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InspireMD Inc (NSPR) 2025 Conference Transcript
NSPRInspireMD(NSPR)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 1billion,withrecentCMScoverageexpansionallowingstandardriskpatientstoaccessstentingprocedures,significantlybroadeningthemarket[7][8]4.∗∗EndovascularProceduresGrowth∗∗:Thereisanotableshiftfromopensurgerytoendovascularprocedures,withcurrentestimatesshowingaround60,000endovascularproceduresbeingperformed,splitroughlybetweenTCARandCAS[11][22]5.∗∗ClinicalData∗∗:Thecompanyhasclinicaldatafromover2,000patientsandhascompletedapivotalFDAtrial,reportinga0.951 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]