PRINCETON, N.J., July 2, 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 on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting ...

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 Unrecognized Faces of Critical Illness CytoSorbents Corporation Nasdaq: CTSO Q2 2024 Earnings Conference Call August 13, 2024 Conference Call Participants Moderator: Eric Ribner LifeSci Advisors Christian Steiner, MD Executive VP Sales & Marketing Managing Director CytoSorbents Europe GmbH Christopher Cramer, MS, MBA Senior VP Business Development 2 Phillip Chan, MD, PhD Chief Executive Officer Vincent Capponi, MS President and Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Eft ...

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]

Financial Data and Key Metrics Changes - In Q1 2025, the company reported revenue of $8,700,000, a 3% year-over-year decline, but flat on a constant currency basis compared to $9,000,000 in Q1 2024 [31][34] - Gross margin for the quarter was 71%, consistent with the full year 2024, but lower than 76% in Q1 2024, primarily due to a 23% reduction in units produced [33] - The operating loss improved by 17% to $3,900,000 compared to $4,700,000 in 2024, driven by a 12% reduction in operating expenses [34] Business Line Data and Key Metrics Changes - Core product sales for CytoSorb were $8,700,000 in Q1 2025, representing a 3% year-over-year decline, with strong performances in international distribution offsetting disruptions in the German market [8][10] - The company aims to return German sales to growth in the second half of 2025 after two years of flat performance [10][15] Market Data and Key Metrics Changes - Germany accounts for approximately 40% of the company's sales, and the company is focusing on optimizing its sales strategy in this critical market [15] - The company is also expanding its presence in the Middle East and Africa through its Dubai subsidiary, which is expected to enhance market access [16] Company Strategy and Development Direction - The company is focused on generating new clinical data to guide physicians in optimizing CytoSorb use, which is expected to drive broader adoption and revenue growth [39] - The strategic initiative includes a realignment of the German sales team and approach to improve execution and results [31][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for growth in the second half of 2025, particularly in Germany, despite challenges from hospital reforms and pandemic-related issues [67] - The company is preparing for the potential commercial launch of DrugSorb ATR in the U.S. and Canada, with an initial market opportunity estimated at over $300,000,000 [27][41] Other Important Information - The company successfully executed a shareholder rights offering, raising $6,800,000, which strengthened its balance sheet and increased liquidity [34][36] - The company welcomed a new Vice President of Marketing for North America to lead the strategy for DrugSorb ATR [29] Q&A Session Summary Question: Confidence in FDA appeal and next steps if denied - 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 [47][48] - If the appeal is unsuccessful, the company could pursue a new de novo submission using much of the original data, potentially shortening the review time [49] Question: Impact of clinical data on marketing and reimbursement in Europe - Management confirmed that strong clinical data will be leveraged to support reimbursement and health technology assessments across Europe [53] Question: Updates on European markets beyond Germany - The company is making good progress in major European markets, including the UK, and is seeing momentum in other EU countries [58][60] Question: Focus on other products in development - Currently, the primary focus is on DrugSorb ATR, with other technologies like HemoDefend VGA being considered for future discussions [62] Question: Visibility and confidence in reaccelerating growth in Germany - Management acknowledged the unique challenges in Germany but expressed optimism about the changes being implemented and early positive developments in Q2 [68]

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].

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 ...