pIPELINE
SeaStar Medical holds an exclusive, worldwide, license to commercialize the SCD in human therapeutics.
SCD granted Breakthrough Device Designations for 3 different indications:
1. Adult AKI on CKRT
2. Cardiorenal Syndrome
3. Hepatorenal Syndrome
Adult AKI on CKRT
NEUTRALIZE-AKI Study
SeaStar Medical is now conducting the NEUTRALIZE-AKI Study to assess the safety & efficacy of the SCD in critically ill adults with AKI requiring CKRT. 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.
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.