SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that its Selective Cytopheretic Device (SCD) has been granted Breakthrough Device Designation by the FDA's Center for Biologics Evaluation and Research (CBER). The designation is for the treatment of chronic systemic inflammation in end-stage renal disease (ESRD) patients requiring chronic hemodialysis.
This marks the fourth indication for which the SCD has received Breakthrough Device Designation. The device aims to address the significant unmet need in managing chronic inflammation, a major driver of poor outcomes in ESRD patients. More than 480,000 individuals in the U.S. with ESRD undergo in-center hemodialysis, incurring costs of approximately $100,000 per patient annually.
Addressing Unmet Needs in ESRD
According to Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, patients with ESRD face a substantial disease burden, including chronic fatigue, malnutrition, repeat hospitalizations, and a 42% five-year survival rate. He stated that current interventions have been largely ineffective in improving overall outcomes and that systemic inflammation is a key factor contributing to these poor results. Initial data suggest that the SCD has the potential to safely and effectively address chronic systemic inflammation, potentially improving survival, quality of life, and other relevant clinical outcomes.
How SCD Works
The SCD is a patented, cell-directed extracorporeal device that utilizes immunomodulating technology. It selectively targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), reducing the hyperinflammatory environment, including the cytokine storm. Unlike traditional blood-purification methods, the SCD is integrated with CRRT hemofiltration systems to modulate the immune response. It transitions proinflammatory monocytes to a reparative state and promotes a less inflammatory state in activated neutrophils. This approach aims to promote long-term organ recovery and potentially eliminate the need for future renal replacement therapy, including dialysis.
Benefits of Breakthrough Device Designation
Eric Schlorff, CEO of SeaStar Medical, highlighted the benefits of the Breakthrough Device Designation, including enhanced access to FDA resources, faster development timelines, priority review, early patient access, and the potential for differentiated market positioning. With this designation and the three prior ones, SeaStar Medical's addressable patient population in the U.S. has reached at least 745,000 patients annually.
Broader Applications of SCD
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, hepatorenal syndrome, cardiorenal syndrome, ischemia/reperfusion injury, intracerebral hemorrhage, cardiopulmonary bypass, chronic kidney disease, type 2 diabetes, acute respiratory distress syndrome, and COVID-19.
