Financial Data and Key Metrics Changes - The company recorded its highest quarterly revenue to date, achieving a 15% increase in sequential quarter revenue through sales of Quellimmune therapy, with revenue for Q2 2025 at $338,000 compared to approximately $293,000 in Q1 2025 and $0 in Q2 2024 [27] - Year-to-date revenue reached $631,000, attributed to existing customers expanding their usage of Quellimmune and the addition of new hospital customers [27] - The net loss for Q2 2025 declined to $2,000,000 compared to a loss of $3,200,000 in Q2 2024 [28] Business Line Data and Key Metrics Changes - Quellimmune net revenue for Q2 increased 15% sequentially, with a nearly 370% increase in revenue in the first six months of launch compared to the previous year [6][11] - The company added three new customers for Quellimmune since the beginning of Q2, indicating strong enthusiasm for the therapy [10] Market Data and Key Metrics Changes - The total U.S. market opportunity for the adult SCD therapy is estimated to be over $4 billion annually, with a potential patient population of approximately 200,000 facing organ failure [12] - The company has received FDA breakthrough device designation for five additional indications, indicating a significant market potential for adult indications [13] Company Strategy and Development Direction - The company aims to complete the neutralized AKI pivotal trial for adults and prepare to file a PMA following the trial's completion [30] - The broader strategy includes expanding the use of FCD therapy across a range of hyper-inflammatory conditions beyond AKI, targeting both pediatric and adult populations [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future prospects for SeaStar Medical, particularly regarding the adult AKI market and the potential for significant revenue generation [31] - The company is focused on enrolling the right type of patients in clinical trials to demonstrate therapeutic effects effectively [19] Other Important Information - The company raised $12.4 million in new equity capital through public offerings and registered direct offerings [26] - The gross profit margin for Q2 was approximately 92%, reflecting the transition to recognizing COGS as the company moves into commercial operations [28] Q&A Session Summary Question: What are the expectations for the adult AKI pivotal trial? - Management expects to reach full enrollment by the end of the year and plans to file a PMA in 2026 if the data supports it [22][32] Question: How is the company addressing the enrollment pace in clinical trials? - The company is actively adding new sites and expanding screening into additional ICUs to optimize enrollment rates [21][22]

SeaStar Medical Holding (ICU) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants Jackie Kosman - Investor Relations AdvisorEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFO Operator Good afternoon, and thank you for standing by. My name is Calvin, and I will be your conference operator today. At this time, I would like to welcome everyone to the Seastar Star Medical Year End twenty twenty four Financial Results Conf ...