SeaStar Medical Wins Breakthrough Designation for Selective Cytopheretic Device for Adults

The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to SeaStar Medical Holding Corporation’s patented, cell-directed Selective Cytopheretic Device (SCD) for treating chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis (a.k.a., chronic dialysis).

“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve patient outcomes by targeting dysregulated immune responses. With this and the three prior Breakthrough Device Designations granted by the FDA, our addressable patient population in the U.S. has now reached at least 745,000 patients annually,” SeaStar Medical CEO Eric Schlorff said. “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.”

In addition to chronic dialysis, the SCD has shown a measurable reduction in excessive inflammatory responses such as the reduction of solid organ dysfunction in various preclinical and clinical studies, 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, among others.

“Patients with ESRD face an unacceptably high disease burden to include chronic fatigue, malnutrition, repeat hospitalizations, and a 42% five-year survival. Unfortunately, interventions directed at improving overall outcomes have largely been ineffective,” SeaStar Medical Chief Medical Officer Kevin Chung, M.D., stated. “Systemic inflammation is a major driver that leads to these poor outcomes. Initial data shows that the SCD has the potential to address chronic systemic inflammation in a safe and effective manner that could improve survival, quality of life and other relevant clinical outcomes. We intend to prove this out such that concurrent SCD therapy can be made available for patients undergoing chronic dialysis.”

More than 480,000 U.S. residents with ESRD are treated by in-center hemodialysis at least three times a week at a cost of approximately $100,000 per patient annually.

The Selective Cytopheretic Device is a patented cell-directed extracorporeal product that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future RRT, including dialysis.

The SCD has been awarded FDA Breakthrough Therapy Designation for four indications, ranked by patient population: chronic dialysis, adult acute kidney injury (AKI), Hepatorenal Syndrome (HRS), and Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD).

SeaStar Medical is a commercial-stage medical technology company attempting to redefine the ways in which extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. The company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.