SeaStar Medical Conference Summary Company Overview - **Company Name**: SeaStar Medical - **Ticker Symbol**: ICU (NasdaqCM) - **Focus**: Treating hyperinflammation in critically ill patients, particularly those facing organ failure or life-threatening conditions such as Acute Kidney Injury and cardiovascular diseases [4][5] Core Products and Pipeline - **FDA-Approved Product**: QUELIMMUNE for Children - **Pipeline**: Includes the Selective Cytopheretic Device (SCD), which has received Breakthrough Device designation from the FDA for various applications [4][5] - **Market Opportunity**: Approximately 1 million patients annually could benefit from SCD, with significant revenue potential from capturing even a modest market share [5] Clinical Data and Efficacy - **SCD Mechanism**: A therapeutic medical device that neutralizes overactive immune cells, reducing mortality and dialysis dependency [6][10] - **Pediatric Study Results**: - Registration study with 22 patients showed a 50% improvement in survival rates (from 50% to 77%) and no long-term dialysis patients at Day 60 [14][15] - SAVE Registry confirmed similar results in real-world settings, with a reduction in mortality and dialysis dependency [15][16] - **Regulatory Updates**: FDA approved a reduction in the number of patients required for the SAVE Registry from 300 to 50, with 50 patients now enrolled [17][18] Commercial Strategy - **Customer Base Growth**: - End of 2024: 2 active customers - End of 2025: 10 customers - Goal for 2026: Double the customer base [22] - **Target Market**: Focus on the top 50 children's hospitals in the U.S., which represent half of the eligible patient population [22][23] Ongoing Trials - **NEUTRALIZE-AKI Trial**: - A randomized controlled study with 339 patients, currently 40% enrolled [25] - Primary endpoints include mortality rates and dialysis dependency [26] - Expected to complete enrollment by the end of 2026, with top-line data available in the first half of 2027 [29] Competitive Advantage - **Comparison with Standard Care**: Current standard of care (Continuous Renal Replacement Therapy) has a 50% mortality rate and is not disease-modifying. SCD aims to improve outcomes significantly [34] - **Economic Benefits**: QUELIMMUNE can reduce ICU length of stay and overall healthcare costs, potentially saving hospitals $40,000 to $50,000 per patient [35] Future Opportunities - **Cardiorenal Syndrome**: SCD may help patients bridge to LVAD or transplant by reducing inflammation [37] - **Regulatory Pathways**: Plans to submit modular pieces for PMA to expedite the approval process [30][31] Financial Overview - **Revenue Projections**: Expected to generate over $1 million in revenue for QUELIMMUNE in 2025, with a goal to double that in 2026 [40] - **Cash Position**: As of November, approximately $13.5 million in cash, with a monthly burn rate of $1 million to $1.3 million [41] Key Milestones for Investors - Completion of NEUTRALIZE-AKI enrollment - Doubling the customer base for QUELIMMUNE - Progress in NEUTRALIZE-CRS study and potential regulatory applications [50][51]

As filed with the Securities and Exchange Commission on August 8, 2025 Registration No. 333- (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) 3513 Brigh ...

REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on September 8, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Code Number) 3513 Brighton Blvd, Suite 410 Denver, CO 80216 (844) 427-8100 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Eric Schlorff Chief Executive Officer 3513 Brighton Blvd. Suite 410 Denver, CO 80216 UNDER THE S ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on July 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on April 24, 2023 Registration No.333-271215 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 3513 Brighton Blvd, Suite 410 Denver, CO 80216 (844) 427-8100 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation ( ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on April 11, 2023 Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S. Em ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on January 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I. ...

Table of Contents Index to Financial Statements REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on January 4, 2023 Registration No. 333-268503 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Prima ...