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InspireMD Inc.
3/18/2026
Good morning and welcome to InspireMD's fourth quarter and full year 2025 earnings conference call. Currently, all participants are in listen-only mode. We will facilitate a question-and-answer session towards the end of today's call. This call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmour & Group for introductory disclosures.
Thank you for joining us for the InspireMD fourth quarter and full year 2025 conference call. Joining us today from InspireMD are Marvin Flawson, Chief Executive Officer, and 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 risk factors described in InspireMD's most recently filed periodic report on Form 10-K and Form 10-Q, or any updates in its current report 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, March 18, 2026. 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. As I reflect on our performance over the past several quarters, I'm extremely proud of our team here at InspireMD and enthusiastic about the impact we're having on stroke prevention and the future of an endovascular standard of care, catalyzed by our breakthrough C-Guard Prime carotid stent platform. Through the C-Guardians FDA clinical trial, along with our numerous multi-year studies of our C-Guard implant, we have demonstrated unmatched clinical evidence reflected in the lowest adverse event rates and most durable stroke prevention, enabling our continued focus on achieving market leadership through a stent-first strategy. Becoming number one in this highly competitive market will require strong operational, commercial, and customer-focused excellence throughout our organization. To this end, we are focusing on operational expansion, establishing US-based production, increasing our manufacturing capacity to keep pace with this growing US demand. On the commercial side, we're building our coverage capacity and procedural support bandwidth. Since our approval in June 2025, we have architected, implemented, and now accelerated the foundational requirements to deliver commercial sales in the US market through VAC initiations and approvals, contract implementation, case completions and reorders, all building in our mission to dominate this space with our next generation stent. Thus far, we are pleased with the physician's support and pace toward these fundamental operational milestones, getting products on shelves and available to meet market demand. We met our 2025 objectives of building our U.S. commercial team to north of 30 people with the majority in the field, as we previously shared. We have now completed over 500 cases, gained approvals in some of the most prominent IDNs in the United States, and established ourselves as the go-to device for many physicians who now have access to C-Guard Prime. We remain committed to supporting the success of every procedure with strong case support and continuous improvement with ease of use of our products. As I've stated previously, we have real-world experience with the C-Guard stent in over 70,000 cases in our 30 OUS markets to date, which we're leveraging in our launch. As we have executed on our controlled rollout, we have observed opportunities to improve our delivery system's technical success and enhance ease of use. We understand what is required to exceed our customer expectations, and we plan to introduce these improvements beginning in the fourth quarter. Now to our clinical pipeline and advanced indications for our C-Guard implant, a critical piece of our long-term growth strategy. We continue to build on multiple programs and clinical studies as we work to expand the reach of our technology by leveraging clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-Guardians 2, evaluating C-Guard Prime in a shorter delivery system, purpose-built for use in TCAR procedures and designed to be compatible with neuroprotection systems that are already in use in the market. I'm pleased to report that we have completed enrollment in this trial and submitted the request for approval to FDA, anticipating potential approval in Q3. This indication will boost our market opportunity for stent sales into the more than 35,000 current TCAR procedures annually. Simultaneously, we are rapidly advancing C-Guardians 3, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the C-Guard 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 plan to begin enrollment in this study in Q2 with expected FDA clearance and launch in the second half of 2027. To recap expectations for 2026, we will deliver extraordinary quality and exceed expectations for our growing range of customers, build a sustainable foundation from which we can expand stenting market, utilize the C-Guard Stent First strategy to differentiate superior outcomes, serve the entirety of the market for all specialists treating carotid disease, boldly build a market-leading company worthy of lofty expectations from our customers and patients who benefit from our breakthrough technology. Finally, I would like to thank our entire team for their extraordinary commitment to our success, and I look forward to continuing to build our organizational strength with deep talent and expertise to advance our mission to prevent strokes and save lives. I am incredibly excited about our future and look forward to sharing our progress over the coming year. Now I'll turn the call over to Mike to walk us through the financials. Mike.
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