Core Insights - SeaStar Medical Holding Corporation has made significant progress in 2024, including the approval and commercial launch of its QUELIMMUNE therapy, and is positioned for a transformational year in 2025 [2][3] Business Highlights - The FDA granted approval for QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) due to sepsis, impacting approximately 4,000 pediatric patients annually [3] - QUELIMMUNE therapy has been adopted by five customers, with a growing pipeline of prospective customers [3] - The NEUTRALIZE AKI pivotal trial has enrolled 94 out of the anticipated 200 patients, with participation from prestigious medical centers [3][12] - SeaStar Medical received its fourth Breakthrough Device Designation for the Selective Cytopheretic Device (SCD) therapy, aimed at treating chronic systemic inflammation in end-stage renal disease patients [3] - The National Institutes of Health awarded a $3.6 million grant for a clinical trial evaluating SCD therapy as a bridging strategy for patients with chronic heart failure [3] - The company was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric patients with AKI [3] Financial Performance - For the year ended December 31, 2024, net revenue was $0.1 million, a significant increase from no revenue in 2023, attributed to the initiation of QUELIMMUNE sales [5] - Research and development expenses rose to approximately $9.1 million in 2024 from $6.0 million in 2023, driven by clinical trial expenses and increased personnel costs [6] - General and administrative expenses increased to $8.9 million in 2024 from $8.2 million in 2023, primarily due to higher headcount and legal expenses [7] - The net loss for the year was $24.8 million, an improvement from a net loss of $26.2 million in 2023, with a net loss per share of $6.63 compared to $30.26 in the previous year [9][23] Balance Sheet Improvements - The company improved its balance sheet by adding approximately $31 million in capital and reducing debt and liabilities [4] - Cash and cash equivalents at December 31, 2024, were $1.8 million, reflecting a significant increase from $176,000 at the end of 2023 [20]

Core Insights - SeaStar Medical Holding Corporation is set to report its fourth quarter and year-end 2024 financial results on March 27, 2025, after market close [1] - The company focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product, QUELIMMUNE, approved by the FDA in 2024 [2] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to critically ill patients with organ failure and potential loss of life [2] - QUELIMMUNE (SCD-PED) is the only FDA-approved product for life-threatening acute kidney injury (AKI) due to sepsis in critically ill pediatric patients [2] - The Selective Cytopheretic Device (SCD) therapy has received Breakthrough Device Designation for four therapeutic indications, facilitating a faster approval process and better reimbursement dynamics [2] - The company 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 [2]

Company Overview - SeaStar Medical has been awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric acute kidney injury (AKI) treatment [1][4] - The company's QUELIMMUNE Selective Cytopheretic Device for Pediatrics (SCD-PED) is the first and only FDA-approved therapeutic device for treating pediatric AKI due to sepsis [2][9] - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with its first commercial product approved in 2024 [9] Industry Context - Approximately 4,000 children in the U.S. with AKI, primarily due to sepsis, require continuous kidney replacement therapy (KRT) annually, with a mortality rate of around 50% [3] - The standard of care for AKI has not changed significantly over the past decades, leading to stagnant patient outcomes [3] - AKI can lead to severe complications, including chronic kidney disease and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [6] Recognition and Impact - The Corporate Innovator Award recognizes companies that address unmet medical needs in nephrology, with past recipients including major pharmaceutical companies [4] - SeaStar Medical's QUELIMMUNE device has been noted for its role in saving children's lives and preventing long-term dialysis [4] - The National Kidney Foundation emphasizes the importance of innovation in improving patient outcomes in kidney care [11]

Core Viewpoint - SeaStar Medical Holding Corporation has successfully closed a registered direct offering, raising approximately $6 million through the issuance of 3,529,412 shares of common stock and accompanying warrants [1][3]. Offering Details - The combined offering price for each share of common stock and accompanying warrants was set at $1.70, with pre-funded warrants priced at $1.699 [2]. - The pre-funded warrants have an exercise price of $0.001 per share and are exercisable immediately upon issuance, while the warrants have an exercise price of $1.70 per share and require shareholder approval for exercise [2]. Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may include working capital and capital expenditures [3]. Regulatory Compliance - The securities were offered under a shelf registration statement on Form S-3, which was filed with the SEC on December 8, 2023, and declared effective on December 22, 2023 [4]. - The warrants issued in the concurrent private placement were offered under Section 4(a)(2) of the Securities Act of 1933 and have not been registered under the Act or applicable state securities laws [5]. Company Overview - SeaStar Medical is a commercial-stage therapeutic medical technology company focused on developing extracorporeal therapies aimed at reducing excessive inflammation in vital organs [7]. - The company is innovating solutions for critically ill patients by targeting effector cells that drive systemic inflammation [7].

Core Viewpoint - SeaStar Medical Holding Corporation has entered into a securities purchase agreement for the issuance and sale of 3,529,412 shares of common stock and accompanying warrants, aiming to raise approximately $6 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering and a concurrent private placement, with a combined offering price of $1.70 per share and accompanying warrants [1]. - The pre-funded warrants will have an exercise price of $0.001 per share and will be exercisable immediately upon issuance [1]. - The warrants will have an exercise price of $1.70 per share, exercisable upon shareholder approval, and will expire five years after the approval date [1][2]. Group 2: Financial Advisor and Closing Conditions - H.C. Wainwright & Co. is acting as the exclusive financial advisor for SeaStar Medical in connection with this offering [2]. - The closing of the offering is expected around February 3, 2025, subject to customary closing conditions [2]. Group 3: Regulatory Compliance - The shares and warrants are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The securities offered in the registered direct offering will be available through a prospectus filed with the SEC [3]. Group 4: Company Overview - SeaStar Medical is a commercial-stage therapeutic medical technology company focused on developing extracorporeal therapies to mitigate excessive inflammation in critically ill patients [5]. - The company aims to provide innovative solutions targeting effector cells that drive systemic inflammation, which can cause direct tissue damage [5].

