SeaStar Medical (ICU) H.C. Wainwright 27th Annual Global Investment Conference summary

Investment highlights and platform overview

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

• The SCD platform targets immune-related renal injuries and is being commercialized for children, with a pipeline expanding into multiple adult indications under breakthrough device designation.

• Adult AKI market opportunity is estimated at $4.5 billion annually, with over 200,000 patients in the U.S. each year.

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

• Clinical data show improved survival rates and no dialysis dependency at 60 days in both pediatric and adult populations.

Clinical development and results

• The pivotal NEUTRALIZE-AKI trial for adults is 60% enrolled, targeting a 200-patient randomized controlled study with a 90-day endpoint of 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.

• Early pediatric registry data show a 75% survival rate and reduced hospital stays, with no device-related serious adverse events or infections.

• The pediatric product launched in July 2024 and is being adopted by leading U.S. children's hospitals, with a focus on the top 50 centers.

• The same device mechanism is used across pediatric and adult indications, with size adjustments for children.

Commercial strategy and financials

• Direct sales and distribution model eliminates middleman fees, aiming for optimal hospital and customer experience.

• Hospitals using SCD in children see reduced length of stay and cost savings, supporting commercial adoption.

• Expansion plans include reaching 20 pediatric hospital systems in 2025 and completing adult pivotal study enrollment.

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

• The leadership team brings extensive experience from pharmaceutical and medical device sectors.