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]

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]