FDA Grants SeaStar Medical's Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome

SeaStar Medical Holding Corporation, a medical device company, has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Selective Cytopheretic Device (SCD). This designation is aimed at treating patients in the hospital intensive care unit (ICU) with acute kidney injury (AKI) and acute on chronic liver failure, marking the third such designation for the SCD device. The FDA's decision is expected to expedite the clinical development and regulatory review of the SCD for use in patients with hepatorenal syndrome, a condition characterized by a sudden deterioration of kidney function in individuals with advanced liver cirrhosis, leading to high mortality rates.

Dr. Kevin Chung, Chief Medical Officer of SeaStar Medical, highlighted the critical role the SCD could play in allowing the kidneys to recover, potentially making patients candidates for life-saving liver transplants. Without treatment, the prognosis for patients with hepatorenal syndrome is poor, with most dying within weeks of the onset of renal failure. The mortality rate for patients with severe acute on chronic liver failure with four or more organ failures at 28 days is 100%, underscoring the urgent need for effective treatments.

A pilot study conducted at the University of Michigan assessed the SCD's treatment in two patients with type 1 hepatorenal syndrome, showing positive clinical outcomes. One patient was alive at day 90 after seven days of SCD treatment and undergoing liver transplantation evaluation, while the other had a successful liver transplantation six days after SCD therapy ended. These outcomes suggest the SCD's potential in treating acute on chronic liver failure as a bridge to liver transplantation, regardless of the etiology.

Eric Schlorff, SeaStar Medical CEO, expressed gratitude for the FDA's decision, noting the SCD's potential to improve solid organ function in various conditions, including sepsis, AKI, cardiorenal syndrome, and COVID-19. The ongoing pilot study at the University of Michigan is expected to provide valuable insights for the pivotal study in this indication.

The SCD targets the most highly activated proinflammatory neutrophils and monocytes, neutralizing them in a low calcium environment and signaling the body to focus on repair. This approach represents a novel strategy in reducing the consequences of excessive inflammation on vital organs, offering hope for critically ill patients with conditions driven by hyperinflammation.