SeaStar Medical (NasdaqCM:ICU) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsAnthony Vendetti - Executive Managing Director of ResearchEric Schlorff - CEOJackie Cossmon - ConsultantKevin Chung - Chief Medical OfficerMike Messinger - CFOTim Varacek - SVP of Commercial and Business OperationsConference Call ParticipantsDavid Bautz - Senior AnalystOperatorI would now like to hand the conference over to your speaker today, Jackie Cossmon.Jackie CossmonThank you, Josh. Good afternoon, and ...

SeaStar Medical (NasdaqCM:ICU) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsAnthony Vendetti - Executive Managing Director of ResearchEric Schlorff - CEOJackie Cossmon - ConsultantKevin Chung - Chief Medical OfficerMike Messinger - CFOTim Varacek - SVP of Commercial and Business OperationsConference Call ParticipantsDavid Bautz - Senior AnalystOperatorI would now like to hand the conference over to your speaker today, Jackie Cossmon.Jackie CossmonThank you, Josh. Good afternoon, and ...

Core Insights - SeaStar Medical Holding Corporation has completed enrollment in the SAVE Registry, a Post-Approval Study required by the FDA to confirm the safety of QUELIMMUNE therapy for children with acute kidney injury (AKI) due to sepsis [1][5] - The SAVE Registry has enrolled 50 patients, and the company plans to report 28-day safety results to the FDA after data analysis [1][2] - Early results from the SAVE Registry indicate valuable clinical outcomes data on the safety and probable benefit of QUELIMMUNE therapy [2][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [10] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [10] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications by the FDA, facilitating a faster approval process [10] Product and Technology - QUELIMMUNE therapy is designed for children aged 22 years or younger with AKI due to sepsis, requiring renal replacement therapy [5] - The SCD therapy aims to neutralize over-active immune cells and stop cytokine storms, which can lead to destructive hyperinflammation [9] - Clinical studies have shown a 77% survival rate with QUELIMMUNE therapy, representing a 50% reduction in loss of life compared to historical data [6][7] Clinical Studies and Trials - The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of SCD therapy in 339 adults with AKI in the ICU [8] - The primary endpoint of the NEUTRALIZE-AKI trial is a composite of 90-day mortality or dialysis dependency [8] - Recent data from the SAVE Registry aligns with previous clinical trial results, reinforcing the therapy's effectiveness [7] Market and Adoption - QUELIMMUNE therapy has been adopted by several nationally recognized children's medical centers in the U.S., indicating strong interest and potential for market expansion [2] - The complexities of setting up and running patient registries have previously hindered faster adoption, but the company is optimistic about future growth [2]

Core Insights - SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience of the QUELIMMUNE therapy in Pediatric Nephrology, demonstrating strong survival data and a favorable safety profile [2][3][4] Group 1: Clinical Data and Outcomes - The QUELIMMUNE therapy showed a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 among the first 21 pediatric patients with Acute Kidney Injury (AKI) and sepsis [4] - The therapy is associated with a 50% reduction in patient mortality at 60 days compared to historical data, consistent with results from prior clinical trials [4][10] - Among patients treated with QUELIMMUNE and extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [5] Group 2: Safety Profile - No device-related adverse events or infections were reported in the initial patient cohort, indicating a favorable safety profile for the QUELIMMUNE therapy [4][6] - The absence of immunosuppressive effects further supports the therapy's safety in critically ill pediatric patients [4] Group 3: Regulatory and Research Framework - The SAVE Registry, a post-approval surveillance registry, is designed to collect additional safety and clinical effectiveness data for QUELIMMUNE therapy, initially requiring the enrollment of 300 patients, later reduced to 50 after discussions with the FDA [6][9] - The QUELIMMUNE therapy was approved under a Humanitarian Device Exemption, necessitating participation in the SAVE Registry for real-world data collection [9][14] Group 4: Broader Implications and Adoption - The QUELIMMUNE therapy has been adopted by several nationally recognized children's medical centers in the U.S., indicating growing acceptance and potential for broader application [7] - The therapy aims to address the urgent need for effective treatments for critically ill pediatric patients facing life-threatening conditions due to AKI and sepsis [13][14]

