SeaStar Medical Holding (ICU) FY Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding - **Ticker Symbol**: ICU (NASDAQ) - **Focus**: Development of QUELIMMUNE Selective Cytopheretic Device for immune-related renal injuries, particularly in critically ill patients facing organ failure [1][2] Core Points and Arguments - **Technology and Approval**: QUELIMMUNE is FDA approved for treating acute kidney injury with sepsis in children under a humanitarian device exemption in 2024 [2][3] - **Market Potential**: - Pediatric AKI market is valued at approximately $100 million with around 4,000 patients in the U.S. - Adult AKI market is significantly larger, with over 200,000 patients annually, representing a market potential of around $4.5 billion [5][18] - **Clinical Studies**: - Pivotal study (NEUTRALIZE-AKI) is currently 60% enrolled, targeting multiple adult indications under breakthrough device designation [4][3] - Clinical data shows a 77% survival rate in pediatric patients treated with QUELIMMUNE, with no patients requiring dialysis after 60 days [12][11] - **Mechanism of Action**: The device targets activated neutrophils and monocytes to quell hyperinflammation without immunosuppression, effectively reducing cytokine storms [8][9][10] Pipeline and Future Indications - **Current Pipeline**: Focus on both pediatric and adult indications, including end-stage renal disease, chronic dialysis, and cardiorenal conditions [4][3] - **Future Studies**: A pivotal randomized controlled study is ongoing for adults, with a primary endpoint of all-cause mortality and dialysis dependency [19][22] Economic Impact and Health Economics - **Cost Savings**: The use of QUELIMMUNE in pediatric patients resulted in a median hospital stay reduction of about 3 days, leading to cost savings for hospitals [16] - **Reimbursement**: The trial has CMS reimbursement, indicating support for the economic viability of the treatment [20] Strategic Focus - **Target Hospitals**: Strategy to focus on the top 50 children's hospitals in the U.S., where 50% of acute kidney injury patients are treated [14] - **Sales and Distribution**: Control over sales and distribution to enhance customer experience and reduce costs [16] Financial Overview - **Market Capitalization**: As of August 12, the stock price was $0.73 with approximately 28 million shares outstanding [23] - **Recent Capital Raise**: Raised around $8.6 million in July 2025 to support ongoing initiatives [24] Conclusion - **Investment Opportunity**: SeaStar Medical presents a best-in-class technology with significant market potential in both pediatric and adult AKI, backed by promising clinical results and a clear strategic focus on commercialization and expansion [25]

Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry for its QUELIMMUNE therapy, showing a 75% survival rate among the first 20 pediatric patients treated for life-threatening Acute Kidney Injury (AKI) and sepsis [1][3] - The therapy is expected to validate or exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine [1][9] - QUELIMMUNE therapy has been adopted by leading children's medical centers in the U.S. and is designed to treat hyperinflammation that leads to organ failure [4][12] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure, with QUELIMMUNE being its first commercial product approved in 2024 [13] - The company has received FDA Breakthrough Device Designation for QUELIMMUNE and five other therapeutic indications, facilitating a faster approval process [13] - The QUELIMMUNE therapy is specifically for pediatric patients with AKI due to sepsis, requiring Renal Replacement Therapy (RRT) [8] Clinical Trials and Data - The SAVE Surveillance Registry is a Real-World Evidence program aimed at confirming the safety and efficacy of QUELIMMUNE, with plans to collect data from up to 300 patients [3] - Additional analyses of preliminary results will be submitted to a pediatric nephrology conference, including 60-day and 90-day survival results [2] - The NEUTRALIZE-AKI pivotal trial is currently evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in adults with AKI [11] Treatment Mechanism - The Selective Cytopheretic Device (SCD) therapy targets overactive immune cells to mitigate destructive hyperinflammation, potentially promoting long-term organ recovery [12] - The therapy integrates with existing CRRT systems to selectively transition pro-inflammatory monocytes to a reparative state [12] Market Impact - The initial results from the SAVE Surveillance Registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [3] - The therapy's success could lead to significant healthcare cost savings by reducing prolonged ICU stays and reliance on dialysis [5]

