SeaStar Medical has announced the receipt of Breakthrough Device Designation from the US Food and Drug Administration (FDA).
This recognition was granted by the FDA’s Center for Biologics Evaluation and Research (CBER) for its patented Selective Cytopheretic Device (SCD), designed to treat chronic systemic inflammation in patients with end-stage renal disease (ESRD) undergoing chronic hemodialysis.
This marks the first Breakthrough Device Designation for the SCD in a chronic application, highlighting its potential to improve patient outcomes by targeting dysregulated immune responses. With this latest approval.
The designation is expected to facilitate accelerated development and regulatory review, providing earlier access to patients and enhancing market positioning.
Patients with ESRD endure significant health challenges, including chronic fatigue, malnutrition, frequent hospital admissions, and a five-year survival rate of only 42%. Chronic systemic inflammation is recognised as a key factor contributing to these outcomes.
Initial studies suggest that the SCD may offer a safe and effective way to address inflammation, with the potential to enhance survival rates, improve quality of life, and deliver better clinical outcomes for those undergoing chronic dialysis.
The SCD has demonstrated promising results in reducing excessive inflammatory responses and associated organ dysfunction across various preclinical and clinical studies.
These include applications in sepsis, acute kidney injury, hepatorenal syndrome, cardiorenal syndrome, and complications such as COVID-19 and type 2 diabetes.
The SCD is a patented extracorporeal device that utilises immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT). Unlike traditional pathogen-removal systems, it transitions monocytes to a reparative state and reduces the inflammatory activity of neutrophils.
This approach aims to promote long-term organ recovery and potentially eliminate the need for future renal replacement therapies, including 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
