InspireMD Inc.

Greetings and welcome to the InspireMD first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Padala. Thank you, sir. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD first quarter financial results and corporate update conference call. Joining us today from InspireMD are CEO Marvin Slossman and CFO Craig Shore. 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 updates in our corporate 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, Tuesday, May 14, 2024. 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 CEO Marvin Slossman. Go ahead, Marvin, please.

Thank you, Chuck, and thanks to everyone for joining our call this morning. I'm pleased to report that during the first quarter of 2024, we were able to sustain momentum with which we exited 2023 as we advanced toward our mission to be a leader in the carotid revascularization market with our best-in-class Seaguard Carotid Stent platform. Craig will cover the financial shortly, but I wanted to touch on a few highlights from our first quarter performance. We generated total Seaguard revenue of $1.5 million, representing growth of nearly 22% over $1.2 million that we reported in the first quarter of 2023. With our formal recertification under MDR now granted, we've de-risked this topic and removed uncertainty in our ability to continue to sell in EU-certified countries while also enabling our product development pipeline provided under MDR as we continue to build our OUS markets in parallel with our growing U.S. focus. We sold 2,553 Seaguard stents during the first quarter of 2024, representing growth of 25.6% over the 2,033 stents sold during the first quarter of 2023. Our real-world experience with Seaguard now exceeds 50,000 stents sold to date. Turning now to our ongoing C-Guardian's pivotal U.S. trial, which is evaluating the safety and efficacy of the C-Guard carotid stent system for the treatment of carotid arterial stenosis. As a reminder, the primary endpoint of this trial is a composite of the incidence of major adverse events, including death, all-cause mortality, any stroke, or myocardial infarction, abbreviated SDSM. or ipsilateral stroke from day 31 to day 365 post-procedure. Between July 2021 and June 2023, 316 patients were prospectively enrolled in the single-arm study performed at 24 sites in the U.S. and Europe, utilizing the C-Guard carotid stent system, including our next-generation C-Guard Prime platform. We announced recently an abstract of the one-year outcomes from C-Guardians has been accepted for presentation at the Leipzig Interventional Course 2024, also known as LINC, which will be presented by Dr. Chris Metzger, System Vascular Chief at OhioHealth and Lead Investigator of the study. This presentation is scheduled on May 28th in Leipzig, Germany. Recall that the 30-day follow-up from the trial was presented in the fall of 2023 at VIVA, which demonstrated all-cause mortality, death, stroke, and myocardial infarction rate of just 0.95% in the intent-to-treat analysis population and 0.63% in the per-protocol analysis population. We believe results like these have the potential to position Seaguard with our innovative Micronet mesh to be the gold standard in carotid implants. Assuming the 12-month results are positive, we would be on track to submit a premarket approval application or PMA later this year while continuing to prepare for a U.S. commercial launch in the first half of 2025 if approved. This timeline is unchanged from our prior guidance. It's also worth noting that 12-month outcomes data from Sea Guardians would trigger the first tranche of the transformational financing of up to $113.6 million we announced last May. Recall that per the terms of the private placement, which was led by Marshall Weiss with participation from Orvimed, Rosalind, Nanahala, Solius, Velen, and certain InspireMD board members, we received $42.2 million up front with four tranches of $17.9 million, each tied to the exercise of warrants upon achievement of pre-specified milestones, the first of which is the public release of primary and secondary endpoints related to one-year follow-up study results from the Sea Guardians Pivotal Trial. As a brief reminder, the remaining three milestones that would potentially trigger subsequent funding tranches are the announcement of receipt of the premarket approval, PMA, from the FDA for the Sea Guardians Prime Carotid Stent System, which we've targeted for the first half of next year. receipt of FDA clearance for the SwitchGuard T-CAR kit to include our SeaGuard Prime stent, and the completion of four quarters of commercial sales of SeaGuard in the United States, which we anticipate in the back half of 2026. Our plan to study and submit our SwitchGuard neuroprotection system, accessory kit, and C-Guard T-CAR compatible stent platform remains on track, and if cleared, will enable our offering of a complete T-CAR tool set with next-generation enhancements, including the best-performing C-Guard Prime implant. As a reminder, the SwitchGuard MPS is designed to prevent embolic debris generated during a carotid stenting procedure from traveling to the brain, passing the blood through an integrated filter, and returning it to the patient in a closed circuit to minimize blood loss during the procedure. As we've said before, our ongoing investments in both CAS and TCAR methods and tools addressing the broadest patient population was done anticipating a time when technology innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care. Last year marked the beginning of what we believe is a shift away from surgery toward less invasive stenting procedures, highlighted by CMS's final national coverage decision last October, which expanded coverage of CAS and TCAR to include both asymptomatic and standard risk patients. With a best-in-class implant and C-Guard EPS, we believe we're very well positioned to be a leader in addressing this industry sea change. We were pleased to announce this past February that Dr. Patrick Garrity, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Muck, Program Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, will be serving as our lead PIs. Together, Dr. Garrity and Dr. Muck bring a wealth of knowledge and experience in the field of TCAR carotid interventions, and we're very fortunate to be able to benefit from their extensive knowledge, insight, and direction as we build our leadership objectives and strategy. They join an established multidisciplinary group of thought leaders that are already providing guidance to us in these initiatives. We've also previously announced that we entered into a strategic agreement with the Jacobs Institute of the State University of New York and Buffalo with Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis or occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem lesions. C-Guard Prime with its proprietary Micronet mesh is designed to provide superior embolic prevention during carotid stenting procedures. We believe that this study will demonstrate safety and feasibility of using our stent in these acute stroke procedures. Our investment in the study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. The FDA has approved this study At this point, I'll turn the call over to Craig to review the financials. Craig?