InspireMD Inc.

Good morning and welcome to InspireMD's second quarter 2025 earnings conference call. Currently, all participants are in a listen-only mode. We will be soliciting 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 Marissa Baich from Gil Martin Group for introductory disclosures.

Thank you for joining us for the InspireMD second quarter 2025 conference call. Joining us today from InspireMD are Marvin Clausman, Chief Executive Officer, and Mike Lawless, 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 or any other updates in our 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 August 5, 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 Slausman, Chief Executive Officer. Marvin, please go ahead.

Marvin Slausman Thank you, and good morning, everyone. We're happy to welcome you to today's call. at this exciting and transformative moment for our company. Before we review our recent progress and second quarter results, I'd like to take a moment to formally welcome Mike Lawless, our new Chief Financial Officer. Mike brings decades of financial leadership and deep expertise to InspireMD, as well as a clear commitment to our mission and to the patients we serve. I'd also like to thank Craig Shore for his contribution and dedication over the past 15 years. His impact on the company's foundation and trajectory has been invaluable and is a big part of why we're here today. Turning to our recent progress as a business, today's call comes just about a month after we received FDA pre-market approval for our Seaguard Prime carotid stent system, the most significant milestone in our company's history to date. We are now commencing on our U.S. commercial launch, leveraging our wealth of experience from over 30 OUS markets with over 60,000 patients treated to date to take the first step toward our mission of leading the US carotid interventional market. I want to take a moment to reiterate what sets us apart as we step into this immense opportunity. Our mission is clear, to transform the carotid intervention market and deliver best-in-class patient outcomes through a stent-first approach. Over 3 million people globally have been diagnosed with carotid artery disease, with countless others remaining undiagnosed, while only 155,000 are treated annually in the United States. These patients are at risk of stroke with deadly and profound debilitating outcomes. We've invested years of effort and expertise to build an innovative stent platform, C-Guard Prime, that redefines success for these patients and their providers by lowering the risk of strokes and other major adverse events to levels never achieved with stenting or surgery as validated with rigorous evidence, proven clinical results, and real-world experience. We are the first company to invest in the broadest toolkit of carotid procedures, supporting both carotid artery stenting, known as CAS, and transcarotid artery revascularization, known as TCAR, with an implant-first, procedure agnostic strategy. Our approach has resonated strongly with physicians who are eager for innovation to improve outcomes and practice performance while addressing the full scope of carotid intervention. In 2023, a CMS shift further catalyzed this opportunity, positioning stenting as the emerging go-to treatment. We've built a strong foundation to capitalize on this shift with a world-class team, solid infrastructure, and a sizable balance sheet, all fueling our momentum. Thanks to our investors' confidence in our strategy and plan, we were funded and well-prepared to commercialize at approval. We're now building traction and velocity to create and capture market demand. At the core of our business, we have a stent platform delivering next-level outcomes, ready to transform the vascular market. With the assets we've built, the evidence we've generated, and the team we've assembled, we are now well positioned to execute our U.S. launch with excellence to drive growth, expansion, and shareholder value. Turning to our launch progress, in recent weeks, we've begun to strategically execute our commercial playbook and many U.S. centers. Our sales team is taking a methodical approach, leveraging claims and market data to target accounts. Early interest has been strong as we navigate value analysis committee approvals and educate providers about our differentiated stent system. As of today, we've successfully completed approvals, orders, and commercial procedures in numerous accounts and hospital systems, a reflection of the enthusiasm and demand. We are not simply executing a product launch. We are laying the foundation to redefine the carotid intervention market. A successful launch starts with the right team, and we are proud of the exceptional group we've assembled. Our sales and clinical support specialists bring deep experience in the vascular markets, establish relationships with physicians and administrators, and a proven ability to launch innovative products successfully. Their expertise and understanding of account dynamics are already driving engagement and establishing our presence nationwide. We continue to receive overwhelming interest from highly experienced professionals eager to join our team. This is a testament to the demand and awareness of Seaguard Prime in the field, the promise of the talent we've already attracted, and the sizable opportunity in a stent-first carotid intervention. Our team experienced the enthusiasm of our technology firsthand just a few weeks ago at the Society of Neurointerventional Surgery's annual meeting. The energy surrounding Seaguard Prime was unmistakable. Our booth was a constant hub of activity, drawing the attention of many prominent U.S. physicians eager to learn more about how our innovation can transform carotid care. Time and again, we're hearing from doctors who are genuinely excited to offer this technology to elevate the standard of care and improve the lives of their patients. Moments like this reinforce our conviction in our technology and in our mission. We have built the infrastructure, assembled the team, and developed the operational readiness to execute this launch with excellence. And we look forward to updating you all on our progress as we move through foundation building toward more robust commercial scale over the coming quarters. Turning now to our clinical pipeline, a critical component of our long-term growth strategy. We continue to make steady progress on multiple fronts as we work to expand the reach of our technology, build clinical evidence, and unlock the additional market opportunities. First, I'll update you on our pivotal studies in TCAR. In C-Guardians 2, we're evaluating C-Guard Prime in a catheter designed for TCAR procedures used with neuroprotection systems that are already used commercially today. This study is designed to demonstrate the safety and effectiveness of C-Guard Prime and TCAR procedures and to open this important segment of the market to our platform. We received FDA IDE approval to initiate the study in late 2024, and I'm pleased to report that enrollment continues at a good pace as we continue to work toward first half of 26 approval. At the same time, we're advancing the next phase of our TCAR strategy with C-Guardians 3, which evaluates our fully integrated TCAR solution, combining a 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. Given the variability of timelines surrounding clinical enrollment and FDA review, we now anticipate clearance and launch in 2027. Together, these two pivotal studies are designed to strengthen our competitive position in TCAR, a U.S. market that already exceeds 30,000 procedures annually, and to demonstrate the versatility and clinical value of our differentiated platform. We're also making progress in expanding the potential use of our technology into acute stroke care, particularly our tandem lesion early feasibility study, which we're conducting in partnership with Dr. Adnan Siddiqui at 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. These are highly complex, high-risk cases where embolic protection is critical, and we believe our proprietary Micronet mesh technology is uniquely suited to deliver superior outcomes in this setting. To date, enrollment is roughly halfway complete. Initial physician interest underscores the unmet need and potential impact of our technology in this challenging patient population. Each of these clinical initiatives reflect our commitment to advancing the standard of care in carotid and neurovascular disease, building evidence to support our differentiated portfolio, and unlocking new pathways for growth. We believe our dual focus on CAF and TCAR positions us to serve the broadest base of physicians while leading the shift toward a stent-first standard of care. Before I turn the line to Mike to review our Q2 performance, I want to highlight two major recent achievements that strengthen our balance sheet. Last week, we successfully entered into a securities purchase agreement with a group of leading institutional investors, raising $40.1 million in gross proceeds through a private placement. In addition, we raised $17.9 million from the exercise of warrants that were triggered by FDA approval of Seaguard Prime. This is the second tranche of warrants that were originally issued as a part of the company's milestone-based financing announced in May of 2023. These transactions achieved several important objectives in support of our growth strategy as we launched Seaguard Prime in the U.S. market. First, they deepen the commitment of several of our largest existing shareholders while expanding our investor base with the addition of high-quality investors. Second, they significantly strengthen our cash position, collectively bolstering our resources by over $58 million in proceeds, allowing us to invest in the commercial scale necessary to achieve key growth milestones and execute toward long-term profitability. Now we are even more confident in our ability to scale U.S. commercial operations effectively and position InspireMD 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?