SeaStar Medical Reports Third Quarter 2026 Financial Results and Provides Business Updates

(NASDAQ:ICU) SeaStar Medical Holding Corporation reported financial results for the three months ended September 30, 2026, and provided business updates. Eric Schlorff, CEO, stated that QUELIMMUNE therapy adoption in the ultra-rare pediatric AKI market is strong and that the company is building momentum in educating the critical care pediatric healthcare community. Dr. Kevin Chung, CMO, presented statistically significant higher survival in QUELIMMUNE-treated patients at ASN Kidney Week 2026. The NEUTRALIZE-AKI pivotal clinical trial has enrolled nearly 75% of its intended 339 patients, with 251 enrolled to date, and the first module of the premarket approval application has been submitted to the FDA. SeaStar Medical received Breakthrough Device Designation from the FDA for the SCD therapy for hyperinflammation in adult patients with sepsis or a septic condition, marking the seventh such designation for the SCD therapy. The company received dedicated ICD-10-PCS codes from CMS effective October 1, 2026, enabling administrative, billing, and statistical reporting for SCD therapy in AKI patients requiring RRT. Net revenue for Q3 2026 was $0.6 million, up 247% from $0.2 million in Q3 2025, driven by increased sales of QUELIMMUNE. Gross profit margins remained above 90%. Cost of goods sold was $48 thousand in Q3 2026 versus $14 thousand in Q3 2025. Research and development expenses were $3.6 million in Q3 2026 compared to $1.9 million in Q3 2025, primarily due to increased clinical research activities for NEUTRALIZE-AKI, SCD development, and personnel costs. General and administrative expenses were $1.6 million in Q3 2026 versus $1.9 million in Q3 2025, with the decrease attributed to lower personnel, legal, audit, and SEC-related costs, partially offset by higher professional services, director fees, and franchise taxes. Other income (net) was $0.1 million in Q3 2026 compared to other expense of $0.1 million in Q3 2025. Net loss for Q3 2026 was $4.5 million, or $1.03 per share on 4.4 million weighted-average shares outstanding, compared to a net loss of $3.5 million, or $1.30 per share, on 2.7 million weighted-average shares outstanding in Q3 2025. Cash at September 30, 2026, was $4.0 million, not including $3.3 million of gross proceeds from warrant exercises in October 2026, compared to $12.0 million at December 31, 2025. The QUELIMMUNE (SCD-PED) therapy is commercialized for children with AKI and sepsis or a septic condition weighing 10 kilograms or more and aged ≤22 years, approved in February 2024 under a Humanitarian Device Exemption. Data from two clinical trials published in Kidney Medicine showed a 77% survival rate in patients treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. The NEUTRALIZE-AKI pivotal trial is evaluating SCD therapy in 339 adults with AKI in the ICU receiving CRRT, with primary and secondary endpoints including 90-day mortality or dialysis dependency, 28-day mortality, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year. The study will also include subgroup analyses for AKI patients with sepsis and acute respiratory distress syndrome. The company will hold a third quarter financial results conference call on November 11, 2026, at 4:30 p.m. ET.

FDA Confirms SeaStar Medical Has Fulfilled the Post-Approval Study Requirements for QUELIMMUNE® for the Treatment of Sepsis-Associated Acute Kidney Injury (AKI) in Pediatric Patients

(NASDAQ:ICU) SeaStar Medical Holding Corporation announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE. Eric Schlorff, CEO of SeaStar Medical, stated that this decision will enable the company to expand the potential life-saving benefits of QUELIMMUNE therapy to more critically ill children with life-threatening acute kidney injury (AKI). Children with life-threatening AKI typically have about a 50% survival rate with traditional supportive care alone. Results from the SAVE Registry were presented at ASN Kidney Week 2026, highlighting a clinically meaningful and statistically significant improvement in 90-day survival of 65.1% for QUELIMMUNE (SCD-PED) patients (N=43) compared to 47.5% for patients from the Kids’ Inpatient Database (KID) (N=196), with a P value of 0.043. No device-related adverse events were reported in the SAVE Registry patients. Statistically significant increases for both in-hospital and 60-day survival were also observed for patients treated with QUELIMMUNE (SCD-PED) compared to KID cohorts. KID is the largest publicly available, all-payer pediatric inpatient care database in the United States. Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, emphasized the importance of the SAVE Registry in providing real-world evidence on safety and probable benefits in these patients. FDA’s decision now allows hospitals to use QUELIMMUNE therapy without the research infrastructure previously required by the SAVE Registry, expanding access to critically ill pediatric patients with sepsis-associated AKI on renal replacement therapy (RRT). SeaStar Medical will continue to voluntarily enroll patients in the SAVE Registry at participating medical centers. The QUELIMMUNE therapy has been adopted by many of the highest rated children’s medical centers in the United States. The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy. QUELIMMUNE (SCD-PED) therapy is commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more and aged ≤22 years who are on antibiotics and being treated in the ICU with RRT. QUELIMMUNE was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials published in Kidney Medicine showed a 77% survival rate in patients treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia, with additional risks including blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation. The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous renal replacement therapy (CRRT), with a primary endpoint of a composite of 90-day mortality or dialysis dependency. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. The study will also include subgroup analyses for AKI patients with sepsis and acute respiratory distress syndrome. SeaStar Medical’s SCD therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI requiring continuous RRT, a condition that impacts over 200,000 adults in the United States annually.