Drive adoption of QUELIMMUNE for ultra-rare pediatric AKI, expanding revenue and doubling the customer base Advance SeaStar Medical’s first-in-class SCD therapy for the adult AKI indication – a potential $4.5 billion market – through completion of enrollment of the NEUTRALIZE-AKI pivotal trial and initiation of the PMA process Progress the clinical development of the SCD therapy in patients with severe heart failure Leverage rapid pathways to commercialization of the SCD therapy through additional FDA Human ...

Core Viewpoint - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure, with a significant emphasis on its QUELIMMUNE therapy for acute kidney injury [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to addressing organ failure in critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury due to sepsis in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] Upcoming Events - Eric Schlorff, CEO of SeaStar Medical, will present at the Biotech Showcase 2026 Investor Conference on January 13, 2026 [1] - The live presentation will be accessible on the company's website, with a replay available for 30 days post-event [2] - SeaStar Medical's management will also engage with investors during the J.P. Morgan Healthcare Conference from January 12-14, 2026 [2] Clinical Trials - The company is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [3]

DENVER, Dec. 23, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today the Company’s 1-for-10 reverse stock split (Reverse Split), which will become effective as of 12:01 a.m. Eastern Time on January 5, 2026. The Company’s common stock will begin trading on a post-split adjusted basis on The Nasdaq Capital Market (Nasdaq) ...

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date along with completion of registry expected to expand QUELIMMUNE market opportunity DENVER, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Ad ...

Core Insights - SeaStar Medical Holding Corporation is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at NobleCon21 on December 3, 2025, highlighting its advancements and products [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company with a focus on critically ill patients [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [3] - The company is conducting a pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the U.S. annually [3]

Core Insights - SeaStar Medical Holding Corporation has appointed Michael Messinger as Chief Financial Officer, bringing over 25 years of healthcare industry experience to the company [1][2] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [4] - The company's first commercial product, QUELIMMUNE (SCD-PED) therapy, is FDA approved for life-threatening acute kidney injury (AKI) in critically ill pediatric patients [4] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [4] Leadership and Experience - Michael Messinger has extensive experience in financing and accounting for drug discovery and development organizations, previously serving as CFO of ContraFect Corporation [2] - He has successfully led companies through significant financial milestones, including a Nasdaq IPO and securing a $90 million contract with BARDA [2] Product and Market Potential - The QUELIMMUNE therapy has shown remarkable commercial results in pediatric AKI patients and aims to expand to address multiple indications [3] - SeaStar Medical is conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a condition affecting over 200,000 adults in the U.S. annually [4]

Core Insights - SeaStar Medical Holding Corporation reported strong progress in the third quarter of 2025, highlighting growth in customer base and impressive survival results for its QUELIMMUNE therapy [2][3][4] Business Highlights - Three top-ranked children's medical centers adopted QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) [3][4] - QUELIMMUNE therapy demonstrated a survival rate of 76% at 60 days and 71% at 90 days for 21 pediatric patients, indicating a potential 50% reduction in loss of life compared to historical data [4][14] - The company raised $12.4 million to strengthen its balance sheet and support future operations [5][11] Clinical Trials and Research - The NEUTRALIZE-AKI pivotal clinical trial is ongoing, with an interim analysis showing positive safety signals and no device-related safety issues [4][16] - Total enrollment for the NEUTRALIZE-AKI trial has been adjusted to approximately 339 patients, with 146 patients enrolled to date [4][16] - A new clinical trial for NEUTRALIZE-CRS therapy has been initiated, targeting patients with acute chronic systolic heart failure [4] Financial Performance - Net revenue for the third quarter of 2025 was approximately $0.2 million, compared to $0.1 million in the same period of 2024 [6] - Research and development expenses decreased to $1.9 million from $2.3 million year-over-year, while general and administrative expenses also saw a decline [8][9] - The net loss for the third quarter was approximately $3.5 million, or $0.13 per share, an improvement from a net loss of $4.5 million, or $1.10 per share, in the prior year [11][27] Market Position and Future Outlook - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening pediatric AKI due to sepsis, with significant market potential in both pediatric and adult applications [19] - The company is focused on expanding its market share and generating sales in the adult AKI market, which is significantly larger than the pediatric segment [5][19]

Core Insights - SeaStar Medical Holding Corporation will report its third quarter financial results on November 13, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure [3] - The QUELIMMUNE (SCD-PED) therapy is the company's first commercial product, approved by the FDA in 2024 for life-threatening acute kidney injury (AKI) in pediatric patients [3] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating faster approval and better reimbursement dynamics [3] - A pivotal trial is currently underway for SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), affecting over 200,000 adults annually in the U.S. [3]

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]