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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) announced sponsorship of key educational initiatives to improve critical care for pediatric patients with acute kidney injury (AKI), a complication linked to high ICU mortality and prolonged hospital stays. According to SeaStar Medical, more than 50% of children with severe AKI in ICUs lose their lives.
The company is sponsoring and participating in the KidneyBee Summit 2026, held July 14–16, 2026 at Children’s Hospital Colorado, and is also sponsoring an August 11, 2026 webinar on QUELIMMUNE (SCD-PED), its first-in-class device-based therapy for pediatric sepsis-associated AKI.
SeaStar Medical (Nasdaq: ICU) received dedicated ICD-10-PCS codes from CMS for its Selective Cytopheretic Device (SCD) therapy used in acute kidney injury requiring renal replacement therapy in inpatient hospitals.
The codes support standardized billing for QUELIMMUNE (SCD-PED) and future SCD therapies and take effect October 1, 2026. SeaStar Medical estimates the adult AKI market is about 50 times larger than the pediatric market, or approximately $4.5 billion.
SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present at the Virtual Investor Summit Conference on Wednesday, June 24 at 10:30 a.m. Eastern Time.
Investors can register to watch the live presentation and access a replay on the SeaStar Medical events and presentations section of the company website for up to 30 days after posting.
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.