InspireMD Inc.

Greetings. Welcome to INSPIRE MD fourth quarter and full year 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press store zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Chuck Padala with Lakeside Advisors. Please proceed.

Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD fourth quarter and full year 2023 financial results and corporate update conference call. Joining us today from InspireMD are CEO Marvis Lossman and CFO Greg 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 on our current reports on Form 8K filed with the U.S. Securities and Exchange Commission and its IRMD'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 6, 2024, Except as required by law, Inspire indeed 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 this call over to Marvin Slossman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Chuck, and thanks to everyone for joining the call this morning. I'm pleased to share a tremendously productive fourth quarter, completing a remarkable end to 2023 for our company. We have carried this energy and enthusiasm into the new year as we continue our mission to lead the carotid revascularization market with our best-in-class C-Guard carotid stent platform. Looking forward to reporting one-year primary endpoint results from the C-Guardians trial in the first half of this year, with a view to potential approval and commercialization in the United States in the first half of 2025, as well as our continued focus on growth in our 30-plus served OUS markets. Our investment in both CAS and TCAR methods and tools addressing the broadest market potential was purposeful and done anticipating a time when technology innovation and procedural reimbursement moved the tides toward an endovascular standard of care. 2023 marked the beginning of what we believe to be a sea change toward this shift away from surgery with best-in-class outcomes with SeaGuard catalyzing our leadership potential. We plan to continue to build our growing body of data and real-world evidence from our OUS markets as we create inertia to lead the U.S. market post-approval. Craig will cover the financials shortly, but I wanted to share a brief review of our fourth quarter performance. We generated record total Seaguard revenue of $1.76 million, representing growth of 71.6% as compared to the fourth quarter of 2022. Recall that our fourth quarter 2022 sales were negatively impacted by the temporary expiration of our CE mark in November of last year as European regulators transitioned from the Medical Device Directive, or MDD, to the new Medical Device Regulation, or MDR, framework. We indicated at that time that the temporary suspension of our CE mark impacted our fourth quarter 2022 sales by approximately $250,000. Even considering these circumstances, on an adjusted basis, we generated year-over-year sales growth of 38%, reflecting our commercial focus on building a growing awareness of C-Guard's superior patient outcomes as we work to make it the gold standard of carotid implants globally. We sold 3,107 stents, up more than 74% year-over-year, advancing our global sales to date to more than 48,000 stents annually. building on our real-world market penetration and experience. Another significant highlight was the notification from the European regulators of our CE Mark re-certification under MDR. The transition from MDD to MDR was challenging and required us, like the rest of the medical device industry broadly, to be patient, persistent, and comprehensive in our approach to addressing these changes in requirements, timelines, and priorities during this lengthy process. 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 enabling our product development pipeline provided under MDR as we continue to invest in our OUS markets in parallel with our increased U.S. focus. Turning to C-Guardians, our U.S. pivotal IDE trial, which is designed to support approval of C-Guard Prime in the U.S. Dr. Chris Metzger, System Vascular Chief at Ohio Health in Columbus, Ohio, and Principal Investigator of the C-Guardians trial, presented 30-day follow-up data from the trial at VIVA 23 and then at V Symposium, both of which took place in November of last year. As an important reminder of the results, the primary endpoint of the trial is a composite of incidents of major adverse events, including death, all-cause mortality, any stroke or myocardial infarction, DSMI, through 30 days post-index procedure, or it's a lateral stroke from day 31 to day 365 post-procedure. Between July 2021 and June 2023, 316 patients were prospectively enrolled in a single-arm study performed at 24 sites in the U.S. and Europe, including the C-Guard carotid stent system, which also included our next-generation C-Guard Prime. With the acknowledgement of FDA, 30-day results were presented reporting best-in-class data with the lowest 30-day MACE rate of any carotid pivotal trial to date. Patients with carotid artery stenosis at high risk for carotid endarterectomy treated with C-Guard had a DSMI rate of 0.95% from procedure through 30-day follow-up. This data continues to validate the unique neuroprotective qualities of C-Guard utilizing our innovative Micronet mesh, and it's consistent in our real-world experience. We remain on track to report 12-month primary endpoint results anticipated in mid-year, followed by the submission of our premarket approval application, or PMA, in the third quarter of this year. Based on these timelines, we anticipate possible FDA approval of C-Guard in the United States in the first half of 2025. These timelines remain consistent with our prior guidance. Turning now to our major product development and clinical programs. Seaguardians 2, the clinical study of our SwitchGuard neuroprotection system, along with our short-shaft Seaguard and accessory devices for TCAR procedures, continues with intention as we look to advance our TCAR tool set with next-generation enhancements. As a reminder, the SwitchGuard NPS is designed to prevent embolic debris generated during the 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. We were pleased to announce just a few weeks ago that Dr. Patrick Garrity, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Muck, Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, have enthusiastically agreed to act as our lead PIs for C-Guardians 2, and that Dr. William Gray, System Chief of Cardiopulmonary at Mainline Health in Wynwood, PA, and Professor of Medicine at Thomas Jefferson University in Philadelphia, will act as an advisor to the company. Together, Doctors Geraghty, Muck, and Gray bring a wealth of knowledge and experience in the field of carotid interventions in both TCAR and CAS, and we are 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 multi-specialty group of thought leaders that are already providing guidance to us in these initiatives. Turning now to reimbursement, in October, the Centers for Medicare and Medicaid Services, or CMS, expanded coverage for CAFs and TCAR to include both asymptomatic patients at either high or standard risk for carotid endarterectomy. The broader availability of these less invasive options will enable physicians to tailor treatment plans to meet the needs of their individual patients. This expansion of coverage by CMS validates our strategy, which is to be agnostic to whether the stent is implanted via CAS or TCAR, as we are unique in offering comprehensive solutions. The timing of these changes and reimbursements and our potential approval of C-Guard in the U.S. provide us a tremendous opportunity to lead the market with this stent-first approach. Also during the fourth quarter, we announced a strategic agreement with the Jacobs Institute at the State University of New York in Buffalo and Dr. Adnan Siddiqui, Vice Chair 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. Seaguard Prime, with its proprietary Micronet mesh, is designed to provide superior embolic prevention during carotid artery stenting. 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 unwavering commitment to the neuro community and represents a critical component in our long-term growth strategy. We are pleased to share that FDA has approved our study, and we anticipate first patient enrollment in Q2 of this year. Before turning the call over to Craig to review the financials, I'd like to welcome Pete Ligotti, who joined in January as Executive Vice President and General Manager of North America. Pete brings more than 30 years of general management and commercial leadership experience to InspireMD, And it's the latest addition to what I believe is a truly world-class team capable of achieving our goals and growth objectives. At this point, I'd like to turn the call over to Craig for the financials. Craig?