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SeaStar Medical reported its first commercial revenue of $68,000 in Q3 2024 following FDA approval of its pediatric SCD device in February 2024. The company posted a net loss of $4.5 million for the quarter, compared to a $7.2 million loss in Q3 2023. Operating expenses increased to $4.5 million from $2.9 million year-over-year, driven by higher R&D and administrative costs.Research and development expenses rose 115% to $2.3 million, primarily due to increased clinical trial activities for adult SCD devices and higher personnel costs. General and administrative expenses grew 18% to $2.2 million, reflecting increased professional services and settlement costs related to the Nuwellis contract termination. The company ended the quarter with $2.1 million in cash.Looking ahead, SeaStar Medical faces liquidity challenges and substantial doubt about its ability to continue as a going concern. The company is seeking additional funding through equity or debt financing to support operations and clinical development. Management noted that 59 patients have been enrolled in the pivotal trial for adult SCD as of November 2024, while commercial rollout of the pediatric device continues following first sales in July 2024.
SeaStar Medical reported its first commercial revenue of $68,000 in Q3 2024 following FDA approval of its pediatric SCD device in February 2024. The company posted a net loss of $4.5 million for the quarter, compared to a $7.2 million loss in Q3 2023. Operating expenses increased to $4.5 million from $2.9 million year-over-year, driven by higher R&D and administrative costs.Research and development expenses rose 115% to $2.3 million, primarily due to increased clinical trial activities for adult SCD devices and higher personnel costs. General and administrative expenses grew 18% to $2.2 million, reflecting increased professional services and settlement costs related to the Nuwellis contract termination. The company ended the quarter with $2.1 million in cash.Looking ahead, SeaStar Medical faces liquidity challenges and substantial doubt about its ability to continue as a going concern. The company is seeking additional funding through equity or debt financing to support operations and clinical development. Management noted that 59 patients have been enrolled in the pivotal trial for adult SCD as of November 2024, while commercial rollout of the pediatric device continues following first sales in July 2024.
SeaStar Medicalは、2024年2月に小児SCDデバイスのFDA承認を受けて、2024年第3四半期に$68,000の初めての商業売上高を報告しました。同社は、第3四半期に$720万の損失に対して、四半期のネット損失$450万を計上しました。営業費用は、前年同期比で$290万から$450万に増加し、これは主にR&Dおよび管理コストの増加によるものです。研究開発費用は115%増の$230万に達し、主に成人SCDデバイスの臨床試験活動の増加と人件費の上昇によるものです。一般管理費用は18%増の$220万に増加し、これはNuwellis契約解除に関連するプロフェッショナルサービスおよび和解...すべて展開
SeaStar Medicalは、2024年2月に小児SCDデバイスのFDA承認を受けて、2024年第3四半期に$68,000の初めての商業売上高を報告しました。同社は、第3四半期に$720万の損失に対して、四半期のネット損失$450万を計上しました。営業費用は、前年同期比で$290万から$450万に増加し、これは主にR&Dおよび管理コストの増加によるものです。研究開発費用は115%増の$230万に達し、主に成人SCDデバイスの臨床試験活動の増加と人件費の上昇によるものです。一般管理費用は18%増の$220万に増加し、これはNuwellis契約解除に関連するプロフェッショナルサービスおよび和解コストの増加を反映しています。同社は四半期末に$210万の現金を保持しています。今後、SeaStar Medicalは流動性の課題と継続企業としての能力に対する相当な疑念に直面しています。同社は、業務および臨床開発を支援するためにエクイティまたは負債ファイナンスを通じて追加資金を求めています。経営陣は、2024年11月時点で成人SCDの画期的な試験に59人の患者が登録されている一方で、小児デバイスの商業展開が2024年7月の初売上に続いて継続していることを指摘しました。
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