SeaStar Medical Expands Pediatric AKI Footprint, Advances Adult Trial
Event summary
- Added 3 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025.
- Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI, enrolling 223 of 339 patients to date.
- Obtained ICD-10-PCS codes to enable standardized inpatient hospital billing for its selective cytopheretic device (SCD) therapy, including QUELIMMUNE.
- Reported net revenue of $0.6 million for Q2 2026, up from $0.3 million in Q2 2025.
The big picture
SeaStar Medical is making strides in both its pediatric and adult AKI markets. The addition of top-rated children’s hospitals to its QUELIMMUNE customer base underscores growing acceptance of its therapy in the pediatric critical care community. Meanwhile, progress in the NEUTRALIZE-AKI trial positions the company to tap into a significantly larger adult market, pending FDA approval. The strategic acquisition of ICD-10-PCS codes further streamlines billing processes, potentially enhancing commercial adoption.
What we're watching
- Trial Completion Timing
- Whether SeaStar Medical can complete enrollment in the NEUTRALIZE-AKI trial by year-end or early 2027, enabling a PMA application to the FDA near the end of 2027.
- Regulatory Approval Pathway
- The pace at which SeaStar Medical progresses its modular Premarket Approval (PMA) application for SCD therapy in the adult AKI market.
- Market Expansion Potential
- How the expansion into the adult AKI market, 50 times larger than the pediatric market, will impact SeaStar Medical's revenue and shareholder value.
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