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8-K: SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update

8-K: SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update

8-K:SeaStar Medical公布2024年第三季度财务业绩并提供业务最新情况
美股SEC公告 ·  2024/11/14 06:18

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SeaStar Medical reported its first commercial revenue of $67,500 in Q3 2024 from direct QUELIMMUNE sales, following FDA clearance in February 2024. The company has transitioned to a direct sales model in October, expecting to recognize full revenue value from end-user sales going forward. Additionally, the company shipped product worth approximately $70,000 to its former distribution partner.The NEUTRALIZE-AKI pivotal trial for adult patients has enrolled 59 subjects, with three new medical centers joining in Q4, bringing the total to 12 sites. The company received its fourth FDA Breakthrough Device Designation for the SCD in chronic dialysis indication. Financial highlights include the elimination of over $9 million in long-term debt since early 2024.Q3 2024 financial results showed R&D expenses of $2.3 million and G&A expenses of $2.2 million. The net loss was $4.5 million ($1.10 per share), compared to $7.2 million ($9.02 per share) in Q3 2023. Cash position stood at $2.1 million as of September 30, 2024, bolstered by a $10 million registered direct offering in July 2024.
SeaStar Medical reported its first commercial revenue of $67,500 in Q3 2024 from direct QUELIMMUNE sales, following FDA clearance in February 2024. The company has transitioned to a direct sales model in October, expecting to recognize full revenue value from end-user sales going forward. Additionally, the company shipped product worth approximately $70,000 to its former distribution partner.The NEUTRALIZE-AKI pivotal trial for adult patients has enrolled 59 subjects, with three new medical centers joining in Q4, bringing the total to 12 sites. The company received its fourth FDA Breakthrough Device Designation for the SCD in chronic dialysis indication. Financial highlights include the elimination of over $9 million in long-term debt since early 2024.Q3 2024 financial results showed R&D expenses of $2.3 million and G&A expenses of $2.2 million. The net loss was $4.5 million ($1.10 per share), compared to $7.2 million ($9.02 per share) in Q3 2023. Cash position stood at $2.1 million as of September 30, 2024, bolstered by a $10 million registered direct offering in July 2024.
SeaStar Medical在2024年第三季度报告了其首个商业营业收入为67,500美元,来自于直接QUELIMMUNE的销售,紧随其后的是2024年2月的FDA批准。该公司于10月转向直接销售模式,预计将从最终用户销售中实现全额营业收入。此外,该公司向其前分销合作伙伴发货了约70,000美元的产品。NEUTRALIZE-AKI关键试验为成年患者招募了59名受试者,第四季度新增三家医疗中心,累计达到12个地点。该公司获得了针对慢性透析适应症的第四个FDA突破性医疗器械认可。财务亮点包括自2024年初以来消除超过900万美元的长期债务。2024年第三季度财务结果显示研发费用为230万美元,管理费用为220万美元。净亏损为450万美元(每股1.10美元),相比于2023年第三季度的720万美元(每股9.02美元)。截至2024年9月30日,现金头寸为210万美元,得益于2024年7月的1000万美元注册直接发行。
SeaStar Medical在2024年第三季度报告了其首个商业营业收入为67,500美元,来自于直接QUELIMMUNE的销售,紧随其后的是2024年2月的FDA批准。该公司于10月转向直接销售模式,预计将从最终用户销售中实现全额营业收入。此外,该公司向其前分销合作伙伴发货了约70,000美元的产品。NEUTRALIZE-AKI关键试验为成年患者招募了59名受试者,第四季度新增三家医疗中心,累计达到12个地点。该公司获得了针对慢性透析适应症的第四个FDA突破性医疗器械认可。财务亮点包括自2024年初以来消除超过900万美元的长期债务。2024年第三季度财务结果显示研发费用为230万美元,管理费用为220万美元。净亏损为450万美元(每股1.10美元),相比于2023年第三季度的720万美元(每股9.02美元)。截至2024年9月30日,现金头寸为210万美元,得益于2024年7月的1000万美元注册直接发行。

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