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]

Core Viewpoint - InspireMD, Inc. has officially launched the CGuard Prime carotid stent system in the U.S. after receiving FDA approval, marking a significant milestone in the company's expansion efforts [1][3]. Product Overview - The CGuard Prime is designed to minimize embolism risk by trapping potential emboli against the arterial wall while maintaining external carotid artery perfusion [2]. - Key features include a dual layer design with the largest open-cell frame and the smallest mesh pore size, a MicroNet™ bio-stable mesh made from a single 20 μm Polyethylene Terephthalate (PET) strand, and SmartFit™ technology for precise vessel wall apposition [2][4]. Market Position and Strategy - InspireMD has secured double-digit market share in over 30 countries and is prepared for a robust U.S. launch backed by a skilled commercial team [3]. - The company aims to establish its MicroNet mesh technology as the industry standard for carotid stenting, focusing on acute results and long-term stroke-free outcomes [5].

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]

Core Insights - InspireMD, Inc. has appointed Michael Lawless as Chief Financial Officer, effective on or prior to June 30, 2025, succeeding Craig Shore who has held the position for nearly 15 years [1][3] Company Overview - InspireMD is focused on developing the CGuard™ Prime carotid stent system aimed at treating carotid artery disease and preventing strokes [1][7] - The company aims to establish its proprietary MicroNet technology as the industry standard for carotid stenting, emphasizing outstanding acute results and durable, stroke-free long-term outcomes [7] Leadership Transition - Michael Lawless brings extensive experience as a public company CFO, having served as CFO of Lifeward and previously the $200 million Life Sciences unit of Brooks Automation [2] - The CEO of InspireMD expressed enthusiasm for Lawless's expertise to lead the company’s growth, particularly with the upcoming launch of CGuard Prime in the U.S. market [3] Inducement Grant Details - As part of his appointment, Lawless will receive 465,000 shares of restricted stock and stock options to purchase 212,000 shares of common stock, approved by the Compensation Committee [4] - The stock options will vest over three years, with one-third vesting on the first anniversary and the remainder in two equal installments on the second and third anniversaries, contingent on continuous employment [5]

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]

Financial Data and Key Metrics Changes - CGuard revenue reached $1,530,000, reflecting a 1.2% growth year over year [6][22] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [22] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 compared to Q1 2024 [22] - Net loss for Q1 2025 totaled $11,166,000 or $0.22 per share, compared to a net loss of $7,032,000 or $0.21 per share in the same period in 2024 [24] Business Line Data and Key Metrics Changes - CGuard stents sold totaled 2,611 units in Q1 2025, contributing to a total of approximately 64,000 implants sold to date [6][7] - Anticipated U.S. approval and launch of CGuard Prime is expected in Q3 2025, with preparations underway for a significant demand [7][10] Market Data and Key Metrics Changes - The market for carotid artery procedures is shifting from surgery to stenting, with endovascular procedures expected to represent the majority by next year [9] - The introduction of CGuard Prime is anticipated to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales volume [9] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, with a commitment to scaling U.S. operations [10][13] - A state-of-the-art facility in Miami, Florida, is expected to enhance domestic production and meet market demand efficiently [13] - The company is building a differentiated comprehensive solution for carotid revascularization, aiming to reshape the market and drive long-term growth [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for CGuard Prime and highlighted the importance of building in additional time for the approval process [31][32] - The company remains optimistic about the clinical pipeline, with strong enrollment in the CGuardians two pivotal study and a focus on advancing the TCAR strategy [16][20] Other Important Information - The company has successfully enrolled the first four patients in a tandem lesion early feasibility study, reflecting its commitment to the neurovascular community [19] - Receipt of premarket approval from the FDA would trigger additional financing tranches, supporting the company's growth strategy [20][21] Q&A Session Summary Question: Update on CGuard Prime FDA approval timeline - Management explained that the timeline was adjusted due to the scheduling of the facility site audit and the need for additional feedback from the FDA [30][31] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive [34] Question: Update on Switchgard and FDA engagement - The company has resubmitted its IDE to the FDA, with a revised timeline for clearance expected in late 2026 [37] Question: Impact of FDA changes on review team and timelines - Management confirmed that the review team remains intact and interactions with the FDA are positive, despite some delays [42][43] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval, ensuring a strong foundation is in place for the product launch [46][48] Question: Expectations for the CREST two trial results - Management indicated that the results will depend on the severity of the enrolled patients, with expectations that it may not change current practices significantly [54]

