Thu, Mar 27, 9:21 PM (30 days ago)
**Summary of SeaStar Medical Holding Corporation's 10-K Filing:** **Financial Performance (2024 vs. 2023):** - **Revenue:** $135,000 vs. $0 (2023). - **Net Loss:** $24.8 million vs. $26.2 million (2023). - **Research & Development Expenses:** $9.1 million vs. $5.9 million (2023). - **General & Administrative Expenses:** $8.9 million vs. $8.2 million (2023). **Strategic Overview:** - **Product:** SeaStar Medical's primary product is the Selective Cytopheretic Device (SCD), designed to reduce hyperinflammation in critically ill patients. - **Market Position:** The company focuses on treating acute kidney injury (AKI) in pediatric and adult patients. - **Regulatory Approvals:** Received FDA approval for pediatric SCD (QUELIMMUNE) in February 2024 and is conducting pivotal trials for adult SCD. **Future Outlook:** - **Clinical Trials:** Ongoing pivotal trial for adult SCD with 94 patients enrolled as of March 2025. - **Commercialization:** Plans to expand commercial operations and increase customer base. - **Funding:** Seeking additional capital to support operations and clinical trials. **Risk Factors:** - **Financial:** Significant operating losses and negative cash flows. - **Regulatory:** Dependence on FDA approvals and potential delays in clinical trials. - **Market:** Competition and reimbursement challenges. **Financial Condition:** - **Cash Position:** $1.8 million as of December 31, 2024. - **Debt:** Extinguished all notes payable to LMFA, LMFAO, and Maxim for $5.4 million. - **Equity Financing:** Raised $17.7 million through equity offerings in 2024. **Market Position Changes:** - **Product Sales:** Shipped first commercial pediatric SCD in July 2024. - **Customer Base:** Adding new commercial accounts and working through IRB processes. **Amendments (if applicable):** - **Distribution Agreement:** Terminated agreement with Nuwellis and paid $900,000 in settlement. **Note:** All amounts are in thousands, except per-share data.