InspireMD Inc.

Please stand by, your program is about to begin. If you need audio assistance during today's program, please press star zero. Good morning and welcome to INSPIRE MD's first quarter 2025 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.

Thank you for joining us for the InspireMD first quarter 2025 conference call. Joining us today from InspireMD are Marvin Salzman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During this call, management will be making forward-looking statements, not historical facts, 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 reports on Form 10-K and Form 10-Q, and any updates in our current reports on Form 8-K filed with the U.S. Security 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, May 9, 2025. Except as required by law, InspireMD disclaims any intention or 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 Salzman, Chief Executive Officer. Marvin, please go ahead.

Thank you and good morning. We're pleased to welcome everyone to the call today. I'd like to start by highlighting our first quarter performance. C-Guard revenue reached $1.53 million, reflecting a 1.2% growth year over year. This revenue translates to unit sales of 2,611 C-Guard stents sold, providing world-class treatment to thousands of patients suffering from carotid artery disease. These results contribute to our growing body of real-world experience, with roughly 64,000 implants sold to date, underscoring our expertise in the space and Global Commercial Foundation as we prepare for the anticipated U.S. approval and launch of SeaGuard Prime. Turning to our SeaGuard Prime approval status, based on our latest communication with FDA, we are optimistic for approval in the third quarter of 2025. We are actively addressing feedback and remain confident in achieving this approval. Anticipating a positive outcome, we're preparing for commercial launch with a growing world-class team expecting significant demand for C-Guard Prime as the only next-generation proven carotid stent platform demonstrating best-in-class results and superior patient outcomes. To better illustrate the opportunity ahead in the U.S., using our current sales as a benchmark, during the first quarter we sold 2,611 stents internationally. Had this volume been realized in the U.S. at current market ASPs, it would have generated approximately $12 million in revenue, assuming a balanced mix of CAS and TCAR procedures. The market growth of both CAS and TCAR remains significant with data suggesting the conversion of majority of the procedures from surgery to stenting is underway with endovascular procedures potentially representing the majority sometime next year. We believe the introduction of C-Guard Prime will further catalyze this shift as it introduces true next-generation performance and results. Given this strong starting point, we are highly confident that the U.S. launch of C-Guard Prime, combined with the potential introduction of our switchguard neuroprotection system for TCAR, will serve as a powerful catalyst for significant revenue expansion following regulatory approval. We remain committed to strategically expanding our commercial and clinical foundation throughout 2025, and we believe these investments will drive robust growth over the coming years. As we continue to engage with FDA, we've been diligently building a world-class commercial and operational engine to support our highly anticipated US launch. We've onboarded and trained roughly 20 high-powered sales and marketing professionals. Our cadence will continue adding talent to the team to address what we believe to be tremendous demand from our carotid technologies. Thus far, we're thrilled by the caliber of individuals who bring extensive experience, deep relationships, and proven track records of launching new products in the vascular space. Their expertise in this field, along with their trusted connections to our customers, builds a foundation of field presence across the United States, ready to deliver results. The overwhelming interest from highly talented seasoned professionals who are eager to join our organization at this pivotal time is a clear reflection of the excitement surrounding Seaguard Prime and the broader shift taking place in carotid revascularization toward endovascular first solutions. Our sales organization will also leverage robust claims data along with their knowledge of market dynamics and relationships to inform strategic targeting and optimize opportunity capture. Our evolving data ecosystem is laying the groundwork for precision and execution. We are not just prepared for launch. We are ready to aggressively execute a comprehensive commercial launch. We firmly believe Sea Guard Prime is positioned to redefine the treatment of carotid disease and stroke prevention, and we intend to fully capitalize on the market's momentum toward less invasive solutions. We expect our state-of-the-art facility in Miami, Florida to complement our commercial build-out, illustrating our commitment to scaling U.S. operations. Domestic production will enable us to meet market demand efficiently while also providing a diversified supply chain in the face of macroeconomic uncertainty. I was able to witness the excitement of our technology firsthand a few weeks ago at the Charing Cross International Symposium in London. The focus on the carotid intervention and groundswell around our technology was palpable. With great interest at our booth, both from physicians already using C-Guard and from those who are just learning of our story and want to be involved, including prominent U.S. doctors. Additionally, there were about five hours of carotid programming plus two fully subscribed CAS hands-on workshops and a tremendous shift in focus from prior years. Contingent upon U.S. approval, we believe we are exceptionally well-positioned to meet robust demand for SeaGuard Prime. With the infrastructure, expertise, operational readiness we've built, We are confident in our ability to drive significant and sustained success in the U.S. market. Shifting to our clinical pipeline where we continue to make strong progress. As a reminder, in October 2024, we received FDA approval for our investigational device exemption or IDE application to begin the SeaGuardians 2 pivotal study of our SeaGuard Prime carotid stent system and TCAR procedures. This important study is designed to evaluate the safety and effectiveness of our novel C-Guard PrimeStent platform in a short TCAR-indicated version compatible with existing commercially available neuroprotection systems. I'm pleased to share our enrollment remains strong and growing with new sites participating and contributing, and we remain on track to achieve our clinical milestones with an anticipated first half of 2026 approval. At the same time, we are advancing our broader TCAR strategy We're engaged with FDA and our SeaGuardian III IDE submission, which will study our fully integrated TCAR solution, pairing the SeaGuard Prime 80 stent with our proprietary switchguard neuroprotection system. We anticipate approval and initiation of our study in Q3, with possible FDA clearance in late 2026, as we advance our TCAR focus with next-generation switchguard kit designs. TCAR represents a significant and growing opportunity with more than 30,000 procedures performed annually in the U.S. As we expand our clinical footprint, we're building a differentiated, comprehensive solution for carotid revascularization, one we believe can meaningfully reshape the market and drive long-term growth. Turning now to our other clinical initiatives, we're excited to announce that we have successfully enrolled the first four patients in our tandem lesion early feasibility study. This study conducted in partnership with Dr. Adnan Siddiqui and the Jacobs Institute in Buffalo, New York, focuses on evaluating C-guard prime stent in acute stroke patients with tandem lesions in conjunction with thrombectomy. As a reminder, the C-guard prime stent features a proprietary micronet mesh, which is designed to provide superior embolic protection during carotid artery stenting. We believe this study will demonstrate the safety and feasibility of using our stent in these acute stroke procedures. This investment reflects our deep commitment to the neurovascular community and underscores a critical component of our long-term growth strategy. Our ongoing focus of both CAS and TCAR technology positions us to serve the broadest physician base while also preparing us to lead as procedural reimbursement and clinical practice increasingly shift toward an endovascular first standard of care. As a reminder, receipt of premarket approval from the FDA would trigger the second of four milestone-based financing tranches pursuant to the transformational private placement of up to $113.6 million that we originally announced in May of 2023. If fully exercised, the second tranche would raise an additional $17.9 million in gross proceeds. After premarket approval, the remaining two milestones would each trigger additional tranche financings including the receipt of FDA clearance of SwitchGuard TCAR neuroprotection system, along with the TCAR indication for the C-Guard Prime stent, and the completion of four full fiscal quarters of commercial sales of C-Guard Prime in the United States, which we anticipate in the back half of 2026, pending the approvals I mentioned earlier and based on our current plans. This quarter has positioned us to hit the ground running as we move toward these transformational milestones. Now I'll turn the call over to Craig to walk through the financials. Craig?