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 Mayo Clinic is now cleared to enroll subjects in the company’s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15.
“We are thrilled to activate another large academic center to our study,” said Chief Medical Officer Kevin Chung. “Enrollment in the trial currently stands at 76 with six subjects enrolled since the first of the year. We look forward to our next major milestone of reaching our 100th subject for our interim analysis soon.”
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.
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic SCD in 200 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy.
ICU shares were down a penny to $1.74.
