SeaStar Medical Introduces Novel Cytopheretic Device for Adults Undergoing Chronic Dialysis

SeaStar Medical Holding Corporation has launched a first-in-class, cell-directed selective cytopheretic device (SCD) to address chronic systemic inflammation in patients with end-stage renal disease (ESRD) who require long-term hemodialysis.

The SCD is a patented, cell-directed extracorporeal device that uses immunomodulating technology to target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT), helping to reduce the hyperinflammatory environment, including the cytokine storm. 

Unlike other blood-purification methods, the SCD is integrated with CRRT hemofiltration systems, specifically targeting proinflammatory monocytes and shifting them to a reparative state, while promoting neutrophils to adopt a less inflammatory profile.

This innovative immunomodulation approach could potentially support long-term organ recovery, possibly eliminating the need for future renal replacement therapy, including dialysis.

Patients with ESRD suffer from significant disease burdens, including chronic fatigue, malnutrition, repeated hospitalisations, and a 42 percnet five-year survival rate. Unfortunately, most interventions aimed at improving outcomes have been largely ineffective. 

Systemic inflammation is a key factor driving these poor outcomes. Early data suggests that the SCD could safely and effectively manage chronic systemic inflammation, improving survival, quality of life, and other relevant clinical outcomes.

In addition to chronic dialysis, the SCD has demonstrated a measurable reduction in excessive inflammatory responses in various preclinical and clinical studies, including conditions like sepsis, acute kidney injury, hepatorenal syndrome, cardiorenal syndrome, ischaemia/reperfusion injury, intracerebral hemorrhage, cardiopulmonary bypass, chronic kidney disease, type 2 diabetes, acute respiratory distress syndrome, and COVID-19.

The U.S. FDA has granted Breakthrough Device Designation for the Selective Cytopheretic Device for adults undergoing chronic dialysis.

Source: https://investors.seastarmedical.com/news/news-details/2024/FDA-Grants-Breakthrough-Device-Designation-for-SeaStar-Medicals-Selective-Cytopheretic-Device-for-Adults-Undergoing-Chronic-Dialysis/default.aspx