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SeaStar Medical Holding (Nasdaq: ICU) reported its Q1 2024 financial results and provided a business update. The company anticipates initial sales of Quelimmune™ Pediatric for addressing acute kidney injury (AKI) and sepsis in children in the coming weeks, targeting a U.S. pediatric AKI patient population estimated at 4,000 annually. The company has enrolled 31 subjects in its NEUTRALIZE-AKI trial for its Selective Cytopheretic Device Adult (SCD-ADULT) for adult AKI patients. SeaStar eliminated senior secured debt, ending Q1 with $5 million in cash. R&D expenses remained steady at $1.7 million, while G&A expenses decreased to $2.3 million. However, a significant net loss of $12.7 million was reported, largely due to non-cash losses from derivative financial instruments. The company also received several Breakthrough Device Designations for its SCD technology across various conditions.
SeaStar Medical Holding (Nasdaq: ICU) has been awarded a $3.6 million NIH grant for a clinical trial to evaluate the Selective Cytopheretic Device Adult (SCD-ADULT) in patients with severe chronic heart failure (CHF). The grant aims to study SCD-ADULT as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with acute decompensated heart failure (ADHF). The company hopes this study will pave the way for FDA approval.