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SeaStar Medical Holding (ICU) investor relations material
SeaStar Medical Holding H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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.
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