Business
SeaStar Medical Reports 2023 Financial Results and Provides a Business Update
DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update. “It was exceptionally exciting to receive our first FDA approval for Quelimmune™, which is now available for treating critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis. We are proud to be the only company to develop and commercialize a therapeutic device that’s proven to save lives and decrease dialysis dependency in these extremely sick children,” said Eric Schlorff, SeaStar Medical CEO. “We are working closely with our distribution partner to commercialize Quelimmune Pediatric to leading U.S. children’s hospitals. “In our NEUTRALIZE-AKI pivotal clinical trial, which is evaluating the safety and efficacy of our Selective Cytopheretic Device (SCD) in the significantly larger adult AKI patient population, enrollment now stands at 24 subjects and we have activated six clinical trial sites. Additional sites are advancing through the on-boarding process,” he added. “We anticipate conducting an interim analysis once we have reached the 90-day primary endpoint in 100 subjects, which we expect to occur in the second half of 2024. “Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff. “The restatement primarily involved the accounting treatment of non-cash items and had minimal to no impact on our operating expenses, cash usage, cash position or future business potential. I would like to thank our finance team for their hard work in quickly completing this restatement.” SeaStar Medical provides the following updates on its commercial and development programs, and corporate activities: Pediatric Acute Kidney Injury Only about half of patients in the pediatric ICU with AKI who require kidney replacement therapy (KRT) survive, with those surviving at risk of long-term life-threatening conditions such as chronic kidney disease. Pooled analysis from two non-controlled studies, one of which was funded by the FDA Office of Orphan Products Development, showed that ch...