SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. They develop groundbreaking solutions to stop destructive hyperinflammation and cytokine storms, aiming to improve patient outcomes and save lives. Their innovative therapies, including the patented Selective Cytopheretic Device (SCD), target hyperactivated immune cells responsible for inflammation, with several indications granted Breakthrough Device Designation by the FDA. Their first commercial product, QUELIMMUNE (SCD-PED), is FDA-approved for pediatric acute kidney injury due to sepsis, and they are conducting pivotal trials for adult indications such as AKI requiring continuous renal replacement therapy.
Industries
Nr. of Employees
small (1-50)
SeaStar Medical
Products
Humanitarian-use pediatric selective cytopheretic device (SCD-PED)
An extracorporeal cartridge-based therapy intended to be used inline with CRRT/hemodialysis circuits to treat pediatric patients with acute kidney injury due to sepsis or a septic condition; approved by FDA under a humanitarian device pathway.
Humanitarian-use pediatric selective cytopheretic device (SCD-PED)
An extracorporeal cartridge-based therapy intended to be used inline with CRRT/hemodialysis circuits to treat pediatric patients with acute kidney injury due to sepsis or a septic condition; approved by FDA under a humanitarian device pathway.
Services
Clinical trial management and execution
Design and conduct of multi-center open-label, feasibility and pivotal device trials including site coordination, enrollment management, and endpoint evaluation.
Post-market surveillance registry implementation
Establishment and management of a surveillance registry to collect post-market clinical outcomes and fulfill surveillance commitments for device use.
CRO support for feasibility and investigator-initiated studies
Operational support to act as or provide clinical research organization (CRO) services for feasibility studies, including site management and study coordination.
Clinical trial management and execution
Design and conduct of multi-center open-label, feasibility and pivotal device trials including site coordination, enrollment management, and endpoint evaluation.
Post-market surveillance registry implementation
Establishment and management of a surveillance registry to collect post-market clinical outcomes and fulfill surveillance commitments for device use.
CRO support for feasibility and investigator-initiated studies
Operational support to act as or provide clinical research organization (CRO) services for feasibility studies, including site management and study coordination.
Expertise Areas
- Clinical trial design and execution (multi-center, pivotal and feasibility studies)
- Critical care and extracorporeal therapies (CRRT/dialysis integration)
- Regulatory strategy for medical devices (FDA Breakthrough Device and HDE pathways)
- Pediatric device development and humanitarian-device deployment
Key Technologies
- Extracorporeal immunomodulation
- Continuous renal replacement therapy (CRRT) integration
- Leukocyte (neutrophil/monocyte) sequestration targeting
- Extracorporeal circuit cartridge technology