SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that 51 subjects have been enrolled in its NEUTRALIZE-AKI pivotal trial, passing the halfway point toward the target of 100 subjects for performing an interim analysis on the trial’s 90-day primary endpoint. The trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT).
“The pace of enrollment 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,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “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.”
SeaStar Medical’s SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.
In July 2024 SeaStar Medical began shipping the SCD Pediatric, brand named QUELIMMUNE, for pediatric patients with AKI and sepsis indications, having received Humanitarian Device Exemption (HDE) approval from the FDA earlier in the year. Also, in September 2024 the Company announced the extinguishment of all interest-bearing debt.