Core Insights - SeaStar Medical Holding Corporation has expanded its QUELIMMUNE therapy user base by adding a recognized Texas-based children's hospital, which is significant for treating pediatric patients with ultra-rare Acute Kidney Injury (AKI) [1][5] - The QUELIMMUNE therapy was approved by the FDA in 2024 under a Humanitarian Device Exemption to address life-threatening AKI due to sepsis or septic conditions [1][5] - The SAVE Surveillance Registry has been established to monitor safety and outcomes for pediatric patients treated with QUELIMMUNE compared to standard care, with early data analysis expected to be presented at an upcoming medical conference [2][3] Company Developments - SeaStar Medical is making progress in introducing QUELIMMUNE to top children's hospitals in the U.S. and is collecting significant data on its performance through the SAVE Surveillance Registry [3] - The company is conducting the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in adults with AKI, with 119 out of 200 planned subjects enrolled [3][9] - SeaStar Medical has received FDA Breakthrough Device Designation for QUELIMMUNE and five other indications, which may facilitate faster approval and better reimbursement dynamics [11] Clinical Outcomes - Data from clinical studies indicate a 77% survival rate for patients treated with QUELIMMUNE, representing a 50% reduction in loss of life compared to historical data, with 87.5% of survivors achieving normal kidney function by Day 60 post-ICU discharge [7] - The NEUTRALIZE-AKI trial's primary endpoint includes a composite of 90-day mortality or dialysis dependency, with secondary endpoints assessing various health outcomes [9] Industry Context - AKI is characterized by a sudden loss of kidney function and can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The QUELIMMUNE therapy is specifically designed for pediatric patients weighing 10 kilograms or more who are on antibiotics and receiving Renal Replacement Therapy in the ICU [5][10] - SeaStar Medical's SCD therapy aims to modulate the immune response to prevent destructive hyperinflammation, which is critical for improving outcomes in patients with AKI and other related conditions [10]

Core Insights - SeaStar Medical Holding Corporation has introduced QUELIMMUNE therapy at Texas Children's Hospital, which is a potential life-saving treatment for pediatric patients with acute kidney injury (AKI) due to sepsis [1][2] - The QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in loss of life in this patient population [1][4] - The therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which is critical in treating AKI [2][8] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [9] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [9] - The company has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process [9] Clinical Data and Trials - Clinical data published in Kidney Medicine supports the efficacy of QUELIMMUNE, showing no dialysis required for survivors at Day 60 post-ICU discharge [1][6] - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of SCD therapy in adults with AKI [3][7] - The primary endpoint of the NEUTRALIZE-AKI trial includes a composite of 90-day mortality or dialysis dependency [7] Market Impact - The introduction of QUELIMMUNE addresses a significant unmet need for organ-sparing therapies in pediatric patients [2] - The therapy aims to reduce healthcare costs associated with prolonged ICU stays and reliance on dialysis [3] - SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric AKI treatment [6]

Company Overview - Medical Holding Corporation (Nasdaq: ICU) has confirmed compliance with the minimum $2.5 million stockholders' equity requirement for continued listing on The Nasdaq Capital Market, closing the previously disclosed listing matter [1] - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product QUELIMMUNE approved in 2024 for pediatric patients with AKI due to sepsis [9] Product and Therapy Details - QUELIMMUNE therapy is designed for children with AKI and sepsis, showing a 77% survival rate compared to standard care, which represents a 50% reduction in loss of life [4] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize over-active immune cells and mitigate hyperinflammation, with applications in various acute and chronic kidney and cardiovascular diseases [7][8] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SCD therapy in 200 adults with AKI, focusing on 90-day mortality and dialysis dependency as primary endpoints [6] - The trial will also assess secondary endpoints including mortality at 28 days and major adverse kidney events at Day 90 [6] Awards and Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving the lives of pediatric patients with AKI [5]

