SeaStar Medical Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

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SeaStar Medical
SeaStar Medical

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DENVER, March 27, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months and year ended December 31, 2024, and provided business updates on key initiatives.

“Our significant accomplishment in 2024 position us well for a transformational year in 2025,” said Eric Schlorff, SeaStar Medical CEO. “Last year, we not only received our first product approval for QUELIMMUNE and began our commercial launch, but we added 14 new clinical sites for our NEUTRALIZE AKI pivotal clinical trial, which has led to steady progress in enrollment with 94 of our anticipated 200 patients enrolled in the trial. We were also awarded our fourth Breakthrough Device Designation which should enable us to speed up the review and approval processes for our Selective Cytopheretic Device (SCD) therapy for these indications.”

Mr. Schlorff continued, “And I am pleased to report that our momentum has continued this year. We have added new commercial customers and have a healthy pipeline of prospective customers in the process of adopting the QUELIMMUNE therapy. We activated two additional sites in our NEUTRALIZE AKI pivotal clinical trial, and the FDA approved a feasibility study for our SCD therapy as a treatment for cardiorenal syndrome as a bridge to left ventricular assist device. We secured additional capital to support planned operations and just last week the National Kidney Foundation announced that SeaStar Medical has been awarded its 2025 Corporate Innovator Award for our significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of our QUELIMMUNE therapy. We are very pleased with our progress.”

Key Business Highlights in 2024 and Beyond

During 2024, and into the first three months of 2025, StarStar Medical’s achievements have included the following:

  • Granted approval by the FDA through a Humanitarian Device Exemption (HDE) for the QUELIMMUNE therapy for use in pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition requiring continuous renal replacement therapy (CRRT), an ultra-rare condition impacting approximately 4,000 pediatric patients annually.

  • Launched the QUELIMMUNE therapy, achieving adoption by five customers to date, and expanded the pipeline of new customers in the process of adopting the QUELIMMUNE therapy.

  • Successfully executed on the NEUTRALIZE AKI pivotal trial, enrolling 94 patients to date. Clinical sites, including the prestigious centers at Stanford Medical Center, Cleveland Clinic, and Mayo Clinic, are actively enrolling new patients in this trial that is designed to evaluate the safety and efficacy of the SCD therapy in 200 adults with AKI in the Intensive Care Unit (ICU) receiving CRRT.

  • Awarded Breakthrough Device Designation to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis.

  • Announced that the National Institutes of Health awarded a $3.6 million grant for a clinical trial to evaluate the SCD therapy as a bridging strategy to left ventricular assist device implantation in patients with chronic heart failure who have progressed to acute decompensated heart failure.

  • Expanded awareness of the SCD therapy in the medical community through peer-reviewed publications in the European Journal of Heart Failure, Transplantation Direct, Nature Scientific Reports as well as presentations at the American Society of Nephrology’s Kidney Week meeting.

  • Awarded by the National Kidney Foundation the NKF 2025 Corporate Innovator Award for the significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

  • Expanded the proprietary protection for the SCD through the award of U.S. Patent No. 11,866,730 with broad claims directed to methods of using the SCD therapy to treat subjects with inflammatory conditions and to process activated leukocytes and platelets, and through the Canadian Intellectual Property Office for issuance of Canadian Patent No. 2814586 covering broad claims for the SCD technology.

  • Substantially improved the company’s balance sheet through the addition of approximately $31 million in capital as well as a reduction in debt and liabilities.