Moomoo AIのまとめ
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...Show More
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.
2024年4月17日、ナスダックのシンボルICUで上場している医療機器会社であるSeaStar Medical Holding Corporationは、2023年12月31日の年間財務結果とビジネスの更新情報を発表しました。同社は、小児集中治療患者の急性腎不全（AKI）および敗血症の治療用のQuelimmune™の最初のFDA承認に焦点を当てました。同社は、その販売代理店Nuwellisを通じて、U.S.の小児病院でQuelimmune Pediatricを商業化するために積極的に取り組んでいます。SeaStar Medicalは、成人AKI患者のNEUTRALIZE-AKI臨床試験の進捗状...すべて展開
2024年4月17日、ナスダックのシンボルICUで上場している医療機器会社であるSeaStar Medical Holding Corporationは、2023年12月31日の年間財務結果とビジネスの更新情報を発表しました。同社は、小児集中治療患者の急性腎不全（AKI）および敗血症の治療用のQuelimmune™の最初のFDA承認に焦点を当てました。同社は、その販売代理店Nuwellisを通じて、U.S.の小児病院でQuelimmune Pediatricを商業化するために積極的に取り組んでいます。SeaStar Medicalは、成人AKI患者のNEUTRALIZE-AKI臨床試験の進捗状況についても報告し、2024年後半に中間分析を予定しています。加えて、同社は2023年のForm 10-Kを提出し、主にオペレーションにほとんど影響を与えない非現金アイテムを含む再計算された2022年の財務諸表を公表しました。財務結果は、研究開発費と一般管理費の増加により、株式1株当たり26.2ドルの純損失を計上しました。それにもかかわらず、同社は、2023年12月31日時点の17.6万ドルという現金ポジションに注目しました。同社は、年初に900万ドルの登録直接調達を行い、Selective Cytopheretic Device（SCD）技術の追加の適応を探求しており、SCDに関しては、心腎症候群と肝腎症候群のBreakthrough Device Designationを取得しています。
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