Core Insights - SeaStar Medical Holding Corporation presented new data from the SAVE Registry, indicating no device-related adverse events or immunosuppression, alongside strong survival rates for pediatric patients with Acute Kidney Injury (AKI) [1][9] - The Selective Cytopheretic Device (SCD) therapy shows potential in modulating the immune response, shifting monocytes towards an anti-inflammatory phenotype, which may improve treatment outcomes for critically ill pediatric patients [1][5] Company Developments - SeaStar Medical hosted an educational symposium featuring leading experts discussing pediatric AKI, the QUELIMMUNE SAVE Registry, and the immunomodulatory effects of the SCD therapy [3][6] - The QUELIMMUNE therapy, approved in February 2024, is designed for critically ill pediatric patients with life-threatening AKI and sepsis requiring Renal Replacement Therapy (RRT) [6][15] Clinical Data - Presentations at the conference highlighted an 18-month post-approval clinical experience from the SAVE Registry, showing survival rates of 69% at Day 28 and Day 60 for patients treated with QUELIMMUNE [4] - Data from the SAVE Registry indicated a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90, demonstrating a 50% reduction in mortality compared to historical data [9][7] Research Insights - In vitro studies demonstrated that the SCD therapy induces monocyte phenotype switching towards an anti-inflammatory and reparative state, which may help in managing hyperinflammatory conditions associated with AKI [5][10] - The SCD therapy is integrated with existing continuous renal replacement therapy (CRRT) systems, targeting pro-inflammatory monocytes to promote organ recovery and potentially eliminate the need for future dialysis [14] Industry Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving pediatric AKI treatment through the QUELIMMUNE therapy [8]

Core Insights - SeaStar Medical Holding Corporation has expanded its QUELIMMUNE™ pediatric Acute Kidney Injury (AKI) customer base and completed key clinical trial milestones, indicating strong momentum in its business operations [1][2][3] Business Updates - The company has added 13 new customers from top-ranked children's hospitals, increasing its total customer base to 16 [3] - Enrollment in the FDA-mandated QUELIMMUNE SAVE Post-Marketing Registry has been completed with 50 patients enrolled [3] - The pivotal NEUTRALIZE-AKI trial for adult patients with AKI has surpassed the 50% enrollment milestone, with 181 out of 339 patients enrolled [3] - A cardio-renal clinical trial has been initiated to further advance the company's pipeline [1][2] Financial Performance - For the three months ended December 31, 2025, net revenue was approximately $420 thousand, a significant increase from $67 thousand in the same period in 2024, driven by product sales to an expanding customer base [5] - The cost of goods sold for the same period was $12 thousand, resulting in a gross margin greater than 90% [6] - Research and development expenses decreased to $2.2 million from $2.7 million year-over-year, primarily due to reduced consulting and personnel costs [7] - General and administrative expenses also decreased to approximately $1.2 million from $2.1 million, reflecting lower personnel and consulting costs [9] - The net loss for the three months ended December 31, 2025, was approximately $2.9 million, or $0.80 per share, compared to a net loss of approximately $4.4 million, or $8.98 per share, in the same period in 2024 [11] Future Outlook - The company anticipates achieving approximately $2 million in net product revenue in 2026 [8] - Plans to submit a modular Premarket Application (PMA) to expedite the FDA review process for the SCD therapy are underway [8] - The NEUTRALIZE-AKI pivotal trial is expected to complete enrollment by the end of 2026 [8] - The company aims to explore additional regulatory pathways for the SCD therapy to facilitate rapid commercialization [8]

Company Overview - SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [3] - The company's first commercial product, QUELIMMUNE (SCD-PED), was approved by the FDA in 2024 and is the only FDA-approved product for life-threatening Acute Kidney Injury (AKI) due to sepsis in critically ill pediatric patients [3] - SeaStar Medical's 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 [3] Clinical Trials and Market Potential - The company is currently conducting the NEUTRALIZE-AKI pivotal clinical 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 with no effective treatment options [3] Upcoming Financial Reporting - SeaStar Medical will report its fourth quarter and year-end 2025 financial results after market close on March 25, 2026, and will host a webcast and conference call to discuss these results and business progress [1][2]

