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 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) 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 ...

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 ...

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 ...

MIAMI, April 30, 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 management will present at the Bank of America 2025 Healthcare Conference on Wednesday, May 14, 2025, at 1:15PM Eastern Time / 10:15AM Pacific Time. A live audio webcast and replay of the presentation may be accessed for 90 days on the “News & Events” section of the company’s website at: https://www ...

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 ...

MIAMI, March 26, 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 management will present at the 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025, at 8:00AM Eastern Time / 5:00AM Pacific Time. A live audio webcast and replay of the presentation may be accessed for 90 days on the "News & Events" section of the company's website at: https ...

Financial Data and Key Metrics Changes - CGuard revenue reached a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% growth year-over-year, with $7 million in revenue for the full year 2024, up from $6.2 million in 2023 [7][22] - Gross profit for Q4 2024 decreased by $36,000 or 7.1% to $469,000, compared to $505,000 for Q4 2023, with gross margin decreasing to 24.1% from 28.7% [19][20] - Net loss for Q4 2024 totaled $9.1 million or $0.19 per share, compared to a net loss of $5.4 million or $0.16 per share for the same period in 2023 [22] - Total operating expenses for Q4 2024 were $9.8 million, an increase of 55.8% compared to $6.3 million for Q4 2023 [20] Business Line Data and Key Metrics Changes - The company sold 3,512 CGuard stents in Q4 2024, contributing to a total of 12,100 units sold for the full year [7] - The increase in revenue was driven by growth in existing and new markets, indicating a strong commercial foundation [18][22] Market Data and Key Metrics Changes - The company estimates that more than 7,000 US TCAR procedures were performed in Q4 2024, with global unit sales close to 50% of the US-only TCAR market [8] - The anticipated US market entry of both CAS and TCAR platforms is expected to significantly expand revenue upon regulatory approval [9] Company Strategy and Development Direction - The company is focused on the anticipated approval and launch of CGuard Prime in the US, with a robust commercial and operational launch plan in place [10][11] - The new headquarters in Miami, Florida, is strategically positioned to support the US launch and commercialization of CGuard Prime [11] - The company is building a world-class commercial team and has onboarded over a dozen field sales professionals to support the launch [12] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the first half of 2025 for US approval of CGuard Prime, citing productive interactions with the FDA [34] - The company is not providing forward-looking revenue guidance but is optimistic about growth following potential FDA approval [26][27] Other Important Information - The CGUARDIANS pivotal clinical trial demonstrated a major adverse events rate of just 0.95% through 30 days and 1.95% through 12 months post-procedure, the lowest event rate reported in a pivotal study of carotid stents [13] - The company is preparing for the second tranche of financing, which would raise an additional $17.9 million upon FDA approval [14] Q&A Session Summary Question: US approval timing for CGuard Prime - Management remains optimistic about first half 2025 approval and has had productive discussions with the FDA [34] Question: CGUARDIANS II and III studies - Enrollment for CGUARDIANS II is going well, and the timeline for integration into competitor neuroprotection systems is still tracking for early 2026 [37] Question: High-level business outlook for 2025 - The international business continues to grow, and the second half of 2025 will be a foundational building time post-approval [45] Question: Commercial launch process and adoption expectations - Hospitals will not consider a product until it is approved, but the company is preparing for launch by holding places in line for VAC reviews [53] Question: Operating expenses growth in 2025 - Significant growth in operating expenses is expected due to hiring in the sales organization and ongoing clinical trials [59]