SeaStar Medical Holding Earnings Call Transcripts
Fiscal Year 2026
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SCD therapy targets hyperinflammation at its source, showing strong survival benefits and no device-related adverse events in pediatric AKI, with a robust pipeline expanding into adult and cardiorenal indications. Commercialization is advancing, supported by FDA approvals, CMS reimbursement, and a clean financial position.
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QUELIMMUNE net revenue grew 69% year-over-year in Q1 2026, with seven new hospital adoptions and strong gross margins. The NEUTRALIZE-AKI pivotal trial for adult AKI is progressing, and the SAVE Registry reached 50-patient enrollment. Cash reserves increased to $9.3 million.
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The session highlighted a novel device-based approach to treating hyperinflammation, with strong pediatric results and ongoing adult trials. Key milestones include expanding hospital adoption, advancing pivotal studies, and pursuing regulatory and commercial growth.
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Focused on stopping organ failure via a unique device platform, the company has launched QUELIMMUNE for pediatric AKI, showing strong survival benefits and cost savings. Adult pivotal studies are underway, with a robust pipeline and financial health supporting expansion.
Fiscal Year 2025
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QUELIMMUNE sales and adoption surged in 2025, driving revenue growth and improved margins. SCD therapy for adult AKI advanced in pivotal trials, with strong cash position and reduced losses supporting expansion into larger markets.
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Q3 2025 saw strong revenue growth, high gross margins, and expanding adoption of QUELIMMUNE therapy, with positive survival data in pediatric patients. NEUTRALIZE-AKI trial enrollment is on track, and new clinical trials and capital raises support future growth.
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QUELIMMUNE SCD is FDA approved for pediatric AKI with sepsis and is now being commercialized, with strong early clinical results showing improved survival and no dialysis dependency. A pivotal adult trial is underway, targeting a multi-billion dollar market, with interim data expected in Q3 2025.
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Q2 revenue rose 15% sequentially to $338,000, driven by expanded QUELIMMUNE adoption and strong registry survival data. NEUTRALIZE-AKI trial enrollment reached 125 of 200, and $12.4M in new equity was raised, with an additional $8.6M post-quarter.
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Q1 revenue quadrupled sequentially, driven by increased QUELIMMUNE adoption at pediatric sites. NEUTRALIZE-AKI trial for adult AKI reached 50% enrollment, with a large market opportunity ahead. Two new FDA breakthrough designations expand the pipeline.
Fiscal Year 2024
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First FDA-approved product QUELIMMUNE launched for pediatric AKI, with growing hospital adoption and initial revenues. NEUTRALIZE-AKI pivotal trial for adult AKI is progressing, with interim analysis expected mid-2025. Multiple Breakthrough Device designations and strong financial management position the company for significant market expansion.