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 is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life [1][3] - The company will present at Noble Capital Markets' Emerging Growth Virtual Equity Conference on February 5, 2026 [1] - SeaStar Medical's QUELIMMUNE (SCD-PED) therapy is the first commercial product based on its patented Selective Cytopheretic Device (SCD) technology, approved by the FDA in 2024 [3] Company Overview - SeaStar Medical is a commercial-stage healthcare company targeting critically ill patients with organ failure [3] - The QUELIMMUNE (SCD-PED) therapy is the only FDA-approved treatment for life-threatening acute kidney injury (AKI) due to sepsis 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] Clinical Trials - The company is conducting the NEUTRALIZE-AKI pivotal trial for its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT) [3] - This condition affects over 200,000 adults in the U.S. annually and currently has no effective treatment options [3]

Core Insights - SeaStar Medical is focused on expanding the adoption of its QUELIMMUNE therapy for ultra-rare pediatric acute kidney injury (AKI) and advancing its Selective Cytopheretic Device (SCD) therapy for adult AKI, targeting a potential market of $4.5 billion [1][2] Group 1: QUELIMMUNE Therapy - The QUELIMMUNE therapy is designed for children with AKI and sepsis, approved under a Humanitarian Device Exemption, requiring participation in the SAVE Surveillance Registry [3] - Clinical studies show a 77% survival rate for patients treated with QUELIMMUNE, indicating a 50% reduction in loss of life compared to historical data [4] - The customer base for QUELIMMUNE has expanded to 10 top-rated children's hospitals, with expectations of achieving approximately $2 million in net product revenue in 2026 [8] Group 2: SCD Therapy Development - The SCD therapy is being advanced for adult AKI through the NEUTRALIZE-AKI pivotal trial, with enrollment completion expected by the end of 2026 [2][6] - The FDA has granted Breakthrough Device Designation for the SCD therapy in both adult AKI and acute chronic heart failure (CHF) with cardiorenal syndrome, facilitating a faster approval process [2][10] - The company is exploring broader applications of the SCD therapy, including its use in patients with CHF awaiting left ventricular assist device (LVAD) implantation [2][10] Group 3: Market Opportunities - The potential market for the SCD therapy in adult patients with AKI and CHF is described as a multi-billion-dollar opportunity in the U.S. alone [2] - The company aims to leverage rapid regulatory pathways to commercialize the SCD therapy across various hyperinflammatory conditions [2][10] - The successful outcome of the NEUTRALIZE-AKI trial could lead to a Premarket Approval application in 2027, with expectations for rapid approval and early adoption [2]

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]

Core Viewpoint - SeaStar Medical Holding Corporation announced a 1-for-10 reverse stock split effective January 5, 2026, to increase its stock price and regain compliance with Nasdaq's minimum bid price requirement of $1.00 [1][4]. Group 1: Reverse Stock Split Details - The reverse stock split will convert every 10 pre-split shares into 1 post-split share, with stockholders receiving whole shares in lieu of any fractional shares [2]. - The reverse split will proportionately reduce the number of shares issuable upon the exercise of outstanding stock options and warrants, while also increasing their exercise prices accordingly [2]. Group 2: Stockholder Information - Stockholders will receive information regarding their share ownership from Continental Stock Transfer and Trust Company following the reverse stock split [3]. - Those holding shares through banks or brokers will have their positions automatically adjusted without needing further action [3]. Group 3: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE (SCD-PED) therapy, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [5]. - The company is conducting the NEUTRALIZE-AKI pivotal trial for its SCD therapy in adult patients, addressing a significant unmet medical need affecting over 200,000 adults in the U.S. annually [5].

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 - 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]