InspireMD Inc.

morning and welcome to inspires md third quarter 2025 earnings conference call currently all participants are in a listen only mode we will facilitate 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 gil martin group for introductory disclosures please go ahead

Thank you for joining us for the InspireMD third quarter 2025 conference call. Joining us today from InspireMD are Marvin Slossman, Chief Executive Officer, Mike Lawless, Chief Financial Officer, and Shane Gleason, Chief Commercial Officer. During this call, management will make forward-looking statements, which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. For more information about these risks, please refer to the risks factors described in InspireMD's most recently filed periodic report on Form 10-K and Form 10-Q, or any updates in its current reports on Form 8-K filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. This call contains time-sensitive information that is accurate only as of today, November 4th, 2025. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Flossman, Chief Executive Officer.

Marvin, please go ahead. Thank you and good morning, everyone. I'm pleased to welcome you to today's call. Joining me on the line is Mike Lawless, our Chief Financial Officer, and Shane Gleason, our Chief Commercial Officer. We are dialed in live from VIVA, the Vascular Interventional Advances Conference in Las Vegas, where we're hosting many conversations on the introduction of Seagard Prime following our approval in June. I will share more on our market traction shortly, but want to start with a detailed overview of the results of the third quarter. I'm happy to share that our business is advancing with velocity and intention. In the third quarter, we reached $2.5 million in total revenue, representing year-over-year growth of 39% and sequential growth of over 40% since the last quarter. Our growth was driven by strong early momentum in the U.S. and continued demand for our C-Guard stent platform internationally. Our strong performance was a result of months of significant internal preparation, which positioned us to hit the ground running upon FDA approval. Following approval, which we received in late June, our team immediately activated our planned commercial efforts in the United States in July. When we say commercial activation, we mean a focused and deliberate effort to make sure that our device is accessible to U.S. providers and their patients who are at risk of stroke. Our team has been engaged with many physicians and hospital systems and are working through value analysis committee approvals, contract completions, and case initiation. We are building traction methodically with the goal to drive sustainable penetration and growth in the market. Demand for C-Guard Prime has been strong. As of today, we've completed more than 100 cases in the U.S., and many of these procedures were performed within some of the largest IDNs in the country. The demand and excitement for our technology reflects the foundational work we've done over the years establishing value and awareness for our best-in-class clinical results. Globally, we are now approaching 70,000 stents sold to date as the carotid interventional market shifts to a stent-first approach. We believe the established CMS reimbursement combined with our innovative protective mesh stent design evidence and real-world experience provide a pathway for us to lead the crowded market. We are equipped with high-caliber sales leadership and clinical support reflected in the remarkable progress our group has made in just a few months post-FDA approval. Their deep experience in vascular markets and established relationships with physicians and administrators combined with a best-in-class implant forms the backbone of our early and progressive success. The team is tasked with our commitment to expanding treatment to the vast patient population who could benefit from our technology. As a reminder, over 3 million people globally are diagnosed with carotid artery disease, yet only approximately 400,000 are treated annually. This massive gap in treatment leaves patients vulnerable to catastrophic stroke events. C-Guard Prime aims to redefine success for these patients and their providers by lowering the risk of strokes and other major adverse events to levels never achieved with first-generation stenting or surgery, validated with rigorous evidence, proven clinical results, reimbursement, and real-world outcomes. As I mentioned earlier, we are living the excitement of our technology firsthand here at VIVA. Today we're here in Las Vegas with many members of our team and board of directors engaging with our physician partners and champions as we continue to launch C-Guard Prime in the US. The energy of our commercial facing teams and the unmistakable momentum around endovascular intervention gives me incredible optimism for the future of our company. Before I provide a detailed update on our clinical trial work, I wanted to take a moment to welcome our new Chief Medical Officer, Dr. Peter Tsoukas. Dr. Tsoukas will oversee clinical and medical topics, further building on our best-in-class data, as well as advancing awareness of our technology stent platform to the physician community. This transformational time for crowd intervention requires continually building a world-class team and support, and Dr. Tsoukas will be a tremendous contributor to our work ahead. We're thrilled to have Dr. Tsoukas join as our CMO. Now to the clinical pipeline, a critical piece of our long-term growth strategy. We continue to advance multiple programs and clinical studies as we work to expand our reach of our technology by building clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-Guardians 2, which evaluates a short TCAR indicated version of C-Guard Prime designed to be compatible with neuroprotection systems that are already in use in the field today. I'm pleased to report that we're on track to complete enrollment by the end of the year and potential approval anticipated in mid-2026. Simultaneously, we're advancing SeaGuardians 3, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the SeaGuard Prime 80 stent with our proprietary switchguard neuroprotection system. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive, streamlined option that we believe can set a new standard in the field. We currently expect FDA clearance and launch in mid-2027. The impact of these two studies highlights the versatility and clinical value of our platform and are expected to give us extremely competitive position in TCAR, a U.S. market that already exceeds 30,000 procedures annually. We also continue to make progress on our tandem lesion early feasibility study to expand the potential use of our technology in acute stroke care. The study is being conducted in partnership with Dr. Adnan Siddiqui and the Jacobs Institute in Buffalo, New York. This study evaluates the use of C-Guard Prime in acute stroke patients with tandem lesions in conjunction with thrombectomy. I'm happy to share that enrollment is over 50% complete. It is inspiring to hear physicians' excitement for having an option to treat this critical need with our technology in a challenging patient population. Let me also mention our awareness of the upcoming CREST-2 data that's scheduled to be presented at the VEEF and SVIN meetings in the coming weeks. We believe the culmination and sharing of this data is another reminder of the advancement of awareness of carotid intervention. and the importance of decoupling categories of therapy with specific implant-based performance to demonstrate the specificity and granularity of results. Clinical outcomes have been redefined with best-in-class evidence with C-Guard implant across a large population sample of both symptomatic and asymptomatic patient cohorts measured in both short- and long-term outcomes. The baseline of nearly 70,000 implants sold and 2,000 patients studied and peer review to date speaks volumes to the validation of our exceptional results. Our strong performance in the third quarter combined with the establishment of a robust commercial foundation gives me tremendous confidence in our ability to deliver meaningful growth and value over the coming quarters and years. Now I'll turn the call over to Mike to walk us through the financials. Mike.