DENVER, Jan. 08, 2025 (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 the shipment of its QUELIMMUNE™ device to a prominent academic medical center, representing SeaStar Medical's fourth commercial customer. QUELIMMUNE is the company's Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39927 SEASTAR MEDICAL HOLDING CORPORATION (Exact name of Registrant as specified in its Charter) Delaware 85-3681132 (State ...

Exhibit 99.1 SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update DENVER (November 13, 2024) – SeaStarMedical 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 de ...

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 ...