Fourth quarter and Full-Year 2025 revenue are expected to be approximately $9.2 million and $37.0 million, respectively, with expected Q4 gross margins in the range of 73% to 75% DrugSorb®-ATR De Novo Pre-Submission Meeting scheduled with the FDA this month, with anticipated De Novo Application filing this quarter and regulatory decision in mid-2026 Results of the pivotal STAR-T study for DrugSorb®-ATR have recently been accepted for publication in a top cardiac surgery journal Management will host in-perso ...

Company Overview - CytoSorbents has made significant progress with two key products: CytoSorb, which removes harmful cytokines from the blood, and DrugSorb, which is designed to eliminate drugs, particularly blood thinners [2]. Industry Context - The biotechnology sector, particularly microcap companies like CytoSorbents, faces challenges due to the evolving regulatory landscape and the nascent nature of the science and technology involved [3]. Future Outlook - The company is preparing for key upcoming events that are crucial for investors to monitor, indicating a proactive approach to navigating the complexities of the biotechnology industry [3].

Summary of CytoSorbents Fireside Chat - December 15, 2025 Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Biotechnology, specifically medical devices focused on blood purification - **Key Products**: - **CytoSorb**: Removes cytokines and toxic substances from blood - **DrugSorb-ATR**: Investigational product aimed at removing blood thinners Core Points and Arguments - **Product Mechanism**: CytoSorb utilizes a highly porous polymer bead technology to extract toxic materials from blood without the need for affinity agents, making it compatible with existing hospital blood pumps [6][7] - **Market Presence**: CytoSorb is EU-approved and sold in over 70 countries, with more than 300,000 human treatments conducted to date, generating approximately $37 million in trailing 12-month revenue [9][10] - **Gross Margins**: The product has a gross margin of about 71%, with potential for higher margins as the U.S. market is pursued [10] - **Regulatory Strategy**: The company is focusing on the U.S. market for DrugSorb, which has received two FDA breakthrough device designations due to the significant unmet medical need for managing perioperative bleeding in patients on blood thinners [11][22] - **Clinical Trials**: The START trial, a randomized controlled trial involving 140 patients, aimed to demonstrate the efficacy of DrugSorb in reducing perioperative bleeding but missed its primary endpoint due to trial design issues [41][51] - **Regulatory Discussions**: The FDA has acknowledged the safety of the device and is open to a new De Novo submission that includes real-world evidence to support efficacy [58][62] Financial Management - **Cash Flow Strategy**: The company aims to achieve cash flow break-even by early 2026, with a refinancing agreement providing additional cash and extending the interest-only period on debt [70][71] - **Market Opportunity**: The total addressable market for DrugSorb is estimated at $300 million, potentially growing to over $1 billion as additional blood thinners and surgeries are included [26] Pipeline and Future Prospects - **Product Pipeline**: In addition to CytoSorb and DrugSorb, the company has products like VetRescue for animals and HemoDefend-BGA for universal plasma, indicating a broadening of its product offerings [12][13] - **Launch Strategy**: Upon FDA approval, the company plans a targeted launch in the U.S., focusing on clinical sites that have shown interest in the product [73][74] - **Regulatory Outlook**: The company expects to submit a new De Novo application in early 2026, with the potential for approval within the same year [64][65] Additional Insights - **Market Challenges**: The company faces challenges typical of microcap biotech firms, including the need for substantial resources for clinical trials and regulatory approvals [51][52] - **Surgeon Interest**: There is significant interest from surgeons in the U.S. for a solution to manage bleeding risks associated with blood thinners during surgeries, which could facilitate a successful product launch [74] This summary encapsulates the key points discussed during the fireside chat, highlighting the company's current status, regulatory strategies, financial management, and future prospects in the biotechnology industry.

