The FDA has recognised the SCD with breakthrough device designation. Credit: superbeststock via Shutterstock.

SeaStar Medical has announced a significant milestone in its pivotal NEUTRALIZE-AKI trial with 51 subjects enrolled, surpassing the halfway point toward its target of 100 participants.

The milestone was necessary for an interim analysis based on the trial’s 90-day primary endpoint.

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This study is crucial in evaluating the safety and efficacy of SeaStar Medical’s selective cytopheretic device (SCD) for adults with acute kidney injury (AKI) in intensive care units (ICUs) who are receiving continuous kidney replacement therapy.

The SCD has been recognised by the US Food and Drug Administration (FDA) with a breakthrough device designation, highlighting its potential to substantially improve treatment over existing therapies for adults with AKI. The designation is based on preliminary clinical evidence.

SeaStar Medical CMO and MD Kevin Chung said: “The pace of enrolment in NEUTRALIZE-AKI has significantly accelerated from the summer lows, with the recent momentum driving us past the halfway point toward the planned interim analysis”

“We have enrolled five subjects already in October, after enrolling only three in July and three in August. This current pace is encouraging as we work to activate additional clinical trial sites.”

In addition to this progress, SeaStar Medical’s commitment to addressing AKI extends to paediatric care.

In July 2024, the company began distributing QUELIMMUNE from its SCD Paediatric brand, for children suffering from AKI and sepsis. This was followed by the FDA granting humanitarian device exemption approval for the device.

Furthermore, last month, SeaStar Medical announced that its financial position strengthened as all its interest-bearing debt had been extinguished.

The Centers for Medicare & Medicaid Services has also supported the NEUTRALIZE-AKI trial by granting Category B coverage in July 2024 for some expenses incurred by medical centres in treating Medicare or Medicaid patients participating in the study.