- CEO
- Eric Schlorff
- Full Time Employees
- 19
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- 3513 Brighton Boulevard Denver CO United States of America 80216
- IPO Date
- Mar 18, 2021
- Business
- SeaStar Medical Holding Corporation (Nasdaq: ICU) is a commercial-stage medical technology company that develops and commercializes proprietary extracorporeal therapies to mitigate the effects of hyperinflammation on vital organs in critically ill patients. The company's core offering is the patented Selective Cytopheretic Device (SCD), a disease-modifying extracorporeal synthetic membrane device that selectively targets and neutralizes over-activated neutrophils and monocytes to halt cytokine storms and destructive hyperinflammation; it integrates into existing continuous renal replacement therapy (CRRT) circuits using regional citrate anticoagulation. Key products include QUELIMMUNE, an FDA-approved SCD therapy via Humanitarian Device Exemption for pediatric patients with acute kidney injury (AKI) due to sepsis/septic shock; NEUTRALIZE-AKI, an SCD therapy in pivotal clinical trials for adult patients with AKI requiring CRRT; and pipeline applications in cardiorenal syndrome, hepatorenal syndrome, and myocardial stunning in end-stage renal disease.
Recent developments include FDA approval in December 2025 to reduce the SAVE Surveillance Registry enrollment for QUELIMMUNE from 300 to 50 patients based on strong safety data from the first 21 commercial uses, which demonstrated zero device-related adverse events and 70% survival at 90 days versus a typical 50% rate; three new top-ranked children's hospitals adopted QUELIMMUNE in Q3 2025, driving net revenue to $183,000 from $68,000 year-over-year. The company raised $12.4 million in Q3 2025 through equity offerings and warrant exercises to support the NEUTRALIZE-AKI trial expansion with additional sites showing early favorable efficacy; it also received the 2025 Corporate Innovator Award from the National Kidney Foundation in January 2025 and appointed Michael Messinger as Chief Financial Officer. QUELIMMUNE sales in early Q4 2025 already exceeded full Q3 totals, reflecting growing market traction in the estimated $100 million U.S. pediatric AKI segment.
SeaStar Medical operates primarily in the healthcare equipment sector, targeting ICU patients with acute and chronic inflammatory conditions including AKI, with broad potential in cardiovascular and hepatorenal diseases; its therapies address over 200,000 annual U.S. adult AKI cases requiring CRRT. The company focuses on U.S. markets through hospital partnerships and aims for expanded reimbursement via Breakthrough Device Designations for six indications. Founded in 2007 and headquartered in Denver, Colorado, SeaStar Medical resulted from a 2022 business combination with LMF Acquisition Opportunities, Inc., a SPAC sponsored by LM Funding America, Inc., and maintains a single reportable device segment with no noted subsidiaries.