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SEC EDGAR 8-KAUG 127 min read$ICU

SeaStar Medical Reports Second Quarter 2026 Financial Results and Provides Business Updates

SeaStar Medical Holding Corp (ICU) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 SeaStar Medical Reports Second Quarter 2026 Financial Results and Provides Business Updates Added 3 top-rated children ’ s hospitals to QUELIMMUNE ® pediatric acute kidney injury (AKI) customer base, increasing net revenue 82% versus second quarter 2025 Advanced enro

Original reporting
SEC EDGAR 8-K
Published Aug 12, 2026, 8:10 PM UTC
Analysis
AlphAI AI DeskAI-generated
Added to AlphAI Aug 12, 2026, 8:16 PM UTC. Informational, not investment advice.
How this was made
AlphAI summarizes source reporting and applies a structured AI analysis for relevance, timing, sentiment and ticker impact. Always verify material claims with the original publisher.
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AlphAI market briefEarnings
Primary signal
$ICU
Bullish
medium confidence
Mentioned
$ICU
Relevance
7/10
AlphAI data visualization · based on SEC EDGAR 8-K
Decision brief

The 30-second read

$ICUBullishMed
01

Why it matters

Key trading-relevant updates are QUELIMMUNE revenue growth, NEUTRALIZE-AKI enrollment progress toward 339 patients, and CMS ICD-10-PCS codes expected to take effect Oct 1, 2026, which may improve billing and adoption.

02

Market read

Investors get a fresh checkpoint on commercialization traction (QUELIMMUNE revenue), trial momentum (223/339 enrolled), and reimbursement readiness (ICD-10-PCS effective Oct 1, 2026), alongside updated loss and cash figures.

03

What to watch

Cash declined to $7.0M from $12.0M at year-end, and R&D and G&A rose, which could increase financing needs before PMA milestones.

Relevance 7/10Novelty 7/10Timing: after-hours filing today, ahead of the Aug 12 4:30pm ET earnings call

Background

This is an SEC 8-K with Exhibit 99.1 covering SeaStar Medical’s Q2 2026 financial results and business updates for QUELIMMUNE and the NEUTRALIZE-AKI pivotal trial.

Company-level read

Ticker impact

$ICUBullishMedium confidence
Context

SeaStar Medical reported Q2 2026 results and said QUELIMMUNE net revenue rose to about $0.6M, plus NEUTRALIZE-AKI enrollment reached 223 of 339.

Expected impact

Bias modestly positive, with upside skew if investors view the ICD-10-PCS rollout and trial enrollment pace as de-risking the 2027 PMA path.

Evidence & confidence

New disclosures include quarterly revenue, R&D and cash burn, trial enrollment progress (223/339), and CMS ICD-10-PCS codes expected to take effect Oct 1, 2026, all of which affect commercialization and regulatory-readiness narratives.

Market effects

Sector

Reinforces investor focus on reimbursement enablement (ICD-10-PCS) and enrollment pace as key de-risking signals for small-cap medtech/biotech.

Regional

Limited, company-specific US healthcare impact.

Global

Low, primarily US reimbursement and FDA PMA timeline driven.

Counterpoint

What could challenge this read

Revenue growth may still be too small in absolute dollars to offset dilution risk, and the adult AKI PMA timeline remains contingent on trial outcomes.

Key entities

  • issuer
    SeaStar Medical Holding Corp

    Commercial-stage healthcare company focused on organ-failure treatments; subject of the 8-K.

  • product
    QUELIMMUNE (SCD-PED)

    Selective cytopheretic device therapy being commercialized for pediatric AKI in ICU settings.

  • clinical_trial
    NEUTRALIZE-AKI

    Pivotal trial evaluating SCD therapy in adult AKI patients on continuous renal replacement therapy.

  • regulatory_billing
    CMS ICD-10-PCS codes

    Procedure coding system codes enabling standardized inpatient billing for SCD therapy, expected to take effect Oct 1, 2026.

  • regulatory_pathway
    FDA PMA application

    Planned premarket approval submission for adult AKI indication, contingent on trial outcome.

Read at source← All news

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