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]

Summary of CytoSorbents Conference Call Company Overview - **Company**: CytoSorbents (NasdaqCM:CTSO) - **Industry**: Medical Technology, specifically blood purification - **Core Product**: CytoSorb, a blood purification technology designed to remove toxins and harmful substances from blood, particularly in critical care settings and cardiac surgery [2][3] Key Points and Arguments Financial Performance - **Core Product Sales**: CytoSorb achieved record sales of $37 million over the trailing twelve months with a gross margin of 71% [3] - **Recent Revenue**: Third quarter revenue was $9.5 million, a 10% increase from $8.6 million year-over-year, driven by strong sales in distributor territories and favorable currency exchange rates [20] - **Cash Position**: As of the end of the third quarter, the company had $9.1 million in cash, with an amended credit agreement providing an additional $2.5 million and extending the interest-only period to January 2027 [20][39] Product Development and Regulatory Path - **DrugSorb ATR**: An investigational device aimed at reducing bleeding severity in patients on blood thinners undergoing CABG surgery, with FDA breakthrough device designation [3][11] - **Regulatory Timeline**: A new de novo submission is expected in 2026, with a regulatory decision anticipated mid-2026 following a 150-day review process [17][18] - **FDA Collaboration**: The company has had positive discussions with the FDA, addressing previous submission issues and focusing on new efficacy data [25][26] Market Opportunities - **Critical Care Market**: CytoSorb targets severe inflammation in critical care, impacting up to 60% of ICU patients, with applications in conditions like sepsis, burn injury, and acute respiratory distress syndrome [7][8][10] - **Sepsis Treatment**: Sepsis accounts for roughly half of CytoSorb's treatments, representing a significant market opportunity as it is a leading cause of death worldwide [10][42] - **Blood Thinner Market**: DrugSorb ATR addresses a $1 billion total addressable market in the U.S. for patients on blood thinners, particularly during urgent surgeries [11][12] Competitive Landscape - **Industry Positioning**: CytoSorbents aims to differentiate itself from competitors focused on chronic kidney disease, which typically impacts only 10-15% of ICU patients, compared to the broader critical care market [9] Future Growth Strategy - **Sales Strategy**: The company plans a controlled market release for DrugSorb ATR, focusing on clinical accounts and gradually expanding its sales force based on adoption rates [28][32] - **Expansion Plans**: There are intentions to target additional blood thinners and expand applications beyond cardiac surgery [36][37] Additional Important Information - **Technological Advantage**: CytoSorb's technology is described as having a significantly larger surface area for toxin removal compared to traditional dialysis, enhancing its effectiveness in critical care [5][6] - **Clinical Data**: The company has a robust body of clinical data supporting its technology, with hundreds of publications in various applications [9] Conclusion - CytoSorbents is positioned for growth with a strong product offering in the critical care market, a solid financial foundation, and a clear regulatory pathway for its investigational device. The company aims to achieve cash flow breakeven by Q1 2026 while addressing significant unmet medical needs in sepsis and surgical bleeding management [4][22][40]

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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]

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Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $9.5 million, an increase of 10% from $8.6 million in Q3 2024, or 4% on a constant currency basis [5][11] - Gross margin improved to approximately 70% compared to 61% in Q3 2024 [5][11] - Adjusted net loss for the quarter improved to $2.6 million, or $0.04 per share, compared to an adjusted net loss of $4.5 million, or $0.08 per share in the prior year [14] Business Line Data and Key Metrics Changes - Core product sales reached a record $37 million for the trailing 12 months as of September 30, 2025, up from $33.8 million a year ago [4][6] - Distributor and partner sales grew 14% to $15.6 million, while direct sales outside Germany rose approximately 24% to $8.8 million [6] - Sales in Germany declined modestly by 3% to $12.6 million [6] Market Data and Key Metrics Changes - CytoSorb is approved in the European Union and available in over 70 countries, with nearly 300,000 treatments performed to date [4] - The U.S. market opportunity for DrugSorb ATR is initially estimated at $300 million, potentially exceeding $1 billion as Brilinta becomes generic [9] Company Strategy and Development Direction - The company focuses on five key initiatives: returning to higher growth in CytoSorb, obtaining U.S. marketing approval for DrugSorb ATR, achieving near-term cash flow break-even, strengthening the balance sheet, and maximizing shareholder value [5][19] - A strategic workforce and cost reduction program has been implemented, including a workforce reduction of approximately 10% [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow break-even beginning in Q1 2026, supported by improvements in operating margins and cash burn [15][18] - The company anticipates a mid-2026 regulatory decision for DrugSorb ATR following a new De Novo filing in Q1 2026 [10] Other Important Information - The company amended its loan agreement with Avenue Capital Group, providing immediate funding of $2.5 million and extending the interest-only period to December 31, 2026 [17] - The company recognizes the need for improved performance in Germany and is restructuring its sales team and approach [6][7] Q&A Session Summary Question: What is the expected gross margin for Q4 and 2026? - Management is pleased with the current 70% gross margin and sees opportunities for improvement as efficiencies increase and volumes rise [23] Question: Are there any milestones for the German sales force restructuring? - Management indicated it is too early to assess the full impact but noted improvements in representative performance and efficiency [24] Question: What is the difference between the pre-submission package and the full application for the FDA? - The pre-submission package aims to align with FDA concerns and guidance, ensuring no surprises in the final De Novo submission [25][26] Question: Feedback from the World Sepsis Day webcast? - The response has been excellent, highlighting the broad applications of CytoSorb in treating sepsis and septic shock [27][29]

