InspireMD (NSPR) Q2 2025 Earnings Call August 05, 2025 08:30 AM ET Speaker0Good morning and welcome to InspireMD's Second Quarter twenty twenty five Earnings Conference Call. As a reminder, this call is being recorded for replay purposes. Would now like to turn the call over to Marissa Bayesch from Gilmartin Group for introductory disclosures.Speaker1Thank you for joining us for the InspireMD Second Quarter twenty twenty five conference call. Joining us today from InspireMD are Marvin Slausman, Chief Execut ...

Exhibit 99.1 InspireMD Reports Second Quarter 2025 Financial Results --- Management to host investor conference call today, August 5, at 8:30am ET --- Miami, FL — August 5, 2025 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced financial and operating results for the second quarter and six months ended June 30, 2025. Recent Business Highlights: Marvin Slosman, CEO of InspireMD, commented: "Over the last few months, our team ha ...

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: June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the transition period from to Commission file number: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2123838 (State or other jurisdiction o ...

# 资本、产品与 监管 三线会师： 5 8 0 0 万美 元融资完 成 InspireMD, Inc.（纳斯达克代码：NSPR） 是一家总部位于以色列特拉维夫与美国佛罗里达迈阿密的医疗科技公司，成立于2005年，专注于血管内治疗设备的开 发、临床转化与商业推广。公司致力于以专有的MicroNet ® 微网技术为核心，打造具有卒中防护功能的下一代支架平台，覆盖颈动脉与冠状动脉介入治疗领域。 此次交易由PIPE融资和认股权证行使组成。其中， PIPE融资总额达4010万美元 ，由医疗健康领域领先投资机构OrbiMed和Marshall Wace联合领投，其他参与方包括 新老机构投资者及部分董事会成员。InspireMD同时发行超过1650万股普通股，并以每股2.42美元的价格完成了认股权证行使， 带来1790万美元的追加收入。 值得注意的是，认股权证行使的触发，直接源于CGuard Prime获得FDA PMA批准，这反映出市场对该产品商业化前景的积极判断。公司预计将于 2025年8月1日 完 成此次融资交割，所得资金将被用于销售与市场推广、研发投入、运营资本及其他日常用途，构筑美国市场的全面启动平台。 "此次交 ...

Core Viewpoint - InspireMD, Inc. has appointed Raymond W. Cohen to its Board of Directors, bringing over 40 years of experience in medical technology to enhance the company's strategic vision and operational execution [1][2]. Company Overview - InspireMD is focused on developing the CGuard® Prime carotid stent system aimed at preventing strokes, utilizing proprietary MicroNet™ mesh technology to achieve superior acute results and long-term outcomes [6]. Leadership Experience - Raymond W. Cohen has a notable track record, having co-founded Axonics, Inc., which went public in 2018 and was acquired by Boston Scientific for $3.7 billion in November 2024 [2]. - Cohen previously served as Chairman of SoniVie Ltd., which was acquired by Boston Scientific for $600 million, and has held leadership roles in various medical technology companies [3][4]. Strategic Goals - The company is shifting its focus towards the commercial launch of the CGuard Prime stent system following its recent PMA approval, with expectations of capturing market share and delivering long-term value [2][5]. - Cohen expressed confidence in InspireMD's potential to lead the U.S. carotid stent market due to its innovative approach and commitment to clinical excellence [5].

MIAMI, July 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Prime carotid stent system for the prevention of stroke, today announced the official commercial launch of the CGuard Prime carotid stent system in the U.S., following its premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA). The CGuard Prime was engineered specifically to minimize both early and late embolism risk by effectively trapping potential emboli against the arterial wal ...

Core Viewpoint - InspireMD, Inc. has received FDA premarket application approval for its CGuard Prime Carotid Stent System, marking a significant milestone in the treatment of carotid artery disease [1][3]. Group 1: FDA Approval and Clinical Evidence - The FDA approval is supported by data from the C-GUARDIANS pivotal trial, which included 316 patients across 24 sites in the U.S. and Europe, demonstrating the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates in carotid intervention studies [2][5]. - The C-GUARDIANS trial showed strong evidence of the neuro-protective benefits of the MicroNet™ mesh technology used in the CGuard Prime system, with the lowest event rates for stroke, death, and myocardial infarction reported in any carotid revascularization trial [3][6]. Group 2: Product Features and Market Impact - The CGuard Prime Carotid Stent System features a novel mesh-covered design aimed at improving patient safety through sustained embolic protection, combining a large open-cell frame with a small mesh pore size to prevent plaque protrusion [4]. - With over 65,000 implants sold and studies involving over 2,000 patients, the CGuard Prime is positioned as a proven technology for treating obstructive carotid artery disease, with plans for an immediate U.S. launch following FDA approval [3][4]. Group 3: Financial Implications - The FDA approval triggers the second of four milestone-driven warrant tranches from a private placement financing of up to $113.6 million, with gross proceeds expected to be $17.9 million if fully exercised [3]. - Proceeds from the warrant tranche will support the commercial launch of the CGuard Prime system in the U.S., regulatory pathways for advanced applications, and the development of new products [3].

Core Insights - InspireMD has received CE approval for its next-generation carotid stent, CGuard Prime, which is designed to treat carotid artery stenosis [2][4][6] - The CGuard Prime stent utilizes unique MicroNet technology to effectively reduce the risk of embolic events and strokes [4][28] - The carotid stent market is projected to grow significantly, with a forecasted value of $1.2 billion in 2024, increasing to $2.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 9.2% from 2026 to 2033 [10][12] Company Overview - InspireMD was founded in 2005 and is headquartered in Tel Aviv, Israel, focusing on the development and commercialization of its core MicroNet technology for treating vascular diseases [30] - The company went public on NASDAQ in 2011 and aims to establish a unified platform for commercialization in the carotid stent market [6][30] Product Features - CGuard Prime features a dual-layer design and SmartFit technology, which enhances the stent's adaptability to various vascular shapes and sizes, thereby improving surgical outcomes and patient recovery [14][17][19] - The MicroNet technology, made from polyethylene terephthalate (PET), effectively intercepts thrombus and plaque while maintaining blood flow, contributing to the stent's efficacy [19][28] Clinical Trials - The C-GUARDIANS IDE study, a multi-center trial, aims to evaluate the safety and efficacy of the CGuard stent in high-risk patients, with results indicating a low adverse event rate of 1.95% within 12 months post-procedure [21][25][27] - The study supports the MicroNet's protective role against neurological events, demonstrating a 100% primary patency rate within six months and no in-stent restenosis [28]

Core Points - InspireMD, Inc. has received CE Mark approval for the CGuard® Prime EPS under the European Medical Device Regulation, marking a significant milestone for the company [1][3] - The CGuard® Prime system is designed to enhance deliverability and deployment while reducing embolic events through its proprietary MicroNet™ mesh technology [2][4] - The approval paves the way for commercial launch in CE marked markets and is expected to facilitate a U.S. launch later this year, pending FDA approval [3] Company Overview - InspireMD aims to establish its MicroNet™ technology as the industry standard for carotid stenting, focusing on acute results and long-term stroke-free outcomes [5] - The CGuard Embolic Prevention System is designed for patients at high risk for surgical complications, offering a less invasive treatment option [4] - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company actively shares important investor information on its website [5]

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 ...