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]

PRINCETON, N.J., June 24, 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, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSo ...

The Emergence of CytoSorbents Corporation Nasdaq: CTSO Q3 2024 Earnings Conference Call November 7, 2024 DrugSorb-ATR is an investigational device currently under U.S. FDA and Health Canada review. It is not yet approved or cleared in any country. Conference Call Participants Moderator: Adanna Alexander, PhD ICR Healthcare Efthymios "Makis" Deliargyris MD, FACC, FESC, FSCAI Chief Medical Officer Christopher Cramer, MS, MBA Senior VP Business Development 2 Phillip Chan, MD, PhD Chief Executive Officer Vincen ...

CytoSorbents Corporation Nasdaq: CTSO Q1 2025 Financial Results and Recent Business Highlights Conference Call May 14, 2025 Conference Call Participants Phillip Chan, MD, PhD Chief Executive Officer Moderator: Adanna Alexander, PhD VP Investor Relations, ICR Healthcare Efthymios "Makis" Deliargyris MD, FACC, FESC, FSCAI Chief Medical Officer Peter J. Mariani, CPA Chief Financial Officer 2 Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries ...

Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents - **Industry**: Medical Supplies and Devices - **Key Products**: - **CytoSorb**: Blood purification technology for critical care and cardiac surgery - **DrugSorb ATR**: Investigational product for reducing perioperative bleeding during CABG surgery Core Points and Arguments 1. **CytoSorb Product Performance**: - Achieved record core non-COVID product sales of $35.6 million in 2024, growing 15% year-over-year [3] - Over 270,000 human treatments in more than 70 countries [3] - High gross margins of 71% [27] 2. **DrugSorb ATR Development**: - Designed to address bleeding complications in patients on blood thinners during surgery [11] - Received two FDA breakthrough device designations [14] - Aimed at a significant unmet medical need in the US and Canadian markets [3] 3. **Technology and Mechanism**: - Utilizes a patented polymer bead technology that effectively removes a broad range of harmful substances from blood [4] - CytoSorb targets severe inflammation, which affects up to 60% of ICU patients [7] 4. **Clinical Research and Efficacy**: - Recent studies show significant reductions in mortality and shock reversal in patients treated with CytoSorb [8][10] - Meta-analysis indicated a 50% reduction in 28-day all-cause mortality in patients treated with CytoSorb [10] 5. **Regulatory Updates**: - FDA denial letter received on April 25, 2025, but the company plans to file a formal appeal [23][24] - Health Canada submission is under advanced review, with expectations for decisions in 2023 [25] 6. **Market Potential**: - Total addressable market estimated at $300 million initially, potentially growing to over $1 billion with additional indications [26] 7. **Financial Position**: - Cash position of $13.1 million at the end of Q1, with a quarterly burn rate of $2.5 million to $3 million [46] - Aiming for cash flow breakeven by the second half of 2025 [28] 8. **Sales Strategy**: - Plans for a controlled market release in clinical trial centers post-approval, followed by a broader launch in 2026 [36] - Predominantly direct sales force in the US, complemented by perfusionist distributors [37] 9. **Challenges in Germany**: - Germany accounts for about 40% of revenue but has seen flat growth due to macroeconomic factors [52] - Organizational changes are being made to drive deeper into accounts and improve sales effectiveness [53] Additional Important Information - **Cost Savings for Hospitals**: - Using DrugSorb can save hospitals $18,000 to $30,000 per patient by reducing the need for prolonged ICU stays to wash out blood thinners [43] - **Clinical Trial Insights**: - The STAR T trial showed that DrugSorb ATR significantly reduced bleeding severity in CABG patients [19] - **Market Preparation**: - The company is actively preparing for market entry while awaiting regulatory decisions [31] This summary encapsulates the key points discussed during the conference call, highlighting the company's product performance, regulatory challenges, market potential, and strategic direction.

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $8,700,000, a 3% decrease compared to $9,000,000 in Q1 2024, but flat on a constant currency basis [31][32] - Gross margin for the quarter was 71%, consistent with the full year 2024, but lower than 76% in Q1 2024 due to a 23% reduction in units produced [32] - Operating loss improved by 17% to $3,900,000 compared to $4,700,000 in 2024, driven by a 12% reduction in operating expenses [32][33] - Net loss for the quarter was $1,500,000 or $0.02 per share, compared to $6,100,000 or $0.11 per share in the prior year [33] Business Line Data and Key Metrics Changes - Core product sales for CytoSorb in Q1 2025 were $8,700,000, representing a 3% year-over-year decline, but constant currency sales were approximately the same as the previous year [9][10] - International distribution and other direct sales markets showed strong performance, offsetting temporary disruptions in the German direct sales segment [10] Market Data and Key Metrics Changes - Germany accounts for approximately 40% of the company's sales, and efforts are underway to return to growth in this critical market after two years of flat performance [16] - The company is focusing on expanding its presence in Dubai to access high-growth markets in the Middle East and Africa [17] Company Strategy and Development Direction - The company aims to achieve near breakeven by the end of 2025 while preparing for the anticipated launch of DrugSorb ATR in the U.S. and Canada [35][39] - Key growth catalysts include publicizing new clinical data, simplifying customer messaging, and returning German sales to growth [14][16] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their submission for DrugSorb ATR and the potential for a positive outcome from the FDA appeal process [46][47] - The company is actively preparing for the potential commercial launch of DrugSorb ATR, emphasizing the importance of real-world data and clinical evidence [27][39] Other Important Information - The company raised $6,800,000 through a shareholder rights offering, which increased available liquidity and allowed for the release of $5,000,000 of restricted cash [33][34] - The company welcomed a new Vice President of Marketing for North America to lead the strategy for DrugSorb ATR [29][30] Q&A Session Summary Question: Can you talk about your level of confidence in getting clearance for DrugSorb ATR? - Management expressed strong confidence in the strength of their submission and the compelling data from the STAR T trial, believing the chances during the appeal process are good [46][47] Question: What happens if the appeal is denied? - Management indicated that if the appeal is unsuccessful, they could continue with a new de novo submission using a large portion of the original submission, which would result in a shorter review time [47][48] Question: Will the clinical data help with marketing or reimbursement in Europe? - Management confirmed that strong clinical data is crucial for supporting reimbursement and health technology assessment decisions in the EU [51] Question: Are there any updates on other products in development besides CytoSorb and DrugSorb ATR? - Management stated that the primary focus is currently on DrugSorb ATR, with other technologies like HemoDefend VGA being discussed for the future [60] Question: What is the visibility into the conditions in Germany for growth? - Management acknowledged the unique challenges in Germany but expressed optimism about the changes being implemented to drive operational efficiency and expected benefits in the second half of the year [66]

PRINCETON, N.J., May 1, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device.  DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZene ...

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].

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]

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]