SeaStar's Quelimmune sales rise 247% to over $630,000 as pivotal kidney trial runs longer

SeaStar Medical Holding Corp reported net Quelimmune revenue of just over $630 thousand for the third quarter of 2026, a 247% increase. The company gave the figures on its earnings call on 11 November. The absolute amount is small, so the percentage rise reflects an early commercial base rather than an established revenue line.

The bigger value driver is the NEUTRALIZE-AKI pivotal trial, which tests the company's selective cytopheretic device (SCD) in adults with acute kidney injury who are on continuous renal replacement therapy. SeaStar says about 75% of the 339-patient target is enrolled and now expects enrolment to finish around mid-2027. That moves back the point at which pivotal data can be expected.

On the regulatory track, SeaStar has filed the first module of a premarket approval application with the US Food and Drug Administration. The modular route lets a manufacturer submit sections of an application in stages instead of as one package. The company also said the agency has granted Breakthrough Device Designation to SCD for sepsis-related hyperinflammation in adults.

SeaStar also reported two administrative steps tied to Quelimmune. It said the FDA has confirmed that the post-approval SAVE Registry requirement is met. It also said the Centers for Medicare & Medicaid Services has assigned ICD-10-PCS codes for procedures involving the product, which are used to record and bill hospital procedures.