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]

Core Viewpoint - SeaStar Medical Holding Corporation has activated 14 sites for the NEUTRALIZE-AKI pivotal trial, which is assessing the safety and efficacy of its Selective Cytopheretic Device (SCD) for treating acute kidney injury (AKI) in ICU patients undergoing continuous renal replacement therapy (CRRT) [1][9]. Market Opportunity - The annual U.S. total addressable market for the SCD in adult AKI is estimated to be between $4.7 billion and $6.3 billion, presenting a significant opportunity relative to the clinical trial costs of approximately $15 million [2]. Clinical Trial Details - The NEUTRALIZE-AKI trial aims to enroll up to 200 adults, with the primary endpoint being a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CRRT [11]. - As of now, 70 subjects have been enrolled, with an interim analysis planned at the trial's 90-day primary endpoint [9]. Device Technology - The SCD is a patented cell-directed extracorporeal device that utilizes immunomodulating technology to target proinflammatory neutrophils and monocytes during CRRT, aiming to reduce hyperinflammation and improve organ recovery [13]. Regulatory Status - The SCD has received FDA Breakthrough Device Designation for adults with AKI, indicating it may offer substantial improvement over existing therapies [10].

DENVER, Dec. 04, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that management will hold a conference call to discuss business progress and updates. Date/Time:Wednesday, December 11, 4:30 p.m. ET / 1:30 p.m. PT  Pre-Registration: Participants can pre-register for the conference call here:   Callers who pre-register will be given a ...

SeaStar Medical urges stockholders to vote FOR all proxy proposals prior to the Special Meeting of Stockholders to be held November 26, 2024 DENVER, Nov. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the two leading independent institutional advisory firms, Institutional Shareholder Services (ISS) and Glass Lewis, have bo ...

DENVER, Nov. 15, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has begun shipping QUELIMMUNE™ to a third hospital customer. QUELIMMUNE is the Company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis. “Within weeks of implementing our direct ...

DENVER, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2024, and provides a business update. “We are delighted to report market demand and our first commercial sales of QUELIMMUNE™, our pediatric SCD that was cleared for ...

The partnership creates one of the largest global IV solutions manufacturing networks with combined production of an estimated 1.4 billion annual units and aims to bring additional supply chain resiliency and new innovation to the North American IV solutions market. Joint venture becomes part of a global manufacturing network with scale and redundancy Intends to add long-term supply resiliency and accelerate IV solutions new product development in North America Combines Otsuka Pharmaceutical Factory, Inc.'s ...