April 10, 2025, to June 10, 2025, allowing more time for warrant holders to exercise their rights [1] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4] - The company’s proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids [4] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and distributed in over 70 countries, with more than 250,000 devices used cumulatively [5] Product and Technology Details - CytoSorb® is designed for applications such as removing blood thinners during cardiothoracic surgery and inflammatory agents in critical illnesses like sepsis and liver failure [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 [6] - CytoSorbents holds numerous patents and trademarks for its blood purification technologies, with several products under development [7] Financial and Investment Information - The Series B Right Warrants can be exercised at a price equal to 90% of the 5-day volume weighted average price of the common stock, with a minimum price of $2.00 and a maximum of $4.00 [2] - Approximately 4.8 million shares of common stock are reserved for the exercise of the Series B Right Warrants, which will expire worthless if not exercised [3]