InspireMD Inc.

If you need audio assistance during today's program, please press star zero. Hello and welcome to InspireMD's fourth quarter 2024 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. Please go ahead.

Thank you for joining us for the InspireMD fourth quarter 2024 conference call. Joining us today from InspireMD are Marvin Salzman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During the 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 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, March 12, 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 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 strong fourth quarter and full year performance. TGARD revenue reached a new quarterly high of $1.95 million in the fourth quarter, reflecting a 10.6% growth year over year with $7 million in revenue for the full year 2024. translating our momentum in unit sales of 3,512 C-Guard stents sold for the quarter and 12,100 units for the full year, thus benefiting thousands of patients in our end market suffering from carotid artery disease. These results contribute to more than 60,000 implants sold to date as a testament to our strong global commercial foundation and real-world experience, as we build toward anticipated approval and launch of Seaguard Prime in the United States. I'm pleased to share that we remain on track for an anticipated U.S. approval and launch of Seaguard Prime in the first half of 2025. With the potential approval, I'd like to illustrate how our global Q4 sales would translate in U.S. market revenue to help frame the potential opportunity. With 3,512 stents sold internationally during the fourth quarter, Had this number of stents sold in the U.S., they would have generated over $16 million in revenue, assuming a balanced mix between CAS and TCAR sales at current U.S. market ASPs. To put this in perspective, we estimate that more than 7,000 U.S. TCAR procedures were performed in the fourth quarter, making our global unit sales close to 50% of the U.S.-only TCAR market before we've even entered the market with both CAS and TCAR solutions. Therefore, with the U.S. market entry of both CAS and TCAR platforms, we are confident in the significant revenue expansion upon regulatory approval. To recap our regulatory status in the U.S., in September 2024, we submitted the final module of our premarket approval, our PMA application to FDA, and have since engaged in an interactive review process. We are optimistic for a timely and positive decision which would enable our U.S. market launch of SeaGuard Prime, triggering the commercialization of our best-in-class STEM platform in the U.S. While our review continues with FDA, we've been diligently building a world-class commercial and operational engine to support our highly anticipated U.S. launch. We are not just prepared, but ready to aggressively execute a robust commercial and operational launch plan. We believe Seaguard Prime is poised to redefine carotid artery disease treatment and stroke prevention and plan to fully capitalize on the shift toward an endovascular-first approach. Our new headquarters in Miami, Florida is strategically positioned to support the anticipated U.S. launch and commercialization of Seaguard Prime upon approval. This state-of-the-art facility represents our commitment to scaling operations in the U.S. and further strengthens our ability to execute on a national level. Contingent upon U.S. approval, we also believe we are well positioned to meet robust demand for Seaguard Prime as our infrastructure and operations will support significant growth and success in the U.S. market. In addition to building the support functions of marketing and commercial operations, we have onboarded more than a dozen world-class field sales professionals and will continue to build our field sales presence with intention over the next 24 months. There is overwhelming interest from highly talented seasoned professionals interested in joining our organization at this pivotal time, reflecting the potential of Seaguard Prime and the shifting change in the landscape of carotid revascularization. Given us confidence in our submission and the pending approval of Seaguard Prime is the overwhelmingly positive one-year data from the Seaguardians Pivotal Clinical Trial, first presented at the Leipzig Interventional Course in 2024. This trial evaluated the safety and efficacy of C-Guard and C-Guard Prime in treating carotid artery stenosis, enrolling 316 patients across 24 trial sites in the U.S. and Europe. The C-Guardian's results demonstrated an unprecedented primary endpoint with major adverse events rates of just 0.95% through 30 days and 1.95 percent through 12 months post-procedure, making this the lowest event rate ever reported in a pivotal study of carotid stent or embolic protection device. As a reminder, receipt of premarket approval from the FDA would also 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 for the company, like the first tranche, which was triggered this past July upon the presentation of positive one-year Sea Guardians pivotal data. After pre-market approval, the remaining two milestones would each trigger additional tranche financings, including receipt of FDA clearance for the SwitchGuard TCard neuroprotection system, along with our TCard-indicated TCard Prime stent, and the completion of four 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. Shifting gears to our clinical pipeline, as a reminder, in October we received the FDA approval for an Investigational Device Exemption, or IDE, application to begin the C-Guard Institute pivotal study of our C-Guard Prime carotid stent system and TCAR procedures. This study is intended to evaluate the safety and effectiveness of our novel C-Guard Prime Stent platform in a short TCAR-indicated version compatible with commercially available neuroprotection systems for TCAR procedures. I'm pleased to share that we are enrolling very well in this study as we progress into 2025. We've also engaged with FDA in the filing of our C-Guardians III IDE for the investigation of our complete TCAR solution, including the C-Guard Prime 80 Stent and switchguard neuroprotection system and anticipate approval to initiate the study in the second quarter of this year. With more than 30,000 TCAR procedures performed in the U.S. annually, TCAR is a large market opportunity that remains strategically important as we build a comprehensive approach to carotid revascularization. Our ongoing investments in both CAATS and TCAR are aimed at serving the broadest physician base, positioning us to lead as product innovation and procedural reimbursement continue to shift toward an endovascular first standard of care. At this point, I'd like to turn the call over to Craig to review the financials. Craig?