Financial Data and Key Metrics Changes - CGuard revenue reached $1,530,000, reflecting a 1.2% growth year over year [5] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [21] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 compared to Q1 2024 [21] - Net loss for Q1 2025 totaled $11,166,000 or $0.22 per share, compared to a net loss of $7,032,000 or $0.21 per share in the same period in 2024 [23] Business Line Data and Key Metrics Changes - CGuard stents sold totaled 2,611 units in Q1 2025, contributing to a total of approximately 64,000 implants sold to date [5][6] - Anticipated U.S. approval and launch of CGuard Prime expected in Q3 2025, with preparations underway for significant demand [6][9] Market Data and Key Metrics Changes - The market for carotid artery procedures is shifting from surgery to stenting, with endovascular procedures expected to dominate in the near future [8] - The introduction of CGuard Prime is expected to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales benchmarks [8] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, with a commitment to scaling U.S. operations [9][12] - A state-of-the-art facility in Miami, Florida is being established to support domestic production and meet market demand efficiently [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for CGuard Prime and highlighted the importance of building in additional time for the approval process [30] - The company remains optimistic about the clinical pipeline, with strong enrollment in the CGuardians two pivotal study and plans for further studies [15][33] Other Important Information - The company has successfully enrolled the first four patients in a tandem lesion early feasibility study, reflecting its commitment to the neurovascular community [18] - Receipt of premarket approval from the FDA would trigger additional financing tranches, supporting the company's growth strategy [19][20] Q&A Session Summary Question: Update on CGuard Prime FDA approval timeline - Management explained that the timeline was adjusted due to the scheduling of the facility site audit and the need for additional feedback from the FDA [30] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive [33] Question: Update on Switchgard and FDA engagement - The company has resubmitted its IDE to the FDA, with a revised timeline for clearance expected in late 2026 [36] Question: Impact of FDA changes on review team and timelines - Management confirmed that interactions with the FDA remain consistent, despite some disruptions, and they are confident in their submission [41] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval but remains confident in the current team's foundation [44][46] Question: Expectations for the CREST two trial results - Management indicated that the results will depend on the severity of the enrolled patients, with expectations that it may not change current practices significantly [51]

Financial Data and Key Metrics Changes - CGuard revenue for Q1 2025 reached $1,530,000, reflecting a 1.2% year-over-year growth [5][21] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [21] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 in Q1 2025 compared to Q1 2024 [21] - Net loss for Q1 2025 totaled $11,166,000 or $0.22 per share, compared to a net loss of $7,032,000 or $0.21 per share in the same period in 2024 [21] Business Line Data and Key Metrics Changes - CGuard stent sales totaled 2,611 units in Q1 2025, contributing to a total of approximately 64,000 implants sold to date [5][6] - Anticipated U.S. approval and launch of CGuard Prime is expected in Q3 2025, with preparations underway for a significant demand [6][7] Market Data and Key Metrics Changes - The U.S. market for carotid artery disease treatments is shifting towards endovascular procedures, with a significant conversion from surgery to stenting expected [8][12] - The introduction of CGuard Prime is anticipated to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales benchmarks [8][12] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, aiming for robust growth driven by the launch of CGuard Prime and the Switchgard neuroprotection system [9][19] - A state-of-the-art facility in Miami, Florida, is being established to support U.S. operations and meet market demand efficiently [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for CGuard Prime and highlighted the importance of building a strong commercial team to support the launch [6][30] - The company remains engaged with the FDA and is optimistic about the approval timeline, despite some delays due to agency processes [30][40] Other Important Information - The company has received FDA approval for the investigational device exemption for the CGuardians two pivotal study, with strong enrollment progress [16][33] - The company is also advancing its TCAR strategy with plans for a fully integrated TCAR solution, anticipating FDA clearance in late 2026 [17][36] Q&A Session Summary Question: Update on CGuard Prime FDA approval timeline - Management explained that the timeline was adjusted due to the scheduling of the facility site audit and subsequent feedback from the FDA, but they remain confident in achieving approval [30][40] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive regarding the use of CGuard Prime [33] Question: Update on Switchgard and FDA engagement - The company has resubmitted its IDE to the FDA, with a revised timeline for clearance expected in late 2026 [36] Question: Impact of FDA changes on review team and timelines - Management confirmed that the review team remains intact and interactions with the FDA are positive, despite some delays [40] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval, ensuring a strong foundation is in place for the product launch [44] Question: Expectations for CREST two trial results - Management indicated that the results will depend on the severity of the enrolled patients, with expectations that it may not change current practices significantly [52]