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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) 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).
SeaStar Medical (NASDAQ: ICU) has announced a registered direct offering priced at-the-market, aiming to raise $4.4 million in gross proceeds. The company will issue 4,960,544 shares of common stock at $0.887 per share.
Additionally, in a concurrent private placement, SeaStar will issue unregistered warrants to purchase up to 4,960,544 shares with an exercise price of $0.762 per share. The warrants will be exercisable immediately and expire after five years. The offering, managed by H.C. Wainwright & Co., is expected to close around August 1, 2025.
The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures.
SeaStar Medical (Nasdaq: ICU) has reported positive preliminary results from its SAVE Surveillance Registry for the QUELIMMUNE therapy in treating pediatric patients with acute kidney injury (AKI) and sepsis. The data from the first 20 pediatric patients showed 75% survival rate through 28 days, potentially exceeding a 50% reduction in mortality compared to historical data.
The therapy demonstrated no device-related safety events and was particularly effective in critically ill patients who received it as a last resort. The company plans to collect Real-World Evidence (RWE) for up to 300 patients, including 90-day survival and dialysis dependency data. The QUELIMMUNE therapy, based on Selective Cytopheretic Device (SCD) technology, has been implemented at leading U.S. children's medical centers and has received FDA Breakthrough Device Designation for six different applications.
SeaStar Medical (Nasdaq: ICU) announced the addition of a major Texas-based children's hospital to its QUELIMMUNE therapy customer base. QUELIMMUNE, FDA-approved in 2024 under Humanitarian Device Exemption, treats pediatric patients with ultra-rare Acute Kidney Injury due to sepsis requiring Renal Replacement Therapy.
The company's SAVE Surveillance Registry is collecting safety and organ-related outcomes data comparing QUELIMMUNE to standard care. Additionally, the NEUTRALIZE-AKI pivotal trial has enrolled 119 of 200 planned adult subjects, with interim analysis results expected in Q3. The company holds FDA Breakthrough Device Designation for six indications, including various inflammatory and renal conditions.
SeaStar Medical (NASDAQ: ICU) has announced a $4 million registered direct offering priced at-the-market under Nasdaq rules. The company will issue 5,242,464 shares of common stock at $0.763 per share.
Additionally, in a concurrent private placement, SeaStar Medical will issue unregistered warrants to purchase up to 5,242,464 shares with an exercise price of $0.638 per share. The warrants will be exercisable immediately and expire in five years. H.C. Wainwright & Co. serves as the exclusive placement agent, with the offering expected to close around July 10, 2025.
The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures.
SeaStar Medical (NASDAQ: ICU) announced that Texas Children's Hospital has adopted its QUELIMMUNE therapy for treating pediatric patients with Acute Kidney Injury (AKI). The therapy, FDA-approved in 2024 under a Humanitarian Device Exemption, has shown remarkable results with a 77% survival rate compared to standard care, representing a 50% reduction in mortality.
The Selective Cytopheretic Device (SCD) therapy works by neutralizing over-active immune cells and stopping cytokine storms in critically ill patients. Clinical data showed no dialysis requirement for survivors at Day 60 post-ICU discharge. The company is currently conducting the NEUTRALIZE-AKI pivotal trial in 200 adults and has received FDA Breakthrough Device Designation for six different indications.
SeaStar Medical (NASDAQ:ICU) has successfully met Nasdaq's minimum stockholders' equity requirement of $2.5 million and all other criteria for continued listing on The Nasdaq Capital Market, resolving its previous listing concerns.
CEO Eric Schloff emphasized that the company can now focus on commercializing QUELIMMUNE and advancing their clinical development of the Selective Cytopheretic Device (SCD) therapy in the NEUTRALIZE-AKI pivotal trial for adult patients with Acute Kidney Injury receiving continuous renal replacement therapy.