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 ...

SAN CLEMENTE, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- ICU Medical (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced that Company management will present at the UBS Global Healthcare Conference being held in Rancho Palos Verdes, California, November 11-14, 2024. ICU Medical’s presentation will be on Wednesday, November 13, 2024 at 4:15 p.m. PT (7:15 p.m. ET). Company management will also be participating in one-on-one meetings on Wednesday, Nov ...

DENVER, Nov. 01, 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, reports setting a new monthly enrollment record with 10 critically ill acute kidney injury (AKI) patients added to the NEUTRALIZE-AKI pivotal trial during the past month, bringing total enrollment to 56. This trial is evaluating the safety and efficacy of the Company’s proprieta ...

Core Insights - SeaStar Medical has successfully shipped its Selective Cytopheretic Device (SCD), QUELIMMUNE, to a second hospital, marking a significant step in its direct sales model [1][2] - The company aims to have QUELIMMUNE available in four to five leading pediatric hospitals by the end of 2024, highlighting its growth strategy and market penetration efforts [2] Product Overview - QUELIMMUNE is designed for critically ill children with acute kidney injury (AKI) and sepsis, and it has received FDA approval under a Humanitarian Device Exemption (HDE) [1][3] - The device is expected to reduce hospitalization costs by approximately $30,000 per patient, primarily due to lower death rates and shorter hospital stays compared to standard care [3] Economic Impact - The cost of treating pediatric patients with AKI on continuous renal replacement therapy (CRRT) exceeds $460,000 per hospitalization, indicating a substantial market opportunity for QUELIMMUNE [3] - The device's implementation could lead to significant healthcare savings while providing critical care to very sick children [2][3] Regulatory and Operational Aspects - QUELIMMUNE requires Institutional Review Board (IRB) approval from each hospital before commercial sales can occur, which includes training for critical care teams [5] - The company is actively working to secure additional IRB clearances and expand its customer base under HUD requirements [2][5] Clinical Development - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the SCD's safety and effectiveness in adults with AKI, with the adult version of the device receiving FDA Breakthrough Device Designation [8] - The SCD technology aims to modulate the immune response in patients, potentially improving long-term organ recovery and reducing the need for future renal replacement therapy [7][8] Company Background - SeaStar Medical is focused on developing innovative medical technologies that address excessive inflammation in critically ill patients, with a commitment to improving patient outcomes through its proprietary therapies [9]

SAN CLEMENTE, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq: ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced the time of its third quarter 2024 earnings release and conference call. The Company will release its third quarter 2024 results on Tuesday, November 12th, 2024 at approximately 4:00 p.m. ET (1:00 p.m. PT) and will be conducting a conference call concerning those results at 4:30 p.m. ET (1:30 p.m. PT) on Tuesday, November ...