SeaStar Medical Holding Corp Stock Price, News & Analysis

SeaStar Medical (Nasdaq: ICU) will report Q3 2025 financial results after market close on Thursday, November 13, 2025, and will host a webcast and conference call at 4:30 p.m. ET / 2:30 p.m. MT with a replay available after 7:30 p.m. ET.

SeaStar is a commercial-stage healthcare company whose first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024 for life-threatening pediatric AKI due to sepsis. The company’s Selective Cytopheretic Device (SCD) has earned Breakthrough Device Designation for six indications and SeaStar is conducting a pivotal adult AKI trial for patients requiring CRRT, a condition the release estimates affects over 200,000 adults annually in the U.S.

SeaStar Medical (NASDAQ: ICU) announced positive preliminary results from the SAVE Surveillance Registry for its QUELIMMUNE therapy in treating pediatric Acute Kidney Injury (AKI). The data, presented at the 5th International Symposium on AKI in Children, showed impressive outcomes from the first 21 pediatric patients with AKI and sepsis requiring Renal Replacement Therapy (RRT).

Key results include zero device-related adverse events, a 76% survival rate at Days 28 and 60, and 71% survival at Day 90. Among ECMO patients, the therapy demonstrated a 60% survival rate at Day 90. For survivors without prior ESRD or recent kidney transplant, 82% were dialysis-free at Day 90.

SeaStar Medical (NASDAQ: ICU) announced that the independent Data Safety Monitoring Review Board (DSMB) has recommended continuing the NEUTRALIZE-AKI pivotal trial for their Selective Cytopheretic Device (SCD) therapy in adult AKI patients. The interim analysis of the first 100 patients revealed zero device-related safety issues and showed potential clinical benefits in the treatment group.

Based on these findings, the DSMB recommended increasing trial enrollment from 200 to 339 patients to strengthen statistical power. Currently, 137 patients are enrolled, with completion expected by late 2026. The trial's primary endpoint evaluates 90-day mortality or dialysis dependency in SCD therapy patients versus standard care.

Notably, the company's SCD therapy, marketed as QUELIMMUNE™, is already FDA-approved for pediatric AKI patients, showing promising results with 75% patient survival through 28 days in initial commercial use.

SeaStar Medical (Nasdaq: ICU) announced the upcoming presentation of preliminary results from the SAVE Surveillance Registry at the 5th International Symposium on Acute Kidney Injury in Children. The presentation will focus on QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy.

Two abstracts will be presented on September 27, 2025, covering early post-approval real-world clinical experience and the SAVE Registry study design. The registry aims to collect Real-World Evidence from up to 300 patients, tracking 90-day survival, dialysis dependency, and safety data.

SeaStar Medical (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, announced its participation in the HC Wainwright 27th Annual Global Investment Conference.

The company's presentation is scheduled for September 5, 2025, at 7:00 am ET. Investors can access the presentation through the Events & Presentations page in the Investor Relations section of SeaStar Medical's website, where it will remain available for 60 days after the event.

SeaStar Medical (NASDAQ: ICU) has published a health economic analysis demonstrating significant cost savings with their QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) patients. The study, published in the Journal of Medical Economics, projects $69,146 savings per hospitalization compared to standard continuous renal replacement therapy (CRRT).

The analysis reveals that QUELIMMUNE therapy could potentially offset its own costs during the median 6-day treatment period. Key findings show a 77% survival rate with QUELIMMUNE versus standard care, representing a ~50% reduction in mortality. The therapy demonstrates a 98% probability of higher survival odds with a predicted risk difference of 22.4%. The cost reduction is attributed to a 3-day shorter hospital stay and improved survival rates.

QUELIMMUNE received FDA approval in 2024 under a Humanitarian Device Exemption for pediatric AKI patients due to sepsis requiring Renal Replacement Therapy. The company is currently conducting the NEUTRALIZE-AKI pivotal trial in 200 patients.

SeaStar Medical (NASDAQ: ICU) reported Q2 2025 financial results and significant business progress. The company achieved $0.3 million in revenue from QUELIMMUNE pediatric SCD therapy sales and posted a net loss of $2.0 million ($0.18 per share). Key highlights include enrolling 31 new patients in the NEUTRALIZE-AKI trial, reaching 125 of 200 planned patients, and securing three new top-rated children's hospitals as QUELIMMUNE customers.

The SAVE Surveillance Registry reported positive results with 75% survival rate through 28 days in pediatric patients. The company strengthened its financial position by raising $12.4 million through public and registered direct offerings, extending operations into 2026. Additionally, SeaStar received a notable $2 million DoD grant for research on SCD therapy in severe burns and inflammation treatment.

SeaStar Medical (Nasdaq: ICU), a commercial-stage healthcare company specializing in treatments for critically ill patients with organ failure, has scheduled its second quarter 2025 financial results announcement for August 13, 2025, after market close.

The company will host a conference call and webcast at 4:30 p.m. ET / 2:30 p.m. MT to discuss its financial performance and business updates. Investors can access the call using Conference ID 2078693, with dial-in numbers 1 (800) 715-9871 (U.S.) and 1 (646) 307-1963 (international). A replay will be available until August 20, 2025.

SeaStar Medical (NASDAQ: ICU) has achieved significant progress in its NEUTRALIZE-AKI pivotal clinical trial, reaching 125 patient enrollments, representing over 60% of the targeted 200 patients. The company has expanded its trial network to 16 clinical sites with the addition of Methodist Hospital Metropolitan in San Antonio, Texas.

The company remains on schedule for a third quarter 2025 interim analysis of the first 100 patients by the independent Data Safety Monitoring Review Board (DSMB). The trial includes prestigious institutions such as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center, focusing on evaluating SCD therapy for adult patients with Acute Kidney Injury (AKI).