SeaStar Medical (ICU) investor relations material

Mission and therapy overview

• Focused on stopping organ failure and saving lives through the SCD therapy, which targets hyperinflammation at its source and is agnostic to disease state.

• SCD is the first and only therapy to neutralize destructive hyperinflammation, with six FDA breakthrough device designations and strong patent protection.

• High gross margins support an efficient commercialization strategy, initially targeting pediatric AKI in the US.

• SCD setup is a simple add-on to dialysis circuits, targeting activated immune cells to restore homeostasis.

• Pipeline includes approved pediatric product, pivotal NEUTRALIZE-AKI study, and NEUTRALIZE-CRS study for cardiorenal syndrome.

Clinical data and market opportunity

• Pediatric AKI market is $100 million annually, with 4,000 children affected in the US; adult market is 50 times larger at $4.5 billion.

• Registration study showed 50% increased survival, no dialysis dependency, and no device-related serious adverse events.

• Real-world SAVE Registry mirrored registration results, with 76% survival in sicker patients.

• Commercial focus is on top 50 US children's hospitals, with 17 patients treated as of March.

• Healthcare economics study showed $46,000 hospital savings per patient using SCD, supporting future price increases.

Adult and expanded indications

• Pivotal adult study (NEUTRALIZE-AKI) is 60% enrolled, targeting 339 patients with a 90-day composite endpoint of mortality or dialysis dependency.

• Study includes academic, military, and community hospitals to reflect real-world AKI incidence.

• CMS reimbursement in place for adult patients, with top-line data expected in early second half of 2027.

• NEUTRALIZE-CRS study explores intermittent therapy for cardiorenal syndrome, potentially expanding to chronic kidney disease.

• FDA humanitarian device exemptions and new approval pathways are being pursued for rapid commercialization.