Business
SeaStar Medical Reports First Quarter 2023 Financial Results and Provides a Business Update
DENVER, May 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, May 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2023 and provides a business update. “Enrollment of the first patient in our pivotal NEUTRALIZE-AKI trial and activation of additional clinical trial sites are expected in the coming weeks. This trial is evaluating the safety and efficacy of our patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT),” said Eric Schlorff, SeaStar Medical CEO. “Following the recent receipt of a non-approvable letter, we are working with the FDA to secure a Humanitarian Device Exemption (HDE) for use of the SCD to treat critically ill children with AKI, and are now targeting approval in late 2023.” SeaStar Medical provides the following updates on its clinical programs with its patented, first-in-class SCD, a cell-directed extracorporeal therapy for hospitalized patients with AKI requiring CKRT: Adult Acute Kidney Injury The first clinical site has been activated in our pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial to evaluate the safety and effectiveness of the SCD in critically ill adults with AKI in the intensive care unit (ICU) receiving CKRT. Approximately six million cases of adult AKI are diagnosed annually in the U.S., of which approximately 200,000 require CKRT. In 2022 the SCD received FDA Breakthrough Device Designation for adult use. This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement on clinically significant endpoints over available therapies. Breakthrough therapies receive many benefits, including a commitment by the FDA to expedite development and review.The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers. The trial’s primary endpoint is a composite of 90-day mortality or dialysis depe...