SeaStar Medical Holding (ICU) investor relations material

Key technology and clinical platform

• QUELIMMUNE Selective Cytopheretic Device (SCD) targets immune-related renal injuries, with FDA approval for pediatric acute kidney injury (AKI) with sepsis under a humanitarian device exemption in 2024.

• SCD is a platform technology with a consistent mechanism of action across multiple acute and chronic indications, including both pediatric and adult populations.

• Adult indications are under breakthrough device designation, with six indications in the pipeline and a pivotal registration study underway for adult AKI.

• The device modulates immune response by selectively binding and neutralizing activated neutrophils and monocytes, reducing cytokine storm without immunosuppression.

• SCD is used in conjunction with continuous renal replacement therapy (CRRT), inducing apoptosis in targeted immune cells and returning them to the body to signal resolution of inflammation.

Market opportunity and commercialization

• Pediatric AKI market in the U.S. is valued at $100 million with about 4,000 patients annually; adult AKI market is 50 times larger, with a $4.5 billion annual potential and over 200,000 patients.

• QUELIMMUNE for children launched in July 2024, with initial adoption in eight U.S. pediatric hospitals and a focus on the top 50 children's hospitals.

• Sales and distribution are managed directly, reducing middleman fees and improving hospital experience.

• Health economics show reduced hospital stays and cost savings, with hospitals profiting from SCD use in pediatric AKI.

• Strategy includes building a patient registry and deploying a specialized nursing team for smooth adoption.

Clinical results and ongoing studies

• Pediatric clinical studies showed a survival rate increase to 77% and no dialysis dependency at 60 days, with no serious adverse events or infections.

• Early SAVE registry data confirm a 75% survival rate in real-world pediatric use; further data to be presented in September.

• Adult pivotal study (NEUTRALIZE-AKI) is 60% enrolled, targeting 200 patients, with a 90-day endpoint of all-cause mortality or dialysis dependency.

• Interim analysis of the first 100 patients is expected in Q3, with final PMA submission planned for the second half of 2026.

• Study sites include major academic, military, and community hospitals, with CMS reimbursement for trial participation.