Financial Performance - Third quarter 2025 revenue was $9.5 million, representing a 10% year-over-year increase from $8.6 million in Q3 2024[5] - Gross margin improved to 70% in Q3 2025, up from 61% in Q3 2024, due to resolved manufacturing issues and improved operational efficiencies[5] - Operating loss decreased to $2.9 million in Q3 2025, compared to $4.8 million in Q3 2024, driven by better gross margins and lower operating expenses[5] - Adjusted net loss improved to $2.6 million or $0.04 per share, compared to an adjusted net loss of $4.5 million or $0.08 per share in Q3 2024[5] - CytoSorbents reported revenue of $9.485 million for Q3 2025, a 10.1% increase from $8.613 million in Q3 2024[28] - Gross profit for Q3 2025 was $6.666 million, compared to $5.256 million in Q3 2024, reflecting a gross margin improvement[28] - The company incurred a net loss of $3.170 million in Q3 2025, compared to a net loss of $2.768 million in Q3 2024[28] - For the nine months ended September 30, 2025, the net loss was $2,701,000, a significant improvement compared to a net loss of $13,152,000 for the same period in 2024[30] - The company reported stock-based compensation of $1,879,000 for the nine months ended September 30, 2025, down from $2,840,000 in the same period of 2024[30] - The adjusted EBITDA for the nine months ended September 30, 2025, was $(7,348,000), an improvement from $(9,036,000) in the same period of 2024[31] - The basic net loss per common share for the three months ended September 30, 2025, was $(0.05), consistent with the same period in 2024[31] Cash Flow and Assets - The company expects to reach cash flow breakeven in Q1 2026 following a workforce reduction of approximately 10% and a cost reduction program[7] - Proforma cash, cash equivalents, and restricted cash was $11.6 million on September 30, 2025, assuming the additional term loan was drawn[6] - Cash and cash equivalents increased to $7.536 million as of September 30, 2025, up from $3.280 million at the end of 2024[27] - Cash, cash equivalents, and restricted cash at the end of the period were $9,058,000, compared to $12,168,000 at the end of September 30, 2024[30] - The net cash used in operating activities for the nine months ended September 30, 2025, was $7,552,000, compared to $12,087,000 for the same period in 2024[30] Liabilities and Equity - Total current assets decreased slightly to $21.313 million as of September 30, 2025, from $21.604 million as of December 31, 2024[27] - Total liabilities increased to $36.730 million as of September 30, 2025, compared to $36.265 million at the end of 2024[27] - The total stockholders' equity as of September 30, 2025, was $9,020,000, a decrease from $11,586,000 as of June 30, 2025[29] Regulatory and Product Development - The company submitted a De Novo pre-submission package for DrugSorb™-ATR to the FDA, with a regulatory decision anticipated by mid-2026[5][11] - CytoSorbents is actively pursuing regulatory approval for the DrugSorb™-ATR system with the U.S. FDA and Health Canada[20] - The company has multiple products under development, including ECOS-300CY®, CytoSorb-XL™, and DrugSorb™, protected by numerous patents[21] Clinical Programs and Research - Recent clinical data publications reinforce the effectiveness of CytoSorbents' therapies in managing sepsis and septic shock, highlighting significant reductions in mortality rates[14] - The company plans to expand clinical programs across all applications to improve patient outcomes and support healthcare workers globally[15] Financing and Credit - An amended credit agreement with Avenue Capital Group provides an additional $2.5 million in term loan capital and extends the interest-only period to December 31, 2026[8] - The company reported proceeds from the exercise of common stock warrants amounting to $1,439,000 for the nine months ended September 30, 2025[30] - The company incurred foreign currency transaction gains of $9,128,000 for the nine months ended September 30, 2025, compared to gains of $680,000 in the same period of 2024[30]