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SeaStar Medical Holding Corporation develops and commercializes extracorporeal medical-device therapies for critically ill patients with organ failure driven by hyperinflammation. Its first commercial product, QUELIMMUNE (SCD-PED), is based on the company’s Selective Cytopheretic Device technology and is FDA approved for pediatric acute kidney injury associated with sepsis or a septic condition in patients requiring renal replacement therapy.
Recurring company updates cover QUELIMMUNE adoption by children’s hospitals, SAVE post-approval registry data, publications and conference presentations, and financial results. News also addresses clinical development of SCD therapy in adult acute kidney injury requiring continuous renal replacement therapy and in cardio-renal indications, as well as FDA Breakthrough Device and Humanitarian Device pathways for additional SCD uses.
SeaStar Medical (Nasdaq: ICU) reported Q1 2026 net revenue of $0.5 million from QUELIMMUNE, a 69% increase versus Q1 2025, after adding 7 top-rated children’s hospitals, bringing its pediatric AKI customer base to 17.
The company advanced enrollment to 198 of 339 patients in the NEUTRALIZE-AKI pivotal adult trial, completed SAVE Registry enrollment of 50 pediatric patients, and reported no device-related safety events with QUELIMMUNE. Q1 2026 net loss was $3.5 million, with $9.3 million in cash at March 31, 2026.
SeaStar Medical (Nasdaq: ICU) will report first quarter 2026 financial results after market close on Wednesday, May 13, 2026.
The company will host a webcast and conference call at 4:30 p.m. ET / 2:30 p.m. MT with preregistration required; a replay will be available after 7:30 p.m. ET.
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.