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InspireMD Announces Combined Financings of $58 Million
Globenewswire· 2025-07-31 12:30
Core Insights - InspireMD, Inc. has raised approximately $58 million through a PIPE financing and warrant exercise, following the FDA's approval of its CGuard® Prime carotid stent system [1][2][3] - The PIPE financing generated gross proceeds of $40.1 million, with participation from existing and new investors, and the exercise of warrants contributed an additional $17.9 million [2][3] - The funds will be utilized for operations including sales and marketing, research and development, and general corporate purposes [4] Financing Details - The PIPE financing involved the issuance of 16,556,184 shares of common stock at a purchase price of $2.42 per share [2] - The transaction is expected to close by August 1, 2025, subject to customary conditions [3] - BofA Securities acted as the exclusive placement agent for the PIPE [4] Strategic Objectives - The CEO of InspireMD stated that the transaction strengthens the company's balance sheet and positions it for rapid commercial growth in the carotid intervention market [3] - The company aims to leverage its proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting [7]
InspireMD to Announce Second Quarter 2025 Financial Results
Globenewswire· 2025-07-22 11:00
Company Overview - InspireMD, Inc. is a developer of the CGuard Prime carotid stent system aimed at preventing strokes [1] - The company utilizes proprietary MicroNet™ mesh technology to enhance the effectiveness of its carotid stenting products [2] Financial Results Announcement - InspireMD will release its second quarter 2025 financial results on August 5, 2025 [1] - A conference call and webcast will be held at 8:30 a.m. Eastern Time to discuss the financial results and recent highlights [1] Access to Earnings Call - Interested parties can access the live earnings call via telephone or through a webcast on InspireMD's website [2] - A replay of the webinar will be available shortly after the call and archived on the company's website [2]
InspireMD Announces U.S. Commercial Launch of CGuard® Prime Carotid Stent System for the Prevention of Stroke
GlobeNewswire News Room· 2025-07-09 11:00
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 ...
InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke
Globenewswire· 2025-06-24 20:05
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].
获批CE!新一代颈动脉支架系统
思宇MedTech· 2025-06-24 09:06
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]
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 13:00
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]
InspireMD Announces Appointment of Michael Lawless as Chief Financial Officer
Globenewswire· 2025-06-03 20:05
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
2025-05-14 18:15
Summary of InspireMD Inc (NSPR) Conference Call Company Overview - **Company**: InspireMD Inc (NSPR) - **Industry**: Medical Devices, specifically focusing on carotid stenting technology Key Points and Arguments 1. **Focus on FDA Approval**: The company is currently focused on the impending FDA approval and commercialization of its next-generation carotid stent technology [3][24] 2. **Innovative Technology**: The new self-expanding carotid stent features a unique mesh outer layer called Micronet, which aims to prevent plaque from causing post-procedure strokes [5][6] 3. **Market Opportunity**: The carotid stenting market in the U.S. is approximately $1 billion, with recent CMS coverage expansion allowing standard risk patients to access stenting procedures, significantly broadening the market [7][8] 4. **Endovascular Procedures Growth**: There is a notable shift from open surgery to endovascular procedures, with current estimates showing around 60,000 endovascular procedures being performed, split roughly between TCAR and CAS [11][22] 5. **Clinical Data**: The company has clinical data from over 2,000 patients and has completed a pivotal FDA trial, reporting a 0.95% major adverse event rate at 30 days and 1.93% at one year [6][17] 6. **Real-World Evidence**: InspireMD has treated over 60,000 patients outside the U.S. and has published real-world evidence that supports the consistency of its clinical trial results [18] 7. **Multidisciplinary Approach**: The company collaborates with a board of thought-leading physicians from various specialties to guide its strategy in treating carotid disease [15] 8. **Funding and Growth Strategy**: In May 2023, InspireMD raised $113 million to support its commercial launch plan, indicating strong financial backing for future growth [27] 9. **Market Dynamics**: The company believes it is entering the market at an opportune time due to recent CMS coverage expansions, which had previously hindered growth in the carotid intervention space [31] Additional Important Information - **Transition to Commercial Viability**: InspireMD is transitioning from an invention-focused company to a commercially viable growth story, aiming to leverage its innovative products in the market [28] - **Clean Capital Structure**: The company has a clean cap table and is listed on NASDAQ under the ticker NSPR, which is favorable for attracting investors [28] - **Historical Context**: The carotid intervention market was once seen as a billion-dollar opportunity, but previous coverage limitations stunted growth until recent changes [30][31]
InspireMD(NSPR) - 2025 Q1 - Earnings Call Transcript
2025-05-09 13:32
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 13:32
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 ...