secwatch.observer — SEC 8-K summary
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Issuer:     SeaStar Medical Holding Corp (ICU)
CIK:        0001831868
Form:       8-K
Filed at:   2026-11-03T13:30:35+00:00
Accession:  0001437749-26-034531
Event type: regulatory
Sentiment:  positive
Materiality: 0.72
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

FDA Confirms SeaStar Medical's QUELIMMUNE SAVE Registry Fulfilled Post-Approval Requirements
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- FDA's CBER determined the QUELIMMUNE Pediatric SAVE Surveillance Registry met post-approval study requirements under the original Humanitarian Device Exemption.
- SAVE Registry data showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for KID cohorts (N=196), P=0.043.
- Registry patients showed no device-related adverse events; results were presented as a late-breaker at ASN Kidney Week 2026.
- FDA's decision lets hospitals use QUELIMMUNE without SAVE Registry research infrastructure, expanding access at centers that previously could not participate.
- CEO Eric Schlorff noted these children typically have about a 50% survival rate with traditional supportive care alone.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/0001437749-26-034531-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1831868/000143774926034531/icu20261102_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-034531

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