SeaStar Medical (NasdaqCM:ICU) 2026 Conference Summary Company Overview - **Company Name**: SeaStar Medical Holding Corporation - **Ticker Symbol**: ICU - **Industry**: Biotech/Medical Devices - **Mission**: To stop organ failure and save lives through innovative therapies targeting hyperinflammation and acute kidney injury [2][3] Core Points and Arguments Product and Market Potential - **Product**: Quellimune, a selective cytophoretic device (SCD) for treating acute kidney injury (AKI) in pediatric patients [7][10] - **Market Size**: - Pediatric AKI market in the U.S. is approximately $100 million, with about 4,000 children affected annually [3] - Adult AKI market is significantly larger, estimated to be 50 times the pediatric market [3] - **Revenue Potential**: Expected annual revenue of $4-$5 million post-FDA approval for adult indications [3] Clinical Efficacy - **Survival Rates**: Clinical studies show a survival rate increase of 50%-77% for children with AKI treated with Quellimune [10] - **Long-term Outcomes**: Zero patients required long-term dialysis post-treatment, indicating effective kidney recovery [10][11] - **Safety Profile**: No serious adverse events or infections reported, highlighting a clean safety profile [12] Regulatory and Development Strategy - **FDA Designations**: Six breakthrough device designations received, facilitating expedited discussions with the FDA [2][9] - **Current Studies**: - Pivotal study for adult AKI (339 patients) underway, focusing on all-cause mortality and dialysis dependency as endpoints [16][27] - Additional studies for cardiorenal syndrome and bridging to left ventricular assist devices (LVAD) planned [20][21] Commercial Strategy - **Target Hospitals**: Focus on the top 50 children's hospitals in the U.S., aiming to capture 50% of the pediatric AKI market [12][13] - **Customer Growth**: Targeting 20-25 active customers by the end of 2026, up from 10 at the end of 2025 [13][25] - **Cost Savings for Hospitals**: Treatment costs for AKI patients are around $400,000; Quellimune can reduce ICU time and save hospitals between $39,000 and $46,000 per patient [15][28] Financial Health - **Cash Position**: Increased from $47,000 in 2022 to over $13 million as of September 30, 2025 [24] - **Market Capitalization**: Approximately $9 million, trading at or below cash value [25] - **Sales Projections**: Anticipated sales of $1 million for Quellimune by the end of 2025 [25] Additional Insights - **Organ Agnostic Approach**: The therapy targets neutrophils and monocytes, which function across various organs, indicating potential for broader applications beyond AKI [22] - **Educational Efforts**: Significant investment in medical affairs and education to promote understanding and adoption of the therapy [23] - **Reimbursement Strategy**: No reimbursement code required for pediatric use; reimbursement for adult patients is anticipated through CMS [29] This summary encapsulates the key points from the SeaStar Medical conference, highlighting the company's innovative approach to treating acute kidney injury and its strategic plans for growth and market penetration.

Core Insights - The FDA has approved a reduction in the mandatory enrollment size for the SAVE Surveillance Registry from 300 patients to 50 patients, indicating confidence in the safety of the QUELIMMUNE therapy with fewer patients [1] - The QUELIMMUNE therapy, designed for pediatric patients with acute kidney injury (AKI) and sepsis, has shown promising efficacy data, including a survival rate improvement from 50% to 70% at 90 days [3][8] - The reduction in registry size is expected to facilitate smoother adoption of QUELIMMUNE therapy, potentially expanding its market opportunity in the pediatric AKI sector, estimated at $100 million in the U.S. [4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved in 2024 [12] - The QUELIMMUNE therapy utilizes the Selective Cytopheretic Device (SCD) to address hyperinflammation in patients, aiming to improve survival rates and reduce the need for dialysis [11] - The company has received recognition for its contributions to pediatric AKI treatment, including the 2025 Corporate Innovator Award from the National Kidney Foundation [9] Clinical Data - Preliminary results from the SAVE Surveillance Registry indicate zero device-related adverse events and a survival rate of 76% at Day 28 and Day 60, with a 71% survival rate at Day 90 [3][8] - Data from clinical studies show a 77% survival rate for patients treated with QUELIMMUNE compared to standard care, reflecting a 50% reduction in loss of life compared to historical data [8] - The SAVE Surveillance Registry has enrolled 32 pediatric patients to date, with the aim of confirming the safety of QUELIMMUNE therapy [2] Market Potential - The approval of QUELIMMUNE therapy is expected to enhance treatment options for pediatric patients with AKI, a condition that can lead to severe complications and increased healthcare costs [5][6] - The reduction in patient enrollment requirements is anticipated to accelerate the adoption of QUELIMMUNE therapy in medical institutions, thereby capturing a larger share of the pediatric AKI market [4]

