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 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 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 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 ...

Group 1: Financial Performance - InspireMD, Inc. reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.17, and compared to a loss of $0.21 per share a year ago, indicating an earnings surprise of -29.41% [1] - The company posted revenues of $1.53 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.21%, and showing a slight increase from year-ago revenues of $1.51 million [2] - Over the last four quarters, InspireMD has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Group 2: Stock Performance and Outlook - InspireMD shares have declined approximately 1.1% since the beginning of the year, while the S&P 500 has seen a decline of -3.7% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $1.93 million, and for the current fiscal year, it is -$0.79 on revenues of $8.22 million [7] - The estimate revisions trend for InspireMD is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Group 3: Industry Context - The Medical - Instruments industry, to which InspireMD belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

InspireMD First Quarter 2025 Financial Results [Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) InspireMD is advancing its commercial and operational readiness for the anticipated U.S. launch of its CGuard Prime carotid stent system, with optimism for FDA PMA approval in Q3 2025 and ongoing enrollment in the CGUARDIANS II pivotal study - The company is optimistic about receiving FDA PMA approval for the CGuard Prime carotid stent system in the U.S. during the **third quarter of 2025**[3](index=3&type=chunk)[6](index=6&type=chunk) - InspireMD has built and trained a commercial team in preparation for a potential large-scale U.S. launch following FDA approval[3](index=3&type=chunk) - Enrollment continues at an excellent pace for the CGUARDIANS II pivotal study, evaluating the CGuard Prime system for TransCarotid Artery Revascularization (TCAR) procedures[6](index=6&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) For Q1 2025, InspireMD reported a 1.2% revenue increase to $1.53 million, flat gross profit at $0.29 million, and a 52.5% surge in operating expenses to $11.75 million, widening the net loss to $11.17 million, with cash decreasing to $26.09 million [Consolidated Statements of Operations](index=1&type=section&id=Consolidated%20Statements%20of%20Operations) Revenue for Q1 2025 grew modestly by 1.2% year-over-year to $1.529 million, while gross profit was unchanged at $292,000, and operating expenses increased substantially by 52.5% to $11.752 million, leading to a higher net loss of $11.166 million Consolidated Statements of Operations Summary | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Revenues** | $1,529,000 | $1,511,000 | +1.2% | | **Gross Profit** | $292,000 | $292,000 | 0.0% | | **Total Operating Expenses** | $11,752,000 | $7,706,000 | +52.5% | | **Net Loss** | ($11,166,000) | ($7,032,000) | +58.8% | | **Net Loss Per Share** | ($0.22) | ($0.21) | +4.8% | - The slight revenue increase was attributed to the adoption of CGuard technology, partially offset by foreign exchange impacts and distributors managing inventory levels in anticipation of CGuard Prime approval in Europe[4](index=4&type=chunk) - The **52.5% increase in operating expenses** was primarily driven by higher salaries and share-based compensation related to U.S. sales force expansion, along with costs for launch preparation and recruitment[8](index=8&type=chunk) [Consolidated Balance Sheets](index=2&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's liquidity included $26.086 million in cash, cash equivalents, and marketable securities, a decrease from $34.637 million at year-end 2024, with total assets at $38.672 million and total liabilities at $10.327 million - Cash, cash equivalents, and marketable securities decreased by **$8.55 million** during the first quarter, from **$34.637 million** on December 31, 2024, to **$26.086 million** on March 31, 2025[10](index=10&type=chunk) Consolidated Balance Sheets Summary | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $12,383,000 | $18,916,000 | | **Marketable securities** | $13,703,000 | $15,721,000 | | **Total Current Assets** | $32,144,000 | $40,521,000 | | **Total Assets** | $38,672,000 | $46,807,000 | | **Total Liabilities** | $10,327,000 | $10,721,000 | | **Total Equity** | $28,345,000 | $36,086,000 | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements regarding the company's strategies, future financial performance, and expectations, including potential FDA approval and U.S. commercial launch of CGuard Prime, which are subject to numerous risks and uncertainties - The report includes statements about future events and performance which are not guarantees and are based on current assumptions[15](index=15&type=chunk) - Key risks highlighted include a history of recurring losses, the need to raise additional capital, securing regulatory approvals, market acceptance of products, and intense competition[15](index=15&type=chunk) [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) InspireMD management will host a conference call and webcast on May 9 at 8:30 a.m. ET to discuss the first-quarter 2025 financial results and provide a corporate update Conference Call Details | Detail | Information | | :--- | :--- | | **Date & Time** | Friday, May 9 at 8:30 a.m. ET | | **Domestic Dial-in** | 1-800-579-2543 | | **International Dial-in** | 1-785-424-1789 | | **Conference ID** | IMD1Q25 | | **Webcast** | [Webcast Link](https://viavid.webcasts.com/starthere.jsp?ei=1713642&tp_key=1c3c464032) |

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 ...

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 ...

Core Viewpoint - InspireMD, Inc. is set to present at the Bank of America 2025 Healthcare Conference, highlighting its focus on carotid artery disease treatment and stroke prevention through its CGuard™ Prime carotid stent system [1]. Company Overview - InspireMD, Inc. develops the CGuard™ Prime carotid stent system aimed at treating carotid artery disease and preventing strokes [1]. - The company utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing superior acute results and long-term stroke-free outcomes [2]. Event Details - The presentation at the Bank of America 2025 Healthcare Conference is scheduled for May 14, 2025, at 1:15 PM Eastern Time / 10:15 AM Pacific Time [1]. - A live audio webcast and replay of the presentation will be available for 90 days on the company's website [2].

MIAMI, April 25, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced that it will release its first quarter 2025 financial results on Friday, May 9, 2025. In conjunction with the release, InspireMD will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its financial results and recent highlights. Interested parties may access the live earn ...