pIPELINE

SeaStar Medical holds an exclusive, worldwide license to commercialize the SCD in human therapeutics.

Approved Products:

for more information on quelimmune

The SCD has been granted Breakthrough Device Designations (BDD) for 4 indications:

1. Adult Acute Kidney Injury (AKI) on Continuous Renal Replacement Therapy (CRRT)
2. Cardiorenal Syndrome (CRS) in Congestive Heart Failure (LVAD)
3. Hepatorenal Syndrome (HRS)
4. Chronic Systemic Inflammation in End-Stage Renal Disease (ESRD) in Patients on Chronic Hemodialysis

Adult AKI on CRRT

SeaStar Medical is now conducting the NEUTRALIZE-AKI Trial to assess the safety & efficacy of the SCD in critically ill adults with AKI requiring CRRT.  The study will assess the effect of SCD treatment on various measures of patient clinical outcomes and evaluate the effect of the device on patient safety in SCD treatments from the time of initiation through 1 year. 

Primary Endpoint:

  • A composite of all-cause mortality or dialysis dependency at Day 90

Secondary Endpoints include:

  • Major adverse kidney events at Day 90 (MAKE90)
  • Dialysis dependence at 1 year
  • ICU-free days in first 28 days
  • Mortality at Day 28

For more information, visit www.clinicaltrials.gov (ID #: NCT05758077)

Read more about the clinical trial design here.

Cardiorenal Syndrome

 

In September 2023, US FDA granted SeaStar Medical a Breakthrough Device Designation for the selective cytopheretic device (SCD) for use in ICU patients with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

In addition to preclinical data, SeaStar Medical’s Breakthrough Device submission included a first-in-human study under a National Institutes of Health (NIH) grant to the University of Michigan under which a patient with severe chronic heart failure who was ineligible for heart transplantation or LVAD implantation was treated with the SCD.  The patient achieved the primary endpoint of a successful LVAD implantation and was discharged to home. Additionally, the procedure was safe and there were no SCD-related serious adverse events (SAEs).  Read more here.

In April 2024, SeaStar announced a $3.6 million NIH grant award to study the SCD in adult patients with severe chronic heart failure.  

Hepatorenal Syndrome

In October 2023, US FDA granted SeaStar Medical a Breakthrough Device Designation for the selective cytopheretic device (SCD) for use in ICU patients with acute kidney injury (AKI) and acute on chronic liver failure. This represents the third Breakthrough Device Designation granted by FDA to SeaStar Medical for the SCD device.

An investigator-initiated pilot study conducted at the University of Michigan assessed treatment with the SCD in two patients with type 1 hepatorenal syndrome. Positive clinical outcomes were seen in both cases – one patient with hepatorenal syndrome due to acute alcoholic hepatitis was alive at day 90 after seven days of SCD treatment and undergoing liver transplantation evaluation, and the other patient with hepatorenal syndrome due to non-alcoholic steatohepatitis or NASH had a successful liver transplantation 6 days after SCD therapy ended. This suggested a role of SCD immunomodulation to treat acute on chronic liver failure, regardless of the etiology, as a bridge to evaluation or successful intervention for liver transplantation. Both of these cases were recently published in the American Society for Artificial Internal Organs journal in August 2023.

Chronic Systemic Inflammation in ESRD Patients on Chronic Hemodialysis

In November 2024, US FDA granted SeaStar Medical a Breakthrough Device Designation (BDD) for the selective cytopheretic device (SCD) to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis.  Approximately 500,000 people in the US with ESRD are treated by in-center hemodialysis at least three times per week at a cost of approximately $100,000 per patient per year.  This represents the first Breakthrough designation for the SCD in a chronic indication.  Patients with ESRD face an unacceptably high disease burden, including chronic fatigue, malnutrition, repeat hospitalizations, and a 42% 5-year survival.  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 that could improve clinical outcomes.