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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 ·  11/13 17:18

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On November 13, 2024, SeaStar Medical Holding Corporation, a medical device company listed on Nasdaq under the symbol ICU, reported its financial results for the third quarter ended September 30, 2024. The company announced its first commercial sales of QUELIMMUNE™, a pediatric device for treating acute kidney injury (AKI), which received FDA clearance in February 2024. SeaStar Medical's CEO, Eric Schlorff, highlighted the direct sales to an end-user customer and the transition to a direct sales model expected to significantly increase revenue. The company also reported on the progress of its NEUTRALIZE-AKI pivotal trial for adult AKI patients, with 59 subjects enrolled and an increase in clinical sites to 12. Additionally, SeaStar Medical received FDA Breakthrough Device Designation for the SCD in chronic dialysis...Show More
On November 13, 2024, SeaStar Medical Holding Corporation, a medical device company listed on Nasdaq under the symbol ICU, reported its financial results for the third quarter ended September 30, 2024. The company announced its first commercial sales of QUELIMMUNE™, a pediatric device for treating acute kidney injury (AKI), which received FDA clearance in February 2024. SeaStar Medical's CEO, Eric Schlorff, highlighted the direct sales to an end-user customer and the transition to a direct sales model expected to significantly increase revenue. The company also reported on the progress of its NEUTRALIZE-AKI pivotal trial for adult AKI patients, with 59 subjects enrolled and an increase in clinical sites to 12. Additionally, SeaStar Medical received FDA Breakthrough Device Designation for the SCD in chronic dialysis, marking the fourth such designation. CFO David Green noted the elimination of over $9 million in long-term debt since the start of 2024. The financial results showed a net revenue of $67,500 for the quarter, with R&D and G&A expenses amounting to $2.3 million and $2.2 million, respectively. The net loss for the quarter was reported at $4.5 million, or $1.10 per share. As of September 30, 2024, the company had $2.1 million in cash and no long-term debt.
2024年11月13日,纳斯达克上市的医疗器械公司SeaStar Medical Holding Corporation(股票代码为ICU)发布了截至2024年9月30日的第三季度财务业绩。公司宣布了其针对急性肾损伤(AKI)儿童器械QUELIMMUNE™的首笔商业销售,该器械于2024年2月获得FDA批准。SeaStar Medical的首席执行官埃里克·施洛夫(Eric Schlorff)强调了直接销售给终端客户以及转向预计将显著增加营业收入的直接销售模式。公司还报告了其NEUTRALIZE-AKI关键试验针对成人AKI患者的进展,已招募了59名受试者,并将临床试验场所增加到12个。此外,...展开全部
2024年11月13日,纳斯达克上市的医疗器械公司SeaStar Medical Holding Corporation(股票代码为ICU)发布了截至2024年9月30日的第三季度财务业绩。公司宣布了其针对急性肾损伤(AKI)儿童器械QUELIMMUNE™的首笔商业销售,该器械于2024年2月获得FDA批准。SeaStar Medical的首席执行官埃里克·施洛夫(Eric Schlorff)强调了直接销售给终端客户以及转向预计将显著增加营业收入的直接销售模式。公司还报告了其NEUTRALIZE-AKI关键试验针对成人AKI患者的进展,已招募了59名受试者,并将临床试验场所增加到12个。此外,SeaStar Medical获得了FDA对于慢性透析SCD的突破性器械指定,标志着这是第四个此类指定。首席财务官大卫·格林(David Green)指出,自2024年初以来已清偿超过900万美元的长期债务。财务业绩显示该季度净收入为67,500美元,研发和总务支出分别为230万美元和220万美元。该季度净亏损为450万美元,每股1.10美元。截至2024年9月30日,公司现金为210万美元,无长期债务。
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