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8-K: BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results

8-K: BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results

8-K:BioCardia公佈2024年第三季度業務亮點和財務業績
美股SEC公告 ·  2024/11/13 16:14

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BioCardia reported Q3 2024 financial results with reduced losses as research costs declined following the completion of CardiAMP Heart Failure Trial enrollment. Net loss decreased to $1.7M from $2.6M YoY, while R&D expenses dropped to $931,000 from $1.9M. The company raised $7.2M through a public offering in September 2024.The CardiAMP Heart Failure Trial has completed its last protocol-specified follow-up visit, with data lock expected in Q4 2024 and top-line results anticipated in Q1 2025. The FDA has accepted plans for trial completion and approved protocol amendments for the confirmatory CardiAMP Heart Failure II Trial. Additionally, BioCardia has engaged with Japan's PMDA regarding potential approval based on U.S. data.The company achieved several milestones, including FDA 510(k) approval for its Morph DNA Steerable Introducer product family and progress in other clinical programs. The last patient in the CardiAMP chronic myocardial ischemia trial's open-label cohort was treated in August 2024, with primary endpoint data expected in Q1 2025.
BioCardia reported Q3 2024 financial results with reduced losses as research costs declined following the completion of CardiAMP Heart Failure Trial enrollment. Net loss decreased to $1.7M from $2.6M YoY, while R&D expenses dropped to $931,000 from $1.9M. The company raised $7.2M through a public offering in September 2024.The CardiAMP Heart Failure Trial has completed its last protocol-specified follow-up visit, with data lock expected in Q4 2024 and top-line results anticipated in Q1 2025. The FDA has accepted plans for trial completion and approved protocol amendments for the confirmatory CardiAMP Heart Failure II Trial. Additionally, BioCardia has engaged with Japan's PMDA regarding potential approval based on U.S. data.The company achieved several milestones, including FDA 510(k) approval for its Morph DNA Steerable Introducer product family and progress in other clinical programs. The last patient in the CardiAMP chronic myocardial ischemia trial's open-label cohort was treated in August 2024, with primary endpoint data expected in Q1 2025.
BioCardia發佈了2024年第三季度財務報告,隨着心力衰竭試驗入組的完成,研究成本下降,損失減少。淨虧損同比減少至170萬美元,較之前的260萬美元有所下降,而研發費用也從190萬美元降至931,000美元。該公司在2024年9月通過公開發行籌集了720萬美元。心力衰竭試驗已完成最後一次協議規定的隨訪訪問,數據鎖定預計在2024年第四季度進行,頂線結果預計在2025年第一季度發佈。美FDA已接受試驗完成計劃並批准了確認性心力衰竭II試驗的協議修訂。此外,BioCardia已與日本PMDA就基於美國數據的潛在批准進行了接洽。該公司實現了多個里程碑,包括其Morph DNA可引導導入器產品系列獲得FDA 510(k)批准以及其他臨牀項目的進展。心力衰竭慢性心肌缺血試驗開放標籤組的最後一位患者在2024年8月接受治療,主要終點數據預計在2025年第一季度發佈。
BioCardia發佈了2024年第三季度財務報告,隨着心力衰竭試驗入組的完成,研究成本下降,損失減少。淨虧損同比減少至170萬美元,較之前的260萬美元有所下降,而研發費用也從190萬美元降至931,000美元。該公司在2024年9月通過公開發行籌集了720萬美元。心力衰竭試驗已完成最後一次協議規定的隨訪訪問,數據鎖定預計在2024年第四季度進行,頂線結果預計在2025年第一季度發佈。美FDA已接受試驗完成計劃並批准了確認性心力衰竭II試驗的協議修訂。此外,BioCardia已與日本PMDA就基於美國數據的潛在批准進行了接洽。該公司實現了多個里程碑,包括其Morph DNA可引導導入器產品系列獲得FDA 510(k)批准以及其他臨牀項目的進展。心力衰竭慢性心肌缺血試驗開放標籤組的最後一位患者在2024年8月接受治療,主要終點數據預計在2025年第一季度發佈。

譯文內容由第三人軟體翻譯。


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