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Seastar touts positive case studies with its selective cytopheretic device

Posted on by darion

Seastar’s selective cytopheretic device (SCD) improved the clinical outcomes of four critically ill pediatric and adult patients with multiple clinical conditions. Source: Irin Somsuppamongkol via Getty Images.

Seastar has published positive case studies showing that its selective cytopheretic device (SCD) improved the clinical outcomes of four critically ill children and adult patients with multiple clinical conditions.

SCD aims to modulate the immune response in critically ill patients undergoing continuous renal-renal therapy (CKRT). The device selectively targets and removes pro-inflammatory neutrophils and monocytes from the blood, reducing excessive inflammation and cytokine storms that can lead to organ failure and death.

The manuscript presents four case studies in which critically ill pediatric and adult patients with multi-organ failure treated with SCD successfully stabilized and improved their clinical status prior to stem cell or liver transplantation or left ventricular assist device implantation.

Patients must be in a relatively stable and healthy condition before they can receive a transplant or artificial organ. If there is too much inflammation in the patient’s body, it can prevent the immune system from stabilizing and organs from healing.

SCD has breakthrough device designation from the U.S. Food and Drug Administration (FDA) for adults with acute kidney injury (AKI), cardiorenal syndrome, and hepatorenal syndrome. In January 2023, SeaStar Medical entered into a licensing and distribution agreement with Nuwellis for its SCD drug for acute kidney injury (AKI) in the US.

In June 2023, the U.S. company resolved supply chain issues that impacted the sourcing of SCD tubing connector components. The company then began recruiting patients for the NEUTRALIZE-AKI trial (NCT05758077), which is evaluating whether up to ten 24-hour SCD therapies improve survival in patients with AKI requiring CKRT compared with CKRT alone. The expected completion date of the study is 2025.

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In February 2024, Seastar received FDA approval under a Humanitarian Devices Waiver for use in children weighing 10 kg or more with AKI and sepsis. Children with a septic condition requiring continuous CKRT at any time within the next 30 to 45 days will also be indicated.

Seastar Chief Medical Officer Eric Schrolff said: “This clinical development strategy is expected to pave the way for market approval of a therapeutic device that we believe has the potential to improve the quality of life of seriously ill patients and help save lives.”