SeaStar Medical Holding Corporation (ICU), a commercial-stage medical device company, today announced the activation of its 13th active site for 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 200 adult patients with acute kidney injury in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).
The 13th active site for the NEUTRALIZE-AKI pivotal trial to be activated is the Sentara Norfolk General Hospital in Norfolk, Virginia.
Last month, nine critically ill adult acute kidney injury (AKI) patients were enrolled in the trial, increasing the total enrollment to 65 participants.
AKI, a condition that can lead to hyperinflammation, is marked by a sudden and temporary loss of kidney function.
Eric Schlorff, SeaStar Medical CEO, said, "Given the addressable adult AKI population of approximately 210,000 patients in the U.S. each year, we estimate annual peak sales of approximately $1 billion for the SCD in this indication.
ICU closed Tuesday's trading at $2.37, down by 0.42 percent on Nasdaq.
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