DENVER, March 27, 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 financial results for the three months and year ended December 31, 2024, and provided business updates on key initiatives. "Our significant accomplishment in 2024 position us well for a transformational year in 2025," said Eric Schlorff, SeaStar Medical ...

Webcast Today at 4:30 pm Eastern TimeDENVER, March 27, 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 financial results for the three months and year ended December 31, 2024, and provided business updates on key initiatives. “Our significant accomplishment in 2024 position us well for a transformational year in 2025, ...

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].

DENVER, Jan. 31, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU) (SeaStar Medical) today announced it has entered into a securities purchase agreement with a single institutional investor for the issuance and sale of an aggregate of 3,529,412 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering. In a concurrent private placement, the Company also agreed to issue and sell to the investor warrants to purchase up to an aggregate of 3,529, ...

DENVER, Jan. 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage therapeutic medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has shipped QUELIMMUNE™ to a California medical center recognized as a world leader in pediatric research and treatments, increasing commercial customers to five. QUELIMMUNE is the company’s Selective Cytopheretic Device (SCD) for treating critically ill children in ...

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 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 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]