SeaStar Medical Holding Corp — Form 8-K
Filed November 3, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
SeaStar Medical announced November 3, 2026 that the FDA's CBER confirmed completion of post-approval study requirements for QUELIMMUNE (SCD-PED) in pediatric sepsis-associated acute kidney injury. The SAVE Registry study showed 65.1% 90-day survival in 43 QUELIMMUNE-treated pediatric patients versus 47.5% in 196 historical control patients (P=0.043), with no device-related adverse events. The FDA decision eliminates mandatory research infrastructure requirements, enabling broader hospital adoption without SAVE Registry participation, though SeaStar will continue voluntary enrollment.
Why this rating
Regulatory milestone removes enrollment barriers for existing approved product; expands addressable market at company valued ~$7.3M. Meaningful but not transformational—product already approved; study completion is expected validation, not new indication or adult approval.
Tradability signal
NO TRADE
No trade: price $0.01 is below our $0.5 floor — spreads at this level eat any edge. (Filing arrived outside market hours — evaluated at the next open with a live quote.)
Derived from this site's own measured outcomes + live price/liquidity at analysis time. An experiment, not investment advice.
Price action (we called it positive)
before filing · preread $0.01 ▼ 4.41% | at our read · unknown $0.01 | +10 min pending | +30 min pending | +1 hr pending | +4 hrs pending |
The stock had already moved +4.62% between hitting EDGAR and our read finishing — deltas above are measured from our read.
Quotes via Yahoo Finance at capture time; for filings arriving outside market hours the clock starts at the next open. Not investment advice. How accurate are our calls? →
See more from November 3, 2026.
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