SeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal Trial

DENVER, Dec. 23, 2024 (GLOBE NEWSWIRE) -- 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 a 14^th site is now activated and able to enroll subjects in the NEUTRALIZE-AKI pivotal trial. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).

“We are pleased to welcome the 14^th hospital to our trial, especially as this site has been among the top CRRT programs in the country,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “As of today, 70 of the planned 200 subjects have been enrolled, including 24 so far in the fourth quarter. We plan to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, we anticipate a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.”

“We estimate the annual U.S. total addressable market for the SCD in adult AKI at $4.7 billion to $6.3 billion. This significant market opportunity represents a highly attractive return on a clinical trial estimated to cost SeaStar Medical approximately $15 million, with some of those costs already incurred,” said Eric Schlorff, SeaStar Medical CEO. “AKI is one of several high-value indications for our SCD that we plan to pursue. As we work to increase accessibility of our therapeutic device among those afflicted with potentially life-threatening hyperinflammation, we believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.”

The 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.