SeaStar Medical Advances NEUTRALIZE-AKI Trial with Over 60% Enrollment, Plans 2026 PMA Filing for SCD Therapy

Reuters

2025/08/14

SeaStar Medical Advances NEUTRALIZE-AKI Trial with Over 60% Enrollment, Plans 2026 PMA Filing for SCD Therapy

SeaStar Medical Holding Corporation has announced significant progress in its clinical trials and market expansion. The company has reached the 50% patient enrollment milestone in its NEUTRALIZE-AKI pivotal clinical trial, with 125 of the anticipated 200 patients now enrolled. Interim analysis results from the trial's independent Data Safety Monitoring Review Board are expected in the third quarter of 2025. Additionally, SeaStar Medical has expanded its QUELIMMUNE customer base by securing three top-rated U.S.-based children's hospitals. Positive survival results have been reported for the first 20 pediatric patients treated with QUELIMMUNE in a commercial setting, as part of the SAVE Surveillance Registry. The company plans to file a Pre-Marketing Approval application for its Selective Cytopheretic Device therapy in 2026, contingent upon successful trial outcomes.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001831868-25-000006), on August 13, 2025, and is solely responsible for the information contained therein.

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The company has reached the 50% patient enrollment milestone in its NEUTRALIZE-AKI pivotal clinical trial, with 125 of the anticipated 200 patients now enrolled. Interim analysis results from the trial's independent Data Safety Monitoring Review Board are expected in the third quarter of 2025. Additionally, SeaStar Medical has expanded its QUELIMMUNE customer base by securing three top-rated U.S.-based children's hospitals. Positive survival results have been reported for the first 20 pediatric patients treated with QUELIMMUNE in a commercial setting, as part of the SAVE Surveillance Registry. 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ID: 0001831868-25-000006), on August 13, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"ICU","symbol_name":"SeaStar Medical Holding Corporation","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250813:nNDL6V6DKb:1","article_id":"2559981321","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2559981321","pubTimestamp":1755116376,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"SeaStar Medical Holding Corporation has announced significant progress in its clinical trials and market expansion. The company has reached the 50% patient enrollment milestone in its NEUTRALIZE-AKI pivotal clinical trial, with 125 of the anticipated 200 patients now enrolled. Interim analysis results from the trial's independent Data Safety Monitoring Review Board are expected in the third quarter of 2025. Additionally, SeaStar Medical has expanded its QUELIMMUNE customer base by securing three top-rated U.S.-based children's hospitals. Positive survival results have been reported for the first 20 pediatric patients treated with QUELIMMUNE in a commercial setting, as part of the SAVE Surveillance Registry. 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Interim analysis results from the trial's independent Data Safety Monitoring Review Board are expected in the third quarter of 2025. Additionally, SeaStar Medical has expanded its QUELIMMUNE customer base by securing three top-rated U.S.-based children's hospitals. Positive survival results have been reported for the first 20 pediatric patients treated with QUELIMMUNE in a commercial setting, as part of the SAVE Surveillance Registry. The company plans to file a Pre-Marketing Approval application for its Selective Cytopheretic Device therapy in 2026, contingent upon successful trial outcomes.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001831868-25-000006), on August 13, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}