SeaStar Medical Expands NEUTRALIZE-AKI Pivotal Trial Adding Two Premier Military Medical Facilities
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
DENVER , Oct. 08, 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 the activation of Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR), expanding the number of sites in its NEUTRALIZE-AKI pivotal trial. This trial is evaluating the safety and efficacy of SeaStar Medical’s innovative Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT). With the inclusion of these prestigious military medical facilities, SeaStar Medical now has 11 active clinical sites with 48 subjects enrolled to date. The SCD has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to the SCD as a therapy to treat a serious or
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News
- SeaStar Medical Reaches Milestone of 100th QUELIMMUNE Commercial Device as Shipments Begin to its Third Hospital CustomerGlobeNewswire
- SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business UpdateGlobeNewswire
- FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic DialysisGlobeNewswire
- Record Monthly Enrollment Achieved in SeaStar Medical’s Pivotal Adult AKI TrialGlobeNewswire
- SeaStar Medical Adds Second Hospital Customer for QUELIMMUNEGlobeNewswire
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Sec Filings
- 11/19/24 - Form 4
- 11/19/24 - Form 4
- 11/15/24 - Form 4
- ICU's page on the SEC website