SeaStar Medical (ICU) Life Sciences Virtual Investor Forum summary

Company overview and therapeutic focus

• Focuses on treating hyperinflammation in critically ill patients, targeting organ failure from conditions like acute kidney injury and cardiovascular disease.

• Offers QUELIMMUNE for Children, an FDA-approved product, and a pipeline with Breakthrough Device designations to accelerate approvals.

• Selective Cytopheretic Device (SCD) is a first-in-class, disease-modifying therapy for acute and chronic kidney diseases, as well as cardiovascular, liver, and lung conditions.

• SCD neutralizes overactive immune cells, reducing mortality and dialysis dependency in clinical studies.

Mechanism of action and clinical impact

• SCD integrates into existing dialysis circuits, using regional citrate anticoagulation to lower calcium and induce apoptosis in activated neutrophils and monocytes.

• Therapy gently restores immune homeostasis, quelling cytokine storms responsible for organ damage.

• Clinical studies show improved survival and reduced long-term dialysis in pediatric patients.

Pediatric program and registry updates

• Registration study showed 77% survival and no long-term dialysis at day 60 in children.

• SAVE Registry, a post-approval study, confirmed consistent real-world outcomes with clinical trials.

• FDA reduced required SAVE Registry patients from 300 to 50; enrollment target achieved, awaiting 28-day safety data before submission.

• Onboarding at pediatric centers expected to accelerate as registry requirements ease.

• Targeting top 50 of 220 US children's hospitals, aiming to double customer base by end of 2026.