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]

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, is based on its patented Selective Cytopheretic Device (SCD) technology and was approved by the FDA in 2024 [3] - QUELIMMUNE is the only FDA-approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [3] Product and Technology - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for six therapeutic indications from the FDA, which may facilitate a faster approval process and better reimbursement dynamics [3] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a condition affecting over 200,000 adults in the US annually [3] Upcoming Events - SeaStar Medical will participate in the HC Wainwright 27th Annual Global Investment Conference, with a presentation scheduled for September 5, 2025, at 7:00 am Eastern Time [1][2]

Core Insights - SeaStar Medical Holding Corporation has published a health economic analysis indicating that the QUELIMMUNE therapy can save approximately $69,146 per hospitalization for pediatric patients with Acute Kidney Injury (AKI) in the ICU compared to standard continuous renal replacement therapy (CRRT) [1][4] - The QUELIMMUNE therapy has shown a 77% survival rate in treated patients, representing a potential ~50% reduction in loss of life compared to historical data [3][8] - The therapy is currently being adopted by leading children's medical centers, which may enhance its broader acceptance in the healthcare market [2] Economic Impact - The analysis estimates that the QUELIMMUNE therapy could offset its own costs, potentially leading to no out-of-pocket expenses for institutions for a median treatment duration of 6 days [1][4] - Modeled hospitalization costs for pediatric patients treated with QUELIMMUNE are estimated at $320,304, significantly lower than $457,092 and $389,451 for patients in the KID and ppCRRT cohorts respectively [4] Clinical Efficacy - QUELIMMUNE therapy has received FDA approval under a Humanitarian Device Exemption for pediatric patients with AKI due to sepsis, showing no dialysis required for survivors at Day 60 post-treatment [3][7] - A pivotal trial, NEUTRALIZE-AKI, is underway to evaluate the safety and efficacy of the SCD therapy in adults with AKI, which has received FDA Breakthrough Device Designation [4][10] Technology Overview - The QUELIMMUNE therapy utilizes patented Selective Cytopheretic Device (SCD) technology aimed at modulating the immune response to prevent destructive hyperinflammation in critically ill patients [11][14] - This therapy is the only FDA-approved option for treating life-threatening AKI due to sepsis in critically ill pediatric patients, addressing a significant unmet medical need [14]

Core Insights - SeaStar Medical Holding Corporation reported significant progress in its clinical trials and business initiatives, including patient enrollment and new customer acquisitions for its QUELIMMUNE therapy [2][3][4]. Financial Performance - For the three months ended June 30, 2025, net revenue was approximately $0.3 million, primarily from sales of QUELIMMUNE therapy [5]. - Research and development expenses decreased to $1.0 million from $2.3 million in the same period of 2024, driven by reduced clinical trial costs [6]. - General and administrative expenses also fell to approximately $1.0 million from $2.3 million year-over-year, reflecting cost-saving measures [7]. - The net loss for the quarter was approximately $2.0 million, or $0.18 per share, an improvement from a net loss of $3.2 million, or $1.03 per share, in the same quarter of 2024 [9]. Clinical Developments - The NEUTRALIZE-AKI trial has enrolled over 60% of its target, with 125 out of 200 patients now enrolled, and interim analysis results are expected in Q3 2025 [4][17]. - Three new top-rated children's hospitals have adopted the QUELIMMUNE therapy, expanding its customer base [3][4]. - Positive survival results from the SAVE Surveillance Registry indicated a 75% survival rate for the first 20 pediatric patients treated with QUELIMMUNE, with no device-related safety events reported [4][15]. Funding and Financial Position - Cash at June 30, 2025, was $6.3 million, a significant increase from $1.8 million at the end of 2024, bolstered by $8.4 million raised in two registered direct offerings [10][12]. - The company implemented additional cost-saving measures to extend its financial runway and focus resources on developing SCD therapy for adult patients with AKI, which represents a much larger market opportunity compared to pediatric AKI [12]. Regulatory and Research Initiatives - The U.S. Centers for Medicare & Medicaid Services (CMS) agreed to cover certain expenses for patients enrolled in the NEUTRALIZE-CRS trial, a rare achievement for clinical trials [4]. - A $2 million grant from the U.S. Department of Defense was awarded to support research on the application of SCD therapy in severe burn cases, highlighting the therapy's potential in diverse medical scenarios [4].

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]

Core Points - SeaStar Medical Holding Corporation has entered into a definitive agreement for the issuance and sale of 4,960,544 shares of common stock at a price of $0.887 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.762 [1][2] - The gross proceeds from this offering are expected to be approximately $4.4 million, which will be used for general corporate purposes, including working capital and capital expenditures [2] - The offering is being conducted under a shelf registration statement previously filed with the SEC, and the shares are being offered only by means of a prospectus [3] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [6] - The company’s Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation from the FDA for six therapeutic indications, which may facilitate faster approval and better reimbursement dynamics [6] - SeaStar Medical is currently conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6]

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 Viewpoint - SeaStar Medical Holding Corporation has announced a definitive agreement for the issuance and sale of 5,242,464 shares of common stock at a price of $0.763 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.638, aiming to raise approximately $4 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement for unregistered warrants [1][2]. - The gross proceeds from the offering are expected to be around $4 million, with net proceeds intended for general corporate purposes, including working capital and capital expenditures [2]. Group 2: Regulatory and Compliance Information - The shares are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The unregistered warrants are not registered under the Securities Act and cannot be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [6]. - The company’s Selective Cytopheretic Device therapy has received Breakthrough Device Designation for six therapeutic indications, indicating a potential for expedited approval processes [6]. - SeaStar is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6].