Core Viewpoint - SeaStar Medical Holding Corporation has undertaken several transactions to ensure compliance with Nasdaq's continued listing standards after receiving a notification regarding non-compliance with market value requirements [2][3]. Group 1: Compliance and Financial Transactions - SeaStar Medical received a notification from Nasdaq on June 24, 2024, indicating non-compliance with the minimum market value requirement of $35 million [2]. - The Nasdaq Hearings Panel granted an extension until June 22, 2025, for the company to demonstrate compliance with an alternative requirement of $2.5 million in stockholders' equity [2]. - The company completed a $4.0 million public offering of common stock and warrants on June 23, 2025, and entered into a purchase agreement with Lincoln Park Capital for up to $15.0 million in common stock purchases over three years [6]. Group 2: Business Operations and Product Development - SeaStar Medical increased its customer count to six for its FDA-approved product, QUELIMMUNE, which reduces pediatric mortality by approximately 50% in patients with multiple organ failure [3][4]. - The company initiated a cost-cutting program in May 2025, expected to reduce operating expenses for the remainder of the fiscal year without materially impacting operations [3]. - Approximately $1.2 million in employee compensation and director fee liabilities were extinguished as certain employees and directors waived their rights to unpaid bonuses and fees [3]. Group 3: Product Overview and Clinical Trials - QUELIMMUNE therapy is designed for children with acute kidney injury (AKI) and sepsis, approved under a Humanitarian Device Exemption in February 2024, and launched commercially in July 2024 [4][10]. - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of the Selective Cytopheretic Device (SCD) therapy in 200 adults with AKI, focusing on 90-day mortality and dialysis dependency as primary endpoints [7]. - The SCD therapy aims to neutralize over-active immune cells and mitigate hyperinflammation, with potential applications in various acute and chronic kidney and cardiovascular diseases [9][10].

Core Insights - SeaStar Medical Holding Corporation is focusing on the commercialization of QUELIMMUNE therapy for critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis [1][2] - The QUELIMMUNE therapy received approval in February 2024 under a Humanitarian Device Exemption, demonstrating safety and probable clinical benefit for a limited population of critically ill children [2] - The therapy aims to reduce destructive hyperinflammation that can lead to organ failure and increased mortality rates [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [4] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [4] - The company has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [6] Therapy Details - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more who are treated in the ICU with Renal Replacement Therapy (RRT) [2] - The therapy was commercially launched in July 2025, following its approval [2] - The therapy addresses the urgent need for effective treatments in pediatric patients with few options available [2][3] Clinical Context - AKI is characterized by a sudden loss of kidney function and can result from various conditions, including sepsis and severe trauma [3] - Destructive hyperinflammation associated with AKI can lead to multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [3] - The company is conducting a pivotal trial of its Selective Cytopheretic Device (SCD) therapy in adult patients with AKI, impacting over 200,000 adults in the U.S. annually [6]

Core Insights - SeaStar Medical Holding Corporation reported a significant four-fold increase in net revenue for QUELIMMUNE therapy, indicating strong customer commitment to improving outcomes for pediatric patients with Acute Kidney Injury (AKI) [2][4] - The company is expanding its technology into the adult AKI market, with the NEUTRALIZE-AKI trial now 50% enrolled, aiming for a Premarket Approval (PMA) application in 2026 [2][3] - SeaStar Medical received two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, enhancing its potential for expedited approval and favorable reimbursement [4][16] Financial Performance - For the first quarter of 2025, net revenue was approximately $0.3 million, a significant increase from $68 thousand in the previous quarter [4][5] - The net loss for the quarter was approximately $3.8 million, or $0.44 per share, a notable improvement compared to a net loss of $12.7 million, or $4.73 per share, in the same period last year [9][27] - Cash and cash equivalents increased to $5.3 million as of March 31, 2025, up from $1.8 million at the end of 2024, following a registered direct offering [10][21] Research and Development - Research and development expenses rose to $2.4 million in Q1 2025 from $1.7 million in Q1 2024, primarily due to increased clinical trial costs for the NEUTRALIZE-AKI trial [6] - General and administrative expenses decreased to approximately $1.7 million in Q1 2025 from $2.3 million in Q1 2024, attributed to lower accounting and legal costs [7] Business Developments - The QUELIMMUNE therapy has been adopted by three new customers, including a nationally recognized children's medical center [4][3] - The NEUTRALIZE-AKI trial is a pivotal study evaluating the SCD therapy's safety and efficacy in adult AKI patients, with results expected to be reported in 2026 [13][16] - SeaStar Medical was awarded the NKF 2025 Corporate Innovator Award for its contributions to improving pediatric AKI treatment [4][16]