临床试验和监管进展 - 宣布CGuard™ Prime 颈动脉支架系统的C-GUARDIANS IDE临床试验取得积极结果,一年主要终点事件率为1.95%,为任何颈动脉支架或栓塞保护装置关键临床试验中最低[2] - 计划在本季度向FDA提交预市场批准(PMA)申请[2] - 完成CREST-2临床试验的入组,23名患者接受CGuard治疗,这是FDA允许参与该试验的唯一一种试验性器械[8] - 正在准备启动CGUARDIANS II TCAR临床试验,计划于2024年下半年开始[9] 财务数据 - 第二季度CGuard EPS收入为174万美元,同比增长5.4%,销售2,969支CGuard支架,同比增长近6%[6] - 第二季度毛利率下降至19.0%,主要由于材料和人工成本上升[13] - 第二季度净亏损790.9万美元,每股亏损0.22美元[15] - 公司总负债为88.96亿美元，较上年同期增加9.3%[39] - 公司总权益为46.76亿美元，较上年同期增加18.3%[39,40,41] - 公司发行的普通股股数为25,196,479股，较上年同期增加15.3%[39,40] - 公司发行的优先C股股数为1,718股，与上年同期持平[40] - 公司额外实收资本为283.2亿美元，较上年同期增加8.5%[40] - 公司累计亏损为236.44亿美元，较上年同期增加6.7%[40] - 公司长期租赁负债为7.86亿美元，较上年同期减少24.3%[38] - 公司员工离职福利负债为11.45亿美元，较上年同期增加5.6%[38] - 公司总长期负债为19.31亿美元，较上年同期减少9.0%[38] - 公司2024年6月30日和2023年12月31日的财务数据均来自公司季度报告[42,43] 商业合作 - 与领先的医疗器械搜索公司The Mullings Group合作,加快在美国建设世界级的运营和商业团队[7] - 通过宣布C-GUARDIANS数据全额行使1290万份H系列认股权证,获得1790万美元的毛收益[5]

- Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial – - On track to submit a Premarket Approval (PMA) application to the FDA this quarter - - Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data - -- Management to host investor conference ca ...

- Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial – - On track to submit a Premarket Approval (PMA) application to the FDA this quarter - - Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data - -- Management to host investor conference ca ...

财务表现 - 公司收入增加5.4%至173.9万美元，主要来自欧洲市场增长[115] - 毛利润下降32.6%至33.1万美元，主要由于材料和人工成本增加[116] - 毛利率下降至19.0%，主要受上述因素影响[117] 业务发展 - 完成C-GUARDIANS临床试验患者入组，预计于2024年第三季度提交上市申请[103,104] - 获得CMS扩大无症状和标准风险患者的CAS覆盖范围[107] - 以1.3827美元的行权价格全额行权了1291.41万份H系列认股权证[111] 风险因素 - 以色列与哈马斯的战争可能会对公司业务和经营产生不利影响[112] 会计信息 - 公司目前没有重大未决诉讼[149] - 公司已采用新的会计准则[145] - 公司管理层认为公司的信息披露控制和程序是有效的[146,147] - 公司报告期内内部控制未发生重大变化[148]

CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard caro ...

CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard caro ...

-Conference call and webcast to be held at 8:30 a.m. EDT- TEL AVIV, Israel, and MIAMI, July 30, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report second quarter 2024 financial results on Tuesday, August 6th, before the financial markets open.   Management will host a conference call and webcast with the investment community at 8:30 am ( ...

Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company's C-GUARDIANS pivotal trial. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Represents first of four milestone-driven warrant tranches pursuant to private placement financing of up to $113.6 million announced in May 2023. TEL AVIV, Israel and WESTIN, Fla., July 01, 2024 (GLOBE NEWSWIRE) -- InspireMD ...

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) ...

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved TEL AVIV, Israel, and MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) f ...