SeaStar Medical, Inc.
SeaStar Medical is a medical technology company focused on redefining extracorporeal therapies to mitigate the effects of excessive inflammation on vital organs. Their innovative solutions, particularly the Selective Cytopheretic Device (SCD), aim to improve outcomes for critically ill patients by addressing dysregulated immune responses that can lead to severe complications such as acute kidney injury and multi-organ failure.
Industries
Nr. of Employees
small (1-50)
SeaStar Medical, Inc.
Products
Selective cytopheretic device for pediatric AKI (humanitarian device)
An inline extracorporeal cartridge intended to treat pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with acute kidney injury due to sepsis when used within a CKRT circuit; approved under a Humanitarian Device Exemption for this indication.
Selective cytopheretic device for adult AKI and other indications (investigational)
An extracorporeal immunomodulation cartridge under clinical investigation for adult acute kidney injury requiring CRRT and other indications (e.g., cardiorenal syndrome, hepatorenal syndrome, chronic systemic inflammation in ESRD).
Selective cytopheretic device for pediatric AKI (humanitarian device)
An inline extracorporeal cartridge intended to treat pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with acute kidney injury due to sepsis when used within a CKRT circuit; approved under a Humanitarian Device Exemption for this indication.
Selective cytopheretic device for adult AKI and other indications (investigational)
An extracorporeal immunomodulation cartridge under clinical investigation for adult acute kidney injury requiring CRRT and other indications (e.g., cardiorenal syndrome, hepatorenal syndrome, chronic systemic inflammation in ESRD).
Services
Clinical trial sponsorship and execution
Design and conduct of adult and pediatric clinical studies evaluating device safety and efficacy, including endpoint selection, patient follow-up, and publication of results.
Device implementation and hospital onboarding support
Assessment of clinical infrastructure compatibility, guidance for integrating the extracorporeal cartridge into existing CKRT workflows, and support for institution enrollment in surveillance registries.
Registry-based post-market surveillance (SAVE Surveillance Registry)
Collection and analysis of real-world clinical outcomes from sites using the therapy to monitor safety and effectiveness over time.
Regulatory and evidence support for device adoption
Support for regulatory pathways including Humanitarian Device Exemption submissions and engagement around Breakthrough Device Designation programs; generation of clinical evidence to support regulatory filings.
Clinical trial sponsorship and execution
Design and conduct of adult and pediatric clinical studies evaluating device safety and efficacy, including endpoint selection, patient follow-up, and publication of results.
Device implementation and hospital onboarding support
Assessment of clinical infrastructure compatibility, guidance for integrating the extracorporeal cartridge into existing CKRT workflows, and support for institution enrollment in surveillance registries.
Registry-based post-market surveillance (SAVE Surveillance Registry)
Collection and analysis of real-world clinical outcomes from sites using the therapy to monitor safety and effectiveness over time.
Regulatory and evidence support for device adoption
Support for regulatory pathways including Humanitarian Device Exemption submissions and engagement around Breakthrough Device Designation programs; generation of clinical evidence to support regulatory filings.
Expertise Areas
- Cell-directed extracorporeal therapy
- Critical care clinical trial management
- Acute kidney injury (AKI) therapeutics
- Device-based immunomodulation targeting neutrophils and monocytes
Key Technologies
- Extracorporeal cartridge-based immunomodulation
- Continuous kidney replacement therapy (CKRT) integration
- Regional citrate anticoagulation (RCA) compatibility
- Targeted modulation of neutrophils and monocytes