SeaStar Medical Holding Corp

SeaStar Medical Holding Corp is a U.S.-based medical device company focused on therapies that treat acute and chronic kidney injury through selective cytopheretic devices. Its commercial product, QUELIMMUNE, is used in pediatric patients, while the company also develops an adult SCD program and next-generation device candidates.

95,7 %

−984,6 %

+814,1 %

3.63

3.61

— SeaStar Medical Holding Corp
%
Commercial medical devices60% Commercialized QUELIMMUNE devices sold for pediatric use in hospital settings.
Clinical-stage device development30% Adult SCD and next-generation SCD programs under clinical and regulatory development.
Grants and collaboration revenue10% Government grants and potential partner payments that support research and development.

SeaStar Medical sells primarily to pediatric hospital customers that use QUELIMMUNE in clinical care settings...

  • Pediatric hospital customersprimary

    Hospitals and pediatric care centers buying QUELIMMUNE for treated pediatric patients.

  • Clinical trial and research partnerssecondary

    Sites and institutions supporting adult SCD studies and regulatory development.

  • Government and grant providerssecondary

    Public and other grant sources funding research, development, and operations.

  • Potential collaboration partnersemerging

    Companies or institutions that may provide license, collaboration, or strategic payments.

SeaStar Medical is headquartered in the United States and its reported commercial activity is centered there...

  • •United States is the core operating and commercial market
  • •FDA approval and HDE status are central to U.S. commercialization
  • •Hospital sales are currently concentrated in U.S. pediatric sites
  • •Clinical development is managed through U.S.-based trial activity
  • •No country-level revenue split was disclosed in the excerpts

The company’s near-term strategy is to expand QUELIMMUNE adoption in pediatric hospitals and build a repeatable...

01
Commercialize QUELIMMUNE in pediatric hospitalsshort-term

Commercial sales are the first scalable product revenue source.

02
Advance adult SCD regulatory developmentmedium-term

Adult approval would materially expand the market beyond pediatrics.

03
Secure external funding and partnershipsshort-term

Development and commercialization require ongoing capital support.

SeaStar Medical faces substantial financing and going-concern risk because it is still building commercial revenue...

critical

Going concern and financing dependence

The company states it needs additional capital to fund operations and may need restructuring if financing is unavailable.

Scope
Operations, clinical development, and commercialization
Materiality
high
high

Regulatory approval risk

Adult SCD commercialization depends on successful clinical development and FDA approval.

Scope
Adult SCD pipeline
Materiality
high
high

Commercial rollout risk

QUELIMMUNE sales depend on hospital adoption and can fluctuate quarter to quarter.

Scope
Pediatric hospital sales
Materiality
high
high

Clinical development risk

Preclinical and pivotal trial programs are costly and may fail to demonstrate efficacy or safety.

Scope
Adult and next-generation SCD programs
Materiality
high
Revenue recognition for QUELIMMUNE sales
Affects reported revenue timing and quarterly comparability
Grant revenue recognition
Can create non-product revenue that is less repeatable
Stock-based compensation
Raises operating expenses and affects loss metrics
Going-concern and liquidity estimates
Influences financial statement presentation and risk disclosure

Waystar Holding Corp.

WAY · Services-Computer Integrated Systems Design

Sedana Medical

SEDANA.ST · Health Care

EyePoint, Inc.

EYPT · Laboratory Analytical Instruments

Zeo ScientifiX, Inc.

ZEOX · Biological Products, (No Diagnostic Substances)

Alpha Star Acquisition Corp

ALSAF · Services-Prepackaged Software

KESTRA MEDICAL TECHNOLOGIES, LTD.

KMTS · Surgical & Medical Instruments & Apparatus

: 29.4.2026