InspireMD(NSPR)

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InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
GlobeNewswire News Room· 2025-06-13 21:00
MIAMI, June 13, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS. CGuard® Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet™ mesh, CGuard is designed to reduce both early and la ...
InspireMD Announces Appointment of Michael Lawless as Chief Financial Officer
Globenewswire· 2025-06-04 04:05
Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)MIAMI, June 03, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced the appointment of Michael Lawless, an industry veteran, as Chief Financial Officer, effective on or prior to June 30, 2025 (the “Effective Date”). On the Effective Date, Mr. Lawless will succeed Craig Shore, who has served as Chief Financi ...
InspireMD Inc (NSPR) 2025 Conference Transcript
2025-05-15 02:15
纪要涉及的公司 InspireMD Inc (NSPR) 纪要提到的核心观点和论据 - **核心观点**:公司专注于下一代颈动脉支架技术的FDA审批和商业化,有望借助CMS覆盖范围扩大的契机,推动行业向血管内优先的标准治疗转变,实现显著增长 [3][7][8] - **论据** - **技术创新**:公司的CGuard平台是一种自膨胀颈动脉支架,其独特的Micronet网状外层设计可防止斑块通过支架支柱脱垂,从而预防术后中风,改变颈动脉血运重建的未来发展方向 [5] - **临床数据**:公司对超过2000名患者进行了研究,完成了出色的FDA试验,316名患者的关键试验显示30天主要不良事件率为0.95%,1年为1.93%,且与超过60000名美国以外患者的临床数据以及超过1000名患者的真实世界证据结果一致 [6][17][18] - **市场趋势**:美国颈动脉支架市场规模约为10亿美元,CMS于2023年10月扩大了报销范围,使所有颈动脉疾病患者都可接受支架手术,推动了市场热情和标准治疗的转变,预计今年年底血管内手术将超过开放手术 [7][8][10] - **治疗方式**:公司参与CAS和TCAR两种颈动脉支架置入方式,并适用于中风血栓切除术期间的颈动脉支架置入,可满足不同专科医生的需求 [13][14] - **资金支持**:2023年5月,公司筹集了1.13亿美元的资金,为商业发布计划提供了良好的资金保障 [27] 其他重要但是可能被忽略的内容 - 公司首席商务官Shane Gleason约20年前曾与雅培合作推出首个颈动脉支架 [3] - 公司拥有多学科委员会,成员包括血管外科医生、心脏病专家和神经外科医生等不同专科的领先医生,为公司提供指导 [14][15] - 波士顿科学完成了对Silc Road的收购,传统的支架置入方式包括经股动脉或经桡动脉途径,而TCAR是在锁骨附近进行手术切口,然后逆转血流并在短距离内置入支架 [21] - 20年前,众多大型心血管公司进入颈动脉介入领域,但由于CMS未扩大报销范围,这些公司停止了下一代技术的研发,如今CMS扩大报销范围,公司认为进入市场的时机良好 [30][31]
InspireMD(NSPR) - 2025 Q1 - Earnings Call Transcript
2025-05-09 21:32
InspireMD Inc (NSPR) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Webb Campbell - Vice PresidentMarvin Slosman - CEOCraig Shore - CFOShane Gleason - Chief Commercial Officer Conference Call Participants Adam Maeder - Managing Director & Senior Research AnalystFrank Takkinen - Senior Research Analyst Operator Good morning and welcome to InspireMD's First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are in a listen only mode. We will be facilitating a ...
InspireMD(NSPR) - 2025 Q1 - Earnings Call Transcript
2025-05-09 21:32
InspireMD Inc (NSPR) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Webb Campbell - Vice PresidentMarvin Slosman - CEOCraig Shore - CFOShane Gleason - Chief Commercial Officer Conference Call Participants Adam Maeder - Managing Director & Senior Research AnalystFrank Takkinen - Senior Research Analyst Operator Good morning and welcome to InspireMD's First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are in a listen only mode. We will be facilitating a ...
InspireMD(NSPR) - 2025 Q1 - Earnings Call Transcript
2025-05-09 21:30
InspireMD Inc (NSPR) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 Good morning and welcome to InspireMD's First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are in a listen only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Speaker1 Thank you for ...
InspireMD, Inc. (NSPR) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-09 21:15
InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -29.41%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.19, delivering a surprise of 5%.Over the last four quarters, the company has surpassed c ...
InspireMD(NSPR) - 2025 Q1 - Quarterly Results
2025-05-09 19:09
Exhibit 99.1 InspireMD Reports First Quarter 2025 Financial Results — Management to host investor conference call today, May 9, at 8:30am ET — Miami, FL — May 9, 2025 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first quarter ended March 31, 2025. Business Highlights: Marvin Slosman, CEO of InspireMD, commented: "In the first quarter we contin ...
InspireMD Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-09 19:00
Management to host investor conference call today, May 9th, at 8:30am ETMIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first quarter ended March 31, 2025. Business Highlights: Continued engagement with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application for the CGuard Prim ...
InspireMD(NSPR) - 2025 Q1 - Quarterly Report
2025-05-09 04:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer ...