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SeaStar Medical Holding Corp (ICU) is a medical technology innovator developing extracorporeal therapies to combat hyperinflammation's impact on vital organs. This page serves as the definitive source for verified company news and regulatory developments.
Investors and healthcare professionals will find timely updates on clinical trial progress, FDA regulatory milestones, and strategic partnerships shaping the future of inflammation management. Our curated news collection covers essential developments including product innovations, research collaborations, and market expansion efforts.
All content undergoes rigorous verification to ensure accuracy regarding SeaStar Medical's patented technologies and their clinical applications. Regular updates provide insights into the company's progress in commercializing therapies that target cytokine storms and immune system modulation.
Bookmark this page for streamlined access to breaking news about ICU's medical device advancements, peer-reviewed research findings, and healthcare sector initiatives. Check back frequently for objective reporting on developments impacting both patient care and investment considerations.
SeaStar Medical (Nasdaq: ICU) announced the FDA's Center for Biologics Evaluation and Research approved reducing the mandatory SAVE Surveillance Registry enrollment from 300 to 50 patients for post‑approval monitoring of QUELIMMUNE, the pediatric AKI therapy approved in 2024.
To date, 32 pediatric patients have been entered, and early registry data from the first 21 patients showed zero device‑related adverse events and improved survival (76% at Day 28/60; 71% at Day 90). SeaStar estimates the U.S. pediatric AKI market at $100 million and says the reduction should ease adoption and commercial rollout.
SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present at NobleCon21 on Wednesday, December 3, 2025 at 4:00 PM ET at Florida Atlantic University in Boca Raton, Florida.
Investors and guests may register using code ICUNOBLECON. A replay will be posted on the company website on Thursday, December 4, 2025 after 4:00 PM ET and will remain available for 30 days following posting.
SeaStar Medical (Nasdaq: ICU) appointed Michael Messinger as Chief Financial Officer on November 17, 2025. Messinger brings over 25 years of healthcare finance experience, including service as CFO at ContraFect where he led the company through a 2014 Nasdaq IPO, multiple financings and a $90 million BARDA contract. He currently serves on the board of Filament Health and consults for biotech companies.
SeaStar emphasized Messinger's financial and operational experience as the company grows commercial operations for its QUELIMMUNE (SCD-PED) therapy and seeks additional commercial opportunities in pediatric AKI and other indications.
SeaStar Medical (Nasdaq: ICU) reported Q3 2025 results and business updates on Nov 13, 2025. Key operational items: QUELIMMUNE commercial use showed preliminary survival of 76% at 60 days and 71% at 90 days in 21 pediatric patients from the SAVE registry, and three top-ranked children’s hospitals added QUELIMMUNE orders, with Q4 orders to date exceeding Q3 orders. The NEUTRALIZE-AKI pivotal trial interim DSMB review showed a positive signal and no device-related safety issues, and total enrollment target was increased from 200 to ~339 patients with 146 enrolled to date. The company raised $12.4 million in the quarter. Financials: Q3 revenue ≈ $0.2M, net loss ≈ $3.5M, and cash of $13.8M at Sep 30, 2025.
SeaStar Medical (Nasdaq: ICU) will report Q3 2025 financial results after market close on Thursday, November 13, 2025, and will host a webcast and conference call at 4:30 p.m. ET / 2:30 p.m. MT with a replay available after 7:30 p.m. ET.
SeaStar is a commercial-stage healthcare company whose first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024 for life-threatening pediatric AKI due to sepsis. The company’s Selective Cytopheretic Device (SCD) has earned Breakthrough Device Designation for six indications and SeaStar is conducting a pivotal adult AKI trial for patients requiring CRRT, a condition the release estimates affects over 200,000 adults annually in the U.S.
SeaStar Medical (NASDAQ: ICU) announced positive preliminary results from the SAVE Surveillance Registry for its QUELIMMUNE therapy in treating pediatric Acute Kidney Injury (AKI). The data, presented at the 5th International Symposium on AKI in Children, showed impressive outcomes from the first 21 pediatric patients with AKI and sepsis requiring Renal Replacement Therapy (RRT).
Key results include zero device-related adverse events, a 76% survival rate at Days 28 and 60, and 71% survival at Day 90. Among ECMO patients, the therapy demonstrated a 60% survival rate at Day 90. For survivors without prior ESRD or recent kidney transplant, 82% were dialysis-free at Day 90.
The SAVE Registry will continue collecting Real-World Evidence for up to 300 patients to support broader adoption and inform payer discussions.SeaStar Medical (NASDAQ: ICU) announced that the independent Data Safety Monitoring Review Board (DSMB) has recommended continuing the NEUTRALIZE-AKI pivotal trial for their Selective Cytopheretic Device (SCD) therapy in adult AKI patients. The interim analysis of the first 100 patients revealed zero device-related safety issues and showed potential clinical benefits in the treatment group.
Based on these findings, the DSMB recommended increasing trial enrollment from 200 to 339 patients to strengthen statistical power. Currently, 137 patients are enrolled, with completion expected by late 2026. The trial's primary endpoint evaluates 90-day mortality or dialysis dependency in SCD therapy patients versus standard care.
Notably, the company's SCD therapy, marketed as QUELIMMUNE™, is already FDA-approved for pediatric AKI patients, showing promising results with 75% patient survival through 28 days in initial commercial use.
SeaStar Medical (Nasdaq: ICU) announced the upcoming presentation of preliminary results from the SAVE Surveillance Registry at the 5th International Symposium on Acute Kidney Injury in Children. The presentation will focus on QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy.
Two abstracts will be presented on September 27, 2025, covering early post-approval real-world clinical experience and the SAVE Registry study design. The registry aims to collect Real-World Evidence from up to 300 patients, tracking 90-day survival, dialysis dependency, and safety data.
SeaStar Medical (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, announced its participation in the HC Wainwright 27th Annual Global Investment Conference.
The company's presentation is scheduled for September 5, 2025, at 7:00 am ET. Investors can access the presentation through the Events & Presentations page in the Investor Relations section of SeaStar Medical's website, where it will remain available for 60 days after the event.
SeaStar Medical (NASDAQ: ICU) has published a health economic analysis demonstrating significant cost savings with their QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) patients. The study, published in the Journal of Medical Economics, projects $69,146 savings per hospitalization compared to standard continuous renal replacement therapy (CRRT).
The analysis reveals that QUELIMMUNE therapy could potentially offset its own costs during the median 6-day treatment period. Key findings show a 77% survival rate with QUELIMMUNE versus standard care, representing a ~50% reduction in mortality. The therapy demonstrates a 98% probability of higher survival odds with a predicted risk difference of 22.4%. The cost reduction is attributed to a 3-day shorter hospital stay and improved survival rates.
QUELIMMUNE received FDA approval in 2024 under a Humanitarian Device Exemption for pediatric AKI patients due to sepsis requiring Renal Replacement Therapy. The company is currently conducting the NEUTRALIZE-AKI pivotal trial in 200 patients.
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