SeaStar Medical Holding (ICU) investor relations material

Key presentations and technology overview

• QUELIMMUNE Selective Cytopheretic Device (SCD) is FDA approved for pediatric acute kidney injury (AKI) with sepsis under a humanitarian device exemption as of 2024.

• The device targets immune-related renal injuries by modulating neutrophils and monocytes, reducing hyperinflammation without immunosuppression.

• SCD is being commercialized for children and is in pivotal trials for adult AKI, with a PMA filing planned for 2026.

• The same mechanism of action applies across multiple acute and chronic indications, with several adult uses under breakthrough device designation.

• The device is positioned as a platform technology with broad application potential.

Clinical data and market opportunity

• Pediatric AKI market is valued at $100 million annually, while the adult AKI market is estimated at $4.5 billion, with over 200,000 U.S. patients yearly.

• Clinical studies in children showed survival rates improved to 77%, with no patients dialysis-dependent at 60 days and no serious adverse events.

• Early registry data in children confirm a 75% survival rate in a high-risk population.

• Adult pivotal trial is 60% enrolled, targeting 200 patients, with interim analysis expected in Q3 and final data in 2026.

• The device is also being studied for other indications, including cardiorenal syndrome, end-stage renal disease, and systemic inflammatory response.

Commercialization and strategic plans

• QUELIMMUNE launched in July 2024, with initial focus on the top 50 U.S. children's hospitals; eight hospitals are currently using the device.

• The company maintains direct control over sales and distribution, aiming to expand to 20 hospital systems in 2025.

• Health economics show reduced hospital stays and cost savings, supporting commercial adoption.

• A patient registry is mandated by the FDA, and early results are being tracked for ongoing assessment.

• Additional capital of $8.6 million was raised in July, with a clean capital structure and no interest-bearing debt.