SeaStar Medical (ICU) Registration Filing summary

Company overview and business model

• Commercial-stage healthcare company developing the Selective Cytopheretic Device (SCD) to treat hyperinflammation in critically ill patients, with initial focus on acute and chronic kidney disease and other inflammatory conditions.

• SCD received FDA approval under Humanitarian Device Exemption for pediatric acute kidney injury (AKI) due to sepsis; first commercial pediatric SCD shipped in July 2024.

• Pivotal clinical trial underway for SCD in adult AKI patients requiring continuous renal replacement therapy (CRRT); device designed for integration with existing hospital CRRT systems.

• SCD platform awarded Breakthrough Device Designation for six indications, including adult AKI, cardiorenal syndrome, hepatorenal syndrome, ESRD, and cardiac surgery.

• Business combination completed in October 2022, resulting in current corporate structure.

Financial performance and metrics

• As of December 31, 2024, 5,977,246 shares of common stock issued and outstanding; no preferred stock outstanding.

• Company qualifies as a smaller reporting company and emerging growth company, providing reduced public disclosure and reporting requirements.

• Independent auditor's report includes a going concern explanatory paragraph.

Use of proceeds and capital allocation

• Will not receive proceeds from resale of shares by the selling securityholder.

• May receive up to $6,000,000 in gross proceeds if all warrants are exercised in cash at $1.70 per share; proceeds to be used for working capital and general corporate purposes.

• Management has broad discretion over use of proceeds from warrant exercises.