Welcome to our dedicated page for SeaStar Medical Holding news (Ticker: ICU), a resource for investors and traders seeking the latest updates and insights on SeaStar Medical Holding stock.
SeaStar Medical Holding Corporation (Nasdaq: ICU) generates news that centers on its development and commercialization of therapies based on its patented Selective Cytopheretic Device (SCD) technology for critically ill patients. Company press releases highlight progress with its first commercial product, QUELIMMUNE (SCD-PED) therapy, which is approved by the U.S. Food and Drug Administration under a Humanitarian Device Exemption for life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients receiving Renal Replacement Therapy.
News updates frequently cover commercial adoption milestones for QUELIMMUNE, including new top-rated children’s hospitals that begin using the therapy and real-world outcomes reported through the SAVE Surveillance Registry. These releases often describe survival data, safety findings such as zero device-related adverse events, and registry enrollment updates that may influence the therapy’s market opportunity.
Investors following ICU news also see regular coverage of clinical development for SCD therapy in adult AKI and cardiovascular indications. This includes announcements related to the NEUTRALIZE-AKI pivotal trial in adults with AKI requiring continuous renal replacement therapy, DSMB recommendations, enrollment progress, and the initiation of studies such as the NEUTRALIZE-CRS trial in patients with acute chronic systolic heart failure and cardiorenal syndrome awaiting LVAD implantation.
Additional SeaStar Medical news items include regulatory and FDA interactions, such as Breakthrough Device Designations for multiple therapeutic indications and adjustments to post-approval surveillance requirements for QUELIMMUNE. Corporate updates, including reverse stock split actions, equity financings, financial results, and executive appointments, are also disclosed through press releases and associated SEC filings. For readers tracking ICU, the news stream provides insight into commercial traction, clinical trial status, regulatory milestones, and key corporate decisions that shape the company’s SCD-based therapy platform.
SeaStar Medical (Nasdaq: ICU) outlined 2026 milestones to expand commercial adoption of QUELIMMUNE for ultra-rare pediatric AKI, advance its Selective Cytopheretic Device (SCD) therapy in adult AKI and acute CHF with cardiorenal syndrome, and pursue rapid regulatory pathways.
Key figures: SeaStar expects approximately $2.0 million in net product revenue in 2026, plans to add 15 children’s medical centers to more than double site count, aims to complete enrollment of the NEUTRALIZE-AKI pivotal trial (339 patients) near end of 2026, and to initiate a modular PMA process and additional Breakthrough and Humanitarian Device designation requests.
SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present at the Biotech Showcase 2026 investor conference at the Hilton Union Square in San Francisco on January 13, 2026 at 3:00 p.m. Pacific Standard Time. The presentation will be streamed live on the company website and a replay will be posted at approximately 6:00 p.m. PST on January 13, 2026 and remain available for up to 30 days after posting.
SeaStar management will also meet with investors in San Francisco during the 44th Annual J.P. Morgan Healthcare Conference from January 12–14, 2026.
SeaStar Medical (Nasdaq: ICU) announced a 1-for-10 reverse stock split effective 12:01 a.m. ET on January 5, 2026, with post-split trading beginning at the open on January 5, 2026.
The reverse split will convert every 10 pre-split shares into 1 share, change the CUSIP to 81256L302, and proportionally adjust outstanding stock options and certain warrants. Stockholders entitled to fractional shares will receive one whole share instead of fractional shares. The company said the objective is to increase the market price to help regain compliance with Nasdaq's $1.00 minimum bid rule.
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.
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