SeaStar Medical Holding Corp ICU
SeaStar Medical Holding Corp (Nasdaq: ICU) is a cardio-renal-metabolic medical device company. Its next catalyst on record is Adult SCD (NEUTRALIZE-AKI): Report topline pivotal results and, if successful, submit PMA application (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Adult SCD (NEUTRALIZE-AKI) — Report topline pivotal results and, if successful, submit PMA application (2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| QUELIMMUNE (pediatric SCD) | Pediatric AKI due to sepsis requiring kidney replacement therapy | device-combination | NA_NON_THERAPEUTIC |
| Adult SCD (NEUTRALIZE-AKI pivotal trial) | Adult AKI requiring CRRT | device-combination | NA_NON_THERAPEUTIC |
| SCD feasibility study in cardiorenal syndrome awaiting LVAD | Cardiorenal syndrome | device-combination | NA_NON_THERAPEUTIC |
Recent results and decisions
- Nov 3, 2026n/a FDA confirms SeaStar Medical has fulfilled post-approval study requirements for QUELIMMUNE in pediatric patients with sepsis-associated AKI.
The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption
Filing - Nov 3, 2026positive QUELIMMUNE SAVE Registry data presented at ASN Kidney Week 2026 showed 65.1% 90-day survival versus 47.5% for standard care in critically ill pediatric AKI patients.
This late-breaking presentation at ASN Kidney Week 2026 reported a clinically meaningful and statistically significant improvement in 90-day survival of 65.1% for the QUELIMMUNE (SCD-PED) patients (N=43) versus only 47.5% (P = 0.043) for patients from clinically aligned cohorts from the Kids' Inpati
Filing - Nov 3, 2026positive FDA confirms SeaStar Medical has fulfilled post-approval study requirements for QUELIMMUNE under the original Humanitarian Device Exemption approval.
The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.