SeaStar Medical Holding Corp（ICU）资讯与事件ICUSeaStar Medical Holding Corp

SeaStar Medical's Quelimmune Meets FDA Post-Approval Study Requirements

SeaStar Medical announced the Center for Biologics Evaluation and Research, or CBER, of the FDA has determined that the Quelimmune Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption approval of Quelimmune. "We are grateful for this decision by FDA and believe it will enable us to expand the potential life-saving benefits of our Quelimmune therapy to more critically ill children with life-threatening AKI," stated Eric Schlorff, CEO of SeaStar Medical. "These kids typically have about a 50% survival rate with traditional supportive care alone, and we believe this decision will be a win-win for patients, their families, health care providers, and the overall health care system."

Selling Stockholders Plan to Sell Up to 1.77M Shares

This filing relates to the offer and sale from time to time by the selling stockholders of up to 1.77M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.

SeaStar Medical Releases QUELIMMUNE Study Data, 90-Day Survival Rate at 65.1%

SeaStar Medical announced new data from the late-breaking presentation at ASN Kidney Week 2026 in Denver, Colorado. The late-breaking poster, titled "Improved Outcomes in Pediatric Sepsis-Associated AKI: Comparison of the Selective Cytopheretic Device for Pediatrics Surveillance Registry with a Historical Cohort," compared survival in QUELIMMUNE-treated critically ill pediatric patients from its post-approval SAVE registry and one non-registry patient with life-threatening acute kidney injury and sepsis requiring CRRT with clinically aligned cohorts from Kids' Inpatient Database, the largest publicly available, all-payer pediatric inpatient care database in the United States representing broad clinical complexity. To assess the robustness of the findings, the authors used a multi-pronged analytic approach that included both Bayesian and frequentist methods across primary, landmark, and time-to-event analyses. Key results are reported. A separate safety analysis of QUELIMMUNE-treated patients was also presented. Summary of Key Highlights: Day 90 Survival: The primary exposure-defined analysis at Day 90 resulted in a statistically significant increase in survival of the QUELIMMUNE cohort achieving 65.1% survival compared to 47.4% for the KID cohort, representing more than double the odds of survival for QUELIMMUNE-treated patients. The Bayesian probability of higher survival in QUELIMMUNE patients was 98.2%. A second landmark sensitivity analysis favored the QUELIMMUNE cohort achieving 63.8% Day 90 survival, an increase of 15.1 percentage points over the KID cohort survival of 48.7%, representing 86% higher estimated odds of survival. The Bayesian probability of higher survival in the QUELIMMUNE landmark cohort was 96.8%. In-Hospital Survival: Survival to hospital discharge was significantly higher with the QUELIMMUNE cohort compared to KID in the primary analysis. Bayesian analyses were directionally consistent, with 98.5% and 97.3% posterior probabilities of higher QUELIMMUNE survival in the primary and landmark analyses, respectively. Mortality: All four Day 90 mortality models favored the QUELIMMUNE cohort showing 34% to 40% reduction in estimated hazard of mortality compared with combined KID. While frequentist models did not reach statistical significance, both Bayesian time-to-death models exceeded the 95% probability threshold, providing supportive evidence of a lower mortality hazard with QUELIMMUNE therapy. Renal Replacement Therapy Independence: 20 of the 24 survivors in the QUELIMMUNE cohort who did not require RRT at baseline were independent of RRT at 90 days. Adverse Events: No device-related AEs occurred in patients treated with the QUELIMMUNE therapy from SAVE registry patients. All new bloodstream infections within 28 days of SCD-PED initiation were adjudicated by an independent data and safety monitoring board to be unrelated to QUELIMMUNE therapy. Statistical Design and Analyses: The observational external-control exploratory study compared all known eligible QUELIMMUNE-treated pediatric patients with available outcome data through completion of the pre-specified SAVE enrollment target of 50 patients versus clinically aligned patients from the 2019 and 2022 Healthcare Cost and Utilization Project Kids' Inpatient Databases. KID is the largest publicly available all-payer pediatric inpatient care database in the United States, containing unweighted data from over three million pediatric discharges per data year, representing a broad range of patients, comorbidities, and complexities, including extracorporeal membrane oxygenation, thus provided the broadest available pediatric comparator population. Both cohorts included critically ill pediatric patients with life-threatening AKI and sepsis requiring CRRT with high clinical complexities, such as malignancy, immunocompromised status and transplant. Greater than 95% required invasive mechanical ventilation, vasopressor use, and/or management for shock in both groups. Advanced life support therapy, such as ECMO, was administered in 33% to 34% of patients in the SAVE cohort and 28% to 29% of patients in the KID cohort. The primary exposure-defined analysis compared the QUELIMMUNE cohort patients who received greater than one day of QUELIMMUNE therapy versus clinically aligned patients in the KID cohort. The landmark sensitivity analysis compared the QUELIMMUNE cohort patients who were alive one day post-initiation of QUELIMMUNE therapy versus patients from the KID cohort who survived beyond one calendar day of CRRT initiation. Safety outcomes for the QUELIMMUNE cohort included new bloodstream infections and Day 90 renal replacement therapy-free status among survivors not RRT-dependent at baseline.