InspireMD (NSPR) recently announced that it has submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States.NSPR’s quest for U.S. approval of its next-generation CGuard Prime stent, which offers best-in-class clinical outcomes to treat carotid artery disease and stroke prevention, has advanced significantly with the submission of the PMA application to the FDA.Upon successful marketing approval of the CGuard Prime caro ...

PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seekin ...

InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -15.79%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.21, delivering a surprise of -40%.Over the last four quarters, the company has surpassed ...

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 cal ...

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 carot ...

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 ( ...

财务数据和关键指标变化 - 公司第一季度总收入为1,511,000美元,较2023年同期增长22% [28] - 毛利润为292,000美元,较2023年同期下降21.6%,主要由于新员工培训成本增加 [29][30] - 毛利率从2023年同期的30.1%下降至19.4% [29] - 净亏损为7,320,000美元,较2023年同期的4,256,000美元增加 [32] - 截至2024年3月31日,现金、现金等价物和有价证券为3,400万美元,较2023年12月31日的3,900万美元有所下降 [33] 各条业务线数据和关键指标变化 - CGuard产品第一季度销售额为150万美元,较2023年同期增长近22% [10] - 公司在第一季度共销售2,553支CGuard支架,较2023年同期增长25.6% [11] - 公司CGuard支架的实际使用量已超过50,000支 [11] 各个市场数据和关键指标变化 - 公司收入增长主要来自于现有市场 [28] 公司战略和发展方向及行业竞争 - 公司致力于成为主动脉粥样硬化介入治疗市场的领导者,以其最佳CGuard支架平台为核心 [9] - 公司正在推进CGuard支架在美国的上市申请,预计于2025年上半年获批并商业化 [16][18] - 公司正在开发SwitchGuard神经保护系统及配套工具包,计划于2026年上半年获批 [19][20][38][39] - 公司认为内膜剥脱术(CAS)和颈动脉支架成形术(TCAR)技术的创新以及相关报销政策的变化,将推动内科介入治疗成为主流标准 [21][22][23] 管理层对经营环境和未来前景的评论 - 公司在2023年底的势头得以延续,并推进实现成为主动脉粥样硬化介入治疗市场领导者的使命 [9] - 公司相信CGuard支架凭借其创新的MicroNet网膜技术,有望成为主动脉粥样硬化介入治疗的黄金标准 [15] - 公司认为CMS最新的支付政策变化将推动内科介入治疗的发展,公司已做好充分准备 [21][22][23] - 公司正在与多位行业专家合作,以推进CGuard和SwitchGuard产品的研发和上市 [23][24][25][26] 问答环节重要的提问和回答 问题1 **Adam Maeder 提问** 询问C-Guardians试验数据何时可以提交FDA审批 [35] **Marvin Slosman 回答** 公司采取模块化提交方式,预计将在8-9月提交最终模块给FDA,希望能在2025年上半年获批 [36] 问题2 **Adam Maeder 提问** 询问SwitchGuard和TCAR相关产品的进展情况 [37] **Marvin Slosman 回答** 公司计划CGuard Prime于2025年上半年获批,TCAR适用版本于2025年下半年获批,SwitchGuard于2026年上半年获批 [38][39] 问题3 **Adam Maeder 提问** 询问急性缺血性卒中合并颈动脉狭窄的早期可行性研究的情况 [42][43] **Marvin Slosman 回答** 该研究旨在评估CGuard Prime在急性卒中患者中的安全性和可行性,预计将于本季度开始入组,并将根据不同于常规颈动脉支架的特殊目标指标来评估结果 [43][44][45][46]