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) presented expanded real-world SAVE Registry pediatric data and investigator research at AKI & CRRT 2026. The registry showed no device-related adverse events and 69% survival at Day 28 and Day 60. In vitro gene-expression work indicates the SCD shifts monocytes toward an anti-inflammatory, reparative phenotype. The company hosted a pediatric AKI symposium and an Advanced Practice Provider Panel to promote QUELIMMUNE (SCD-PED) adoption.
SeaStar Medical (Nasdaq: ICU) reported 2025 results and program milestones on March 25, 2026. Net revenue rose to approximately $1.2M (2025) from $135K (2024); net loss narrowed to ~$12.2M. The company completed the SAVE pediatric registry, exceeded 50% enrollment in NEUTRALIZE-AKI (181/339), and began a cardio-renal trial.
Cash improved to $12.0M at year-end; management plans modular PMA submissions and anticipates ~$2M in 2026 product revenue with expanded pediatric adoption.
SeaStar Medical (Nasdaq: ICU) will report fourth quarter and year-end 2025 financial results after market close on Wednesday, March 25, 2026. A live webcast and conference call will follow at 4:30 p.m. ET / 2:30 p.m. MT, with a replay available after 7:30 p.m. ET.
Preregistration is required to join the live call; a pin and dial-in information will be provided upon registration.
SeaStar Medical (Nasdaq: ICU) announced completion of required enrollment in the SAVE Registry, a FDA post-approval study confirming QUELIMMUNE safety for pediatric acute kidney injury (AKI) requiring renal replacement therapy.
The registry enrolled 50 patients; the company will report 28-day safety results to the FDA after analysis. Early results were published in Pediatric Nephrology and QUELIMMUNE is in use at multiple major U.S. children’s hospitals.
SeaStar Medical (Nasdaq: ICU) announced publication in Pediatric Nephrology reporting early post-approval real-world results from the SAVE Registry for QUELIMMUNE (SCD-PED) in pediatric AKI with sepsis.
In 21 patients there were no device-related adverse events, Day‑28/60 survival 76%, Day‑90 survival 71%, and dialysis‑free rates of 75% at Day‑28 and 83% at Day‑90 for non‑ESRD/non‑recent transplant survivors.
SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference on Thursday, February 5, 2026 at 11:30 AM ET.
Live registration is available and a replay will be posted on Monday, February 9, 2026 after 11:30 AM ET and remain available for 30 days.
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.