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8-K: Current report

SEC announcement · Apr 17 16:06

ICU -1.45% ICUCW -10.49%

Summary by Moomoo AI

On April 17, 2024, SeaStar Medical Holding Corporation, a medical device company listed on NASDAQ under the symbol ICU, released its financial results for the year ended December 31, 2023, and provided a business update. The announcement highlighted the company's first FDA approval for Quelimmune™, a device for treating acute kidney injury (AKI) and sepsis in critically ill pediatric patients. The company is actively working to commercialize Quelimmune Pediatric in U.S. children's hospitals through its distribution partner, Nuwellis. SeaStar Medical also reported on the progress of its NEUTRALIZE-AKI clinical trial for adult AKI patients, with an interim analysis expected in the second half of 2024. Additionally, the company has filed its Form 10-K for 2023, which includes restated 2022 financial statements, primarily involving non-cash items with minimal impact on operations. The financial results showed an increase in R&D and G&A expenses, contributing to a net loss of $26.2 million, or $1.21 per share. Despite the loss, the company highlighted its cash position of $176,000 as of December 31, 2023, bolstered by a $9.0 million registered direct offering earlier in the year. SeaStar Medical continues to explore additional indications for its Selective Cytopheretic Device (SCD) technology and has received Breakthrough Device Designation for the SCD in cardiorenal and hepatorenal syndromes.

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