Business
SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update
DENVER, Nov. 14, 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, Nov. 14, 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 and nine months ended September 30, 2023 and provides a business update. “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO. “We are addressing the remaining administrative steps outlined by the U.S. Food and Drug Administration (FDA) for approval of the Selective Cytopheretic Device Pediatric (SCD-PED) for children with acute kidney injury (AKI) and sepsis or septic condition requiring continuous kidney replacement therapy (CKRT). Preparations with our distribution partner Nuwellis are underway for commercial launch, which we expect to occur during the first quarter of 2024 following the receipt of the formal Approval Order from the FDA expected between December 2023 and January 2024. It is highly gratifying to be on the cusp of approval to bring the lifesaving benefits of our device to critically ill children. “In our pivotal trial in adults with AKI, we have activated five clinical sites and enrolled seven patients to date. We are working diligently to qualify additional medical centers to join this trial and our goal is to enroll one patient per site per month,” he added. “The addressable adult AKI population approximates 210,000 patients per year, which is about 50-times larger than the addressable pediatric AKI patient population. “We are encouraged by the recent grant of Breakthrough Device Designation for the SCD in two additional indications – cardiorenal syndrome and hepatorenal syndrome. We view these grants as the FDA’s further validation of the potential for dysregulating immune response in saving lives and improving outcomes,” Mr. Schlorff concluded. SeaStar Medical provides the following updates on its clinical programs with its patented, first-in-class SCD, a cell-directed extracorporeal therapy: Adult Acute Kidney Injury SeaStar Medical is conducting the pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial to evalua...