SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced that its Selective Cytopheretic Device (SCD) received Breakthrough Device Designation from the FDA for treating chronic systemic inflammation in end-stage renal disease (ESRD) patients requiring chronic hemodialysis. This marks the fourth such designation for the SCD, potentially expanding the treatable patient population in the U.S. to 745,000 annually.
The SCD is designed to address the critical unmet need in ESRD patients undergoing hemodialysis, a group facing a concerning 42% five-year survival rate. The device targets the underlying cause of poor outcomes: chronic systemic inflammation driven by pro-inflammatory neutrophils and monocytes. By selectively modulating these immune cells during continuous renal replacement therapy (CRRT), the SCD aims to improve patient survival and quality of life.
Addressing Chronic Inflammation in ESRD
More than 480,000 individuals in the U.S. with ESRD receive in-center hemodialysis at least three times a week, incurring costs of approximately $100,000 per patient annually. Current interventions have been largely ineffective in improving overall outcomes for these patients, where systemic inflammation is a major driver of chronic fatigue, malnutrition, repeat hospitalizations, and reduced survival.
According to Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, initial data suggests that the SCD has the potential to address chronic systemic inflammation safely and effectively, potentially improving survival, quality of life, and other relevant clinical outcomes. The company intends to further validate these findings to make SCD therapy available for patients undergoing chronic dialysis.
How SCD Works
The SCD is a patented, cell-directed extracorporeal device that employs immunomodulating technology. Unlike traditional blood purification methods, the SCD selectively targets and transitions pro-inflammatory monocytes to a reparative state and promotes activated neutrophils to be less inflammatory. This unique approach aims to promote long-term organ recovery and potentially eliminate the need for future renal replacement therapy (RRT), including dialysis.
Benefits of Breakthrough Designation
The FDA's Breakthrough Device Designation is intended to accelerate the development and review of medical devices that offer a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. This designation provides SeaStar Medical with enhanced access to FDA resources, potentially leading to faster development timelines, priority review, and a differentiated market position.
Eric Schlorff, SeaStar Medical CEO, stated that this designation holds numerous benefits, including enhanced access to FDA resources resulting in faster development, as well as priority review by the FDA, early access to patients and the potential for differentiated market positioning. With this and the three prior Breakthrough Device Designations granted by the FDA, their addressable patient population in the U.S. has now reached at least 745,000 patients annually.
Expanding Applications
In addition to chronic dialysis, the SCD has demonstrated a measurable reduction in excessive inflammatory responses in preclinical and clinical studies across various conditions, including sepsis, acute kidney injury (AKI), hepatorenal syndrome (HRS), cardiorenal syndrome (CRS), ischemia/reperfusion injury, and acute respiratory distress syndrome (ARDS). The SCD has been awarded FDA Breakthrough Therapy Designation for four indications: Chronic Dialysis, Adult Acute Kidney Injury (AKI), Hepatorenal Syndrome (HRS), and Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD).
