The Autonomous Reanimation and Evacuation (AREVA) Research Institute has been awarded a $2 million Department of Defense grant to evaluate SeaStar Medical's Selective Cytopheretic Device (SCD) therapy for treating severe burns, inhalation injury, and sepsis in military personnel. The grant represents one of only four projects selected from 160 submissions to the 2024 Military Burn Research Program, underscoring the innovative potential of this extracorporeal immunomodulation approach.
Breakthrough Military Medical Research Initiative
The three-year research study is scheduled to begin in July 2025 and will explore the application of SeaStar Medical's SCD therapy to reduce hyperinflammation in warfighters suffering from severe burns, inhalation injury, and infection. The award represents a significant advancement in extracorporeal immunomodulation technology designed to neutralize destructive hyperinflammation and improve survival rates in both combat casualties and civilian patients with severe trauma and infection.
"In my 25-year research career, this particular award and collaboration with SeaStar Medical has the potential to be one of the most impactful," said Andriy Batchinsky, MD, Principal Investigator and Founder of AREVA. "It may save the lives of large numbers of patients with infection- and trauma-related lung, kidney, and multi-organ failure."
Innovative Immunomodulation Technology
The SCD therapy functions as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that creates destructive hyperinflammation in patients' bodies. Unlike traditional pathogen removal and blood-purification tools, the SCD therapy integrates with existing continuous renal replacement therapy (CRRT) hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state while promoting activated neutrophils to become less inflammatory.
This unique immunomodulation approach is designed to support organ recovery and may reduce the need for dialysis in patients with severe acute inflammatory conditions. The therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who currently have no FDA-approved treatment options.
Clinical Significance and Research Collaboration
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, emphasized the significance of the partnership: "The AREVA Institute is one of only a handful of around the clock intensive care unit laboratories in the world capable of delivering this type of work. This DoD award represents a major vote of confidence not only for the AREVA Institute but also the potential of the SCD therapy to play a major role in the care of critically wounded service members."
The Geneva Foundation will provide research administration and operational support for the program at the AREVA Institute in San Antonio, Texas, helping accelerate innovation in military medicine. The grant funding will cover the purchase of SCD therapy devices from SeaStar Medical for use in the research study, while both organizations explore expanded applications of the technology beyond the initial investigation.
Commercial Progress and FDA Recognition
SeaStar Medical has already achieved significant regulatory milestones with its SCD technology. The company's first commercial product, QUELIMMUNE (SCD-PED), received FDA approval in 2024 and is currently the only approved therapy for pediatric acute kidney injury due to sepsis. The SCD therapy has earned six Breakthrough Device Designations from the FDA and is currently undergoing pivotal trials for adult AKI patients requiring CRRT.
The study will specifically evaluate the ability of SCD therapy to optimize functional recovery after severe burns, inhalation injuries, and infections, potentially establishing a new standard of care for critically wounded service members and civilian patients facing similar life-threatening conditions.
