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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 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.
SeaStar Medical (NASDAQ: ICU) has undertaken several measures to regain compliance with Nasdaq's listing requirements after receiving a notification of non-compliance in June 2024. The company completed a $4.0 million public offering and secured a $15.0 million purchase agreement with Lincoln Park Capital.
The company has expanded its customer base to six facilities for QUELIMMUNE, its FDA-approved product for pediatric patients with multiple organ failure, which has shown to reduce mortality by approximately 50%. Additionally, SeaStar implemented cost-cutting measures and restructured approximately $1.2 million in employee compensation liabilities. The company believes these actions have helped it meet the $2.5 million stockholders' equity requirement for continued Nasdaq listing, pending formal confirmation.
SeaStar Medical (NASDAQ: ICU) announced a two-part video series featuring their QUELIMMUNE therapy at Cincinnati Children's Hospital Medical Center. The first video, available June 24, 2025, features Dr. Stuart Goldstein and CMO Dr. Kevin Chung discussing QUELIMMUNE's potential to reduce destructive hyperinflammation in organ failure cases.
The second video, releasing June 26, 2025, showcases a patient testimonial from Kurt and his father, describing Kurt's rapid recovery from post-heart surgery complications using QUELIMMUNE therapy. Both videos will be accessible through SeaStar Medical's investor relations website.