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SeaStar Medical pushes NEUTRALIZE-AKI enrolment completion to mid-2027 as Quelimmune revenue climbs

🇺🇸 SeaStar Medical Holding Corp (ICU) · Thu 12 Nov 2026

The US device maker says its pivotal acute kidney injury trial is about 75% enrolled, while it advances a PMA submission and reports higher third-quarter Quelimmune sales.

SeaStar Medical Holding Corp said on its third-quarter 2026 earnings call, held on 11 November, that enrolment in the pivotal NEUTRALIZE-AKI trial is now expected to finish around mid-2027. The study is testing the company's selective cytopheretic device (SCD) therapy in adults with acute kidney injury (AKI) who are receiving continuous renal replacement therapy (CRRT).

Enrolment is about 75% complete against a target of 339 patients, according to the company. The revised timeline extends the period before the trial can be completed.

On the regulatory side, SeaStar has submitted the first module of its premarket approval (PMA) application to the US Food and Drug Administration. A modular PMA allows a manufacturer to file sections of an application in stages rather than as a single package. The company also said the FDA has granted Breakthrough Device Designation to SCD for hyperinflammation related to sepsis in adults.

Commercially, Quelimmune generated net revenue of just over $630 thousand in the quarter, up 247%. SeaStar added that the FDA has confirmed the post-approval SAVE Registry requirement is met, and that the Centers for Medicare & Medicaid Services (CMS) has assigned ICD-10-PCS codes for procedures involving Quelimmune.

What it means for your team

  • Trial timelines: the NEUTRALIZE-AKI completion estimate has moved to around mid-2027, which pushes back the point at which pivotal data can be expected.
  • Regulatory teams should note the modular PMA approach, with the first module already filed with the FDA, and the new Breakthrough Device Designation in adult sepsis-related hyperinflammation.
  • Pharmacovigilance and post-market teams: SeaStar says the FDA considers the SAVE Registry post-approval requirement met.
  • Market access: new ICD-10-PCS codes from CMS for Quelimmune procedures support coding and billing for the therapy.

Company's press release (SEC filing): SeaStar Medical Holding Corp ↗

Article written by VigiEye from the official source (SeaStar Medical Holding Corp). Claims are the company's own. AI-assisted; check the source before acting.

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