SeaStar Medical (ICU) Registration filing summary

Company overview and business model

• Commercial-stage healthcare business developing an extracorporeal Selective Cytopheretic Device (SCD) designed to modulate activated immune cells and reduce destructive hyperinflammation; platform targets acute and chronic organ-failure indications.

• Pediatric SCD therapy QUELIMMUNE received FDA Humanitarian Device Exemption approval on February 21, 2024; first commercial shipment was in July 2024.

• SCD integrates with existing continuous renal replacement therapy systems; development includes a pivotal adult AKI trial and a feasibility study in adults with cardiorenal syndrome awaiting LVAD implantation.

Financial performance and metrics

• October 2026 cash exercise of prior warrants generated ~$3.3m gross proceeds before placement-agent fees and offering expenses.

• Auditor’s report on FY2025 and FY2024 consolidated financial statements includes an explanatory paragraph about substantial doubt concerning ability to continue as a going concern.

Use of proceeds and capital allocation

• No proceeds from selling stockholders’ resale sales; cash exercise of all registered warrants could generate ~$6.5m gross proceeds for general corporate purposes.

• Management has broad discretion over warrant-exercise proceeds; registration expenses are borne by the issuer, while selling stockholders pay selling commissions and transfer taxes.