Core Insights - SeaStar Medical Holding Corporation has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a leading pediatric medical center in California, increasing its commercial customer base to five [1][2] - The company aims to expand the use of QUELIMMUNE to over 20 hospitals within the year, with ongoing efforts to secure additional hospital clearances and institutional review board (IRB) approvals [2][3] Company Overview - SeaStar Medical is a commercial-stage therapeutic medical device company focused on developing solutions to mitigate hyperinflammation effects on vital organs [1][6] - The company’s QUELIMMUNE device is specifically designed for critically ill children suffering from acute kidney injury (AKI) and sepsis, approved by the FDA under a Humanitarian Device Exemption (HDE) [3][6] Product Details - QUELIMMUNE targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), aiming to reduce hyperinflammation and promote organ recovery [5][6] - The device has received FDA Breakthrough Device Designation for four indications, highlighting its potential in treating severe conditions [6][7] Market Context - Acute Kidney Injury (AKI) can lead to severe complications, including multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4] - The innovative approach of QUELIMMUNE may provide a unique solution in a market with limited treatment options for critically ill pediatric patients [3][4]

Core Viewpoint - SeaStar Medical Holding Corporation is advancing its NEUTRALIZE-AKI pivotal trial for its Selective Cytopheretic Device (SCD) aimed at treating acute kidney injury (AKI) and has received FDA Breakthrough Device Designation for this indication [1][2][8]. Group 1: Trial Progress and Enrollment - Mayo Clinic has been cleared to enroll subjects in the NEUTRALIZE-AKI trial, increasing the number of activated sites to 15 [1]. - Current enrollment in the trial stands at 76, with six subjects enrolled since the beginning of the year, aiming to reach 100 subjects for an interim analysis soon [2][4]. Group 2: Trial Details - The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the SCD in 200 adults with AKI in the ICU receiving continuous renal replacement therapy (CRRT) [3]. - The primary endpoint is a composite of 90-day mortality or dialysis dependency, with secondary endpoints including 28-day mortality and major adverse kidney events at Day 90 [3]. Group 3: Device and Market Potential - The SCD employs immunomodulating technology to target proinflammatory cells during CRRT, aiming to reduce hyperinflammation and promote organ recovery [7]. - The estimated annual U.S. total addressable market for the SCD in adult AKI is between $4.7 billion and $6.3 billion, indicating significant commercial potential [6].

Core Insights - SeaStar Medical Holding Corporation has received FDA approval for an investigational device exemption to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD-ADULT) in adult patients with acute heart failure and worsening renal function [1][2] - The feasibility study will enroll 20 patients across five clinical sites and is funded by a $3.6 million NIH grant awarded to Innovative BioTherapies [2][3] - The total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome is estimated to exceed $1 billion annually, presenting a significant commercial opportunity for SeaStar Medical [3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing solutions to mitigate hyperinflammation's effects on vital organs [8] - The company is developing cell-directed extracorporeal therapies that target inflammatory cells, aiming to reduce systemic inflammation and promote organ recovery [8] Technology Details - The Selective Cytopheretic Device (SCD) utilizes immunomodulating technology to target proinflammatory neutrophils and monocytes, potentially leading to long-term organ recovery and reducing the need for future renal replacement therapy [5] - The SCD has also received FDA Breakthrough Device Designation for other indications beyond cardiorenal syndrome with LVAD [6]

Core Points - SeaStar Medical Holding Corporation has received FDA approval for an investigational device exemption to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD-ADULT) in adult patients with acute heart failure and worsening renal function [1][2] - The feasibility study will enroll 20 patients across five clinical sites and is funded by a $3.6 million NIH grant awarded to Innovative BioTherapies [2] - The SCD-ADULT targets hyperinflammation in patients with cardiorenal syndrome, potentially improving their condition for left ventricular assist device (LVAD) implantation [3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing solutions to mitigate hyperinflammation's effects on vital organs [8] - The company is developing cell-directed extracorporeal therapies that target inflammatory cells, aiming to reduce systemic inflammation and promote organ recovery [8] - The total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome is estimated to exceed $1 billion annually, presenting a significant commercial opportunity [3] Technology Details - The Selective Cytopheretic Device (SCD) is designed to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy, aiming to reduce hyperinflammation and promote organ recovery [5] - The SCD has received FDA Breakthrough Device Designation for multiple indications, including cardiorenal syndrome with LVAD [6]

Core Insights - SeaStar Medical Holding Corporation has shipped its QUELIMMUNE™ device to a major academic medical center, marking its fourth commercial customer [1] - The QUELIMMUNE device is designed to treat critically ill children in the ICU suffering from acute kidney injury (AKI) and sepsis, demonstrating clinical results that reduce mortality and dialysis dependency [2][3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing proprietary solutions to mitigate hyperinflammation effects on vital organs [8] - The company is pioneering cell-directed extracorporeal therapies that target inflammatory cells, aiming to provide life-saving solutions for critically ill patients [8] Product Details - QUELIMMUNE is a Selective Cytopheretic Device (SCD) that employs immunomodulating technology to target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) [5] - The device has received FDA approval under a Humanitarian Device Exemption (HDE) for use in children with AKI and sepsis, weighing 10 kilograms or more [3] Clinical and Economic Impact - Data indicates that AKI patients treated with QUELIMMUNE had no dialysis dependency 60 days post-treatment, potentially saving healthcare systems approximately $100,000 per patient annually due to avoided dialysis costs [3] - The average hospital cost for pediatric ICU patients with AKI exceeds $350,000, highlighting the economic benefits of adopting QUELIMMUNE [3]