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SeaStar Medical Holding Corporation develops devices that act on immune cells involved in excessive inflammation. Its commercial product, QUELIMMUNE, treats critically ill children with life-threatening acute kidney injury caused by sepsis or a septic condition. Used in a continuous kidney-replacement treatment circuit, the device temporarily captures activated immune cells, modifies their inflammatory activity and returns them to circulation. U.S. hospitals buy QUELIMMUNE directly from the company, and its current revenue depends on this product.
QUELIMMUNE has FDA approval under a Humanitarian Device Exemption, which limits annual sales volume. Hospitals must participate in the SAVE Surveillance Registry to monitor treated patients; institutional review board review and approval can slow adoption. SeaStar also depends on Fresenius Medical Care North America for its device cartridges and is developing another supply source.
Its adult device remains in clinical development, with a pivotal U.S. trial intended to support FDA approval for adults with acute kidney injury receiving continuous kidney-replacement treatment. It is not approved for adult use. Commercializing that treatment would require regulatory approval, hospital adoption and access to insurer or government reimbursement.
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Cytosorbents Corp. competes with SeaStar to serve critical-care teams treating inflammation with cartridges that process blood outside the body, though their mechanisms and approved markets differ. Watch its EU-approved CytoSorb business: its cartridges remove substances from blood, while SeaStar’s QUELIMMUNE treats critically ill children with sepsis-related acute kidney injury by modulating inflammatory cells.
SeaStar depends on Fresenius Medical Care for the critical blood-treatment cartridges used in its SCD devices, so uninterrupted manufacturing matters to both commercialization and clinical trials. The kidney-care company supplies these cartridges through an affiliate under an agreement running through December 31, 2027; watch supply continuity as SeaStar develops a second source for adult and pediatric cartridges.
Nuwellis sells Aquadex systems that remove excess fluid to hospitals, including pediatric centers SeaStar targets with QUELIMMUNE, but their former distribution agreement has ended. Watch Nuwellis’s pediatric revenue—about 40% of its revenue in 2025—for a view of this shared hospital customer group, not as a sales channel for SeaStar’s treatment of sepsis-related acute kidney injury.
Fresenius Medical Care AG earningsFMS
Fresenius Medical Care's report will show whether SeaStar Medical's critical blood-treatment cartridge supplier can keep supplying the parts needed for product shipments and clinical trials.
Watch what Fresenius Medical Care says about cartridge production and supply. Steady supply leaves SeaStar with a critical part for QUELIMMUNE shipments and adult-device trials; a disruption could constrain both until an alternative source is qualified and ready.
Nuwellis, Inc. earningsNUWE
Nuwellis's report will show whether some children's hospitals SeaStar Medical targets are still buying its fluid-removal systems, offering a read on shared hospital customers—not a sales channel for QUELIMMUNE.
Watch Nuwellis's pediatric revenue, not its equipment sales as a proxy for QUELIMMUNE demand. Growth shows that this group of hospitals is still buying Nuwellis's fluid-management systems, but does not prove they are adopting SeaStar's therapy; a decline shows weaker Nuwellis sales to these customers, while SeaStar's demand still has to be judged from its own hospital and sales figures.
SeaStar Medical Holding Corporation earningsThis company
SeaStar Medical's report will show whether more children's hospitals are using QUELIMMUNE and turning its limited product sales into a growing source of revenue.
Read QUELIMMUNE sales alongside the number of hospitals buying it. If both rise, hospital adoption is widening and product revenue is building a firmer base. If sales or the buyer count stalls or falls, commercialization remains limited and is unlikely to ease SeaStar's reliance on external funding.
