Business
SeaStar Medical Reports 2022 Financial Results and Provides a Business Update
DENVER, March 30, 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, March 30, 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, provides a business update and reports financial results for the year ended December 31, 2022. “We are focusing on executing near-term milestones that will advance our business,” said Eric Schlorff, SeaStar Medical CEO. “Our immediate efforts are aimed at raising awareness with the medical community of our cell-directed extracorporeal therapy’s potential for playing a life-saving role for critically ill patients, working with regulators to bring products to market, and ensuring we have the systems and processes in place to serve market needs.” BUSINESS UPDATE SeaStar Medical provides the following updates on its clinical programs with its patented, first-in-class Selective Cytopheretic Device (SCD), a cell-directed extracorporeal therapy, in patients with acute kidney injury (AKI): Adult Acute Kidney Injury The Company is focused on activating the first wave of U.S. medical sites in the 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 continuous kidney replacement therapy (CKRT). Approximately 6 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 dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT standard ...