Core Insights - The independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial for the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) [2][3] - The trial's sample size has been re-estimated from 200 to 339 patients to strengthen statistical power, with 137 patients currently enrolled [3][4] - The SCD therapy has shown no device-related safety issues and a potential clinical benefit, as indicated by preliminary results from the QUELIMMUNE SAVE pediatric registry [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on treatments for critically ill patients facing organ failure [10] - The QUELIMMUNE therapy, based on the SCD technology, is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [10] - The company aims to drive shareholder value through successful execution of commercial efforts and completion of the NEUTRALIZE-AKI trial [4][10] Clinical Trial Details - The NEUTRALIZE-AKI trial's primary endpoint is a composite of 90-day mortality or dialysis dependency in patients treated with SCD therapy alongside standard care [3][10] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [3] - The trial will also explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome [3] Safety and Efficacy - The SCD therapy has been associated with zero device-related adverse events, consistent with its previously published safety profile [6] - Preliminary data from the SAVE Surveillance Registry indicates a potential reduction in loss of life by over 50% compared to historical data [7][5] - The therapy aims to neutralize over-active immune cells and mitigate destructive hyperinflammation, potentially leading to long-term organ recovery [9]

Core Insights - SeaStar Medical Holding Corporation announced preliminary results from the SAVE Surveillance Registry, focusing on QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] - The SAVE Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with data collection for the first 300 patients treated [2] - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more, approved under a Humanitarian Device Exemption [4][10] Group 1: SAVE Surveillance Registry - The SAVE Surveillance Registry is a Real-World Evidence program to validate QUELIMMUNE therapy's safety and efficacy [2] - Specific outcomes measured will include 90-day survival rates and dialysis dependency, with comparisons to a control group [2] - Initial results are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [2] Group 2: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, often caused by conditions like sepsis and severe trauma [3] - Destructive hyperinflammation in AKI can lead to multi-organ dysfunction and increased mortality risk [3] - Patients recovering from AKI may face complications such as chronic kidney disease or end-stage renal disease [3] Group 3: QUELIMMUNE Therapy - QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in mortality [5] - Among survivors, 87.5% had normal kidney function by Day 60 post-ICU discharge [5] - The therapy is integrated with existing CRRT systems to target pro-inflammatory cells and promote organ recovery [9] Group 4: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure [10] - QUELIMMUNE is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [10] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI, addressing a significant unmet medical need [10]

As filed with the Securities and Exchange Commission on August 8, 2025 Registration No. 333- (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) 3513 Brigh ...

Core Points - SeaStar Medical has successfully enrolled 125 out of 200 anticipated patients in the NEUTRALIZE-AKI pivotal clinical trial, achieving over 60% enrollment [1][4] - The company has activated a new clinical trial site at Methodist Hospital Metropolitan in San Antonio, Texas, bringing the total to 16 sites [1][3] - An interim analysis of the first 100 patients is expected in the third quarter of 2025, conducted by the independent Data Safety Monitoring Review Board (DSMB) [2][4] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [10] - The company's Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation from the FDA for six indications, including treatment for adult AKI requiring continuous renal replacement therapy (CRRT) [8][10] - SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 for treating life-threatening acute kidney injury (AKI) in critically ill pediatric patients [10] Clinical Trial Details - The NEUTRALIZE-AKI trial aims to enroll up to 200 adult patients with AKI requiring CRRT, with a primary endpoint of 90-day mortality or dialysis dependency [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The trial's interim analysis will assess the primary endpoint when approximately 50% of patients have completed the 90-day follow-up [5] Technology and Treatment - The SCD therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which can lead to multi-organ dysfunction [9] - This therapy is integrated with existing CRRT systems to selectively target proinflammatory monocytes and promote a reparative state [9] - The SCD therapy has potential applications in multiple acute and chronic kidney and cardiovascular diseases, addressing a significant unmet medical need [9]