SeaStar Medical Holding Corporation
ICU evidence brief
What we can confirm
- BioSniper Score:
- 7.0 / 10
- Market Cap:
- $15.6M
- Lead Asset:
- quelimmune (Approved)
What it means
What to watch
Prepared research question
What matters most for ICU—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ICU
SeaStar Medical Holding Corporation is a commercial-stage healthcare company developing the Selective Cytopheretic Device (SCD) for critically ill patients with hyperinflammatory conditions, with a marketed pediatric product (QUELIMMUNE) and a pivotal adult trial underway.
Key risk: Need for additional capital
BioSniper Score
Based on 4 of 6 signals
Market Cap
$15.6M
Cash Runway
—
Lead Asset
quelimmune (Approved)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 3 clinical trials for SeaStar Medical Holding Corporation.
SeaStar Medical Holding Corporation is a commercial-stage healthcare company developing the Selective Cytopheretic Device (SCD) for critically ill patients with hyperinflammatory conditions, with a marketed pediatric product (QUELIMMUNE) and a pivotal adult trial underway.
- Commercial-stage company focused on the Selective Cytopheretic Device (SCD) for hyperinflammation and organ failure [sec_mda · as of 2026-05-13].
- QUELIMMUNE, the pediatric SCD for acute kidney injury, is commercially available and added top-rated children's hospitals in Q1 2026 [news · published 2026-05-13].
- Pivotal NEUTRALIZE-AKI trial for adult SCD is enrolling; topline results and PMA submission anticipated in 2027 [sec_mda · as of 2026-08-12].
- Total revenue of $0.6M and net loss of $3.7M for the six months ended June 30, 2026 [sec].
- Expects to need additional funding to support clinical development and commercialization; may delay or reduce programs if capital is insufficient [sec_mda · as of 2026-08-12].
What works
- First-in-class SCD therapy addresses a large potential market of over one million patients annually with life-threatening hyperinflammatory conditions [sec_mda · as of 2026-08-12].
- QUELIMMUNE is already generating revenue and expanding its hospital customer base, with Q1 2026 revenue up 69% year-over-year [news · published 2026-05-13].
- Multiple Breakthrough Device Designations from the FDA are expected to expedite clinical development and regulatory review [sec_mda · as of 2026-08-12].
- Experienced senior management and scientific advisory team with expertise in regulatory, medical affairs, and commercialization [sec_mda · as of 2026-08-12].
What to weigh
- Company has a history of net losses and expects to incur significant expenses; revenue is still minimal and fluctuates quarter to quarter [sec_mda · as of 2026-08-12].
- Substantial additional capital is required; if not obtained, the company may be forced to delay or cease R&D and commercialization efforts [sec_mda · as of 2026-08-12].
- Adult SCD is still in pivotal trials and has not yet received FDA approval; failure to obtain approval would materially harm future revenue prospects [sec_mda · as of 2026-08-12].
- Dependence on warrant exercise and equity line of credit for liquidity, with no guarantee of proceeds [sec_mda · as of 2026-08-12].
From the filings
Quoted directly from source documents.
Company is a commercial-stage healthcare company focused on hyperinflammation and organ failure.
“We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.”
SEC MD&A · May 13, 2026
QUELIMMUNE revenue grew 69% year-over-year in Q1 2026.
“Added 7 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing first quarter revenue 69% versus first quarter 2025 revenue”
News · May 13, 2026
Adult SCD pivotal trial topline results and PMA submission expected in 2027.
“We anticipate reporting topline clinical trial results and, assuming a successful trial outcome, submission of a Pre-market Approval ("PMA") application in 2027.”
SEC MD&A · August 12, 2026
Company will need additional funding and may have to delay programs if capital is unavailable.
“If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs and any future commercialization efforts”
SEC MD&A · August 12, 2026
Risks & what to watch (4)›
Key risks
- Need for additional capital — Company expects to need significant funding; if unavailable, may delay or cease R&D and commercialization [sec_mda · as of 2026-08-12].
- Adult SCD regulatory approval — Adult SCD is in pivotal trials; failure to obtain FDA approval would materially harm future revenue [sec_mda · as of 2026-08-12].
- Limited revenue base — Revenue is minimal and fluctuates; company is still dependent on external financing [sec_mda · as of 2026-08-12].
- Dependence on warrant exercise — Liquidity projections may rely on uncertain warrant exercise proceeds [sec_mda · as of 2026-08-12].
What to watch
- Enrollment progress and topline results from the NEUTRALIZE-AKI pivotal adult SCD trial, expected in 2027 [sec_mda · as of 2026-08-12].
- Quarterly revenue growth and hospital adoption of QUELIMMUNE [news · published 2026-05-13].
- Any financing events, including warrant exercises or equity line draws [sec_mda · as of 2026-08-12].
- FDA feedback and potential PMA submission for adult SCD [sec_mda · as of 2026-08-12].
Sources: News · SEC MD&A · Generated October 9, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 1.01
Lead: Approved
2 candidates
No upcoming catalysts tracked
1 buy · 0 sells (180d)
Pipeline
Regulatory
Financials
Short Interest
as of May 21, 2026- % of float
- 5.5%
- Days to cover
- 1.0
- Shares short
- 217,777
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ICU short interestGovernance
Frequently asked questions
What is the AI investment thesis for SeaStar Medical Holding Corporation?
SeaStar Medical Holding Corporation is a commercial-stage healthcare company developing the Selective Cytopheretic Device (SCD) for critically ill patients with hyperinflammatory conditions, with a marketed pediatric product (QUELIMMUNE) and a pivotal adult trial underway.
What is SeaStar Medical Holding Corporation's lead drug candidate?
SeaStar Medical Holding Corporation's most advanced tracked candidate is quelimmune (Approved) for Pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy.
Who is the CEO of SeaStar Medical Holding Corporation?
Mr. Eric Schlorff is the chief executive officer of SeaStar Medical Holding Corporation (ICU).
Where is SeaStar Medical Holding Corporation headquartered?
SeaStar Medical Holding Corporation (ICU) is headquartered in Denver, CO, United States.
What therapeutic areas does SeaStar Medical Holding Corporation focus on?
SeaStar Medical Holding Corporation develops therapies across Oncology, Cardiovascular, Infectious Disease, Nephrology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.