InspireMD Inc.

Good morning and welcome to the InspireMD third quarter of 2023 earnings call. Currently, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press start in zero on your telephone keypad. Please note that this conference is being recorded. I would now like to hand the conference over to Mr. Chuck Badala, with LifeSite Advisors. Thank you. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining us to the InspireMD third quarter 2023 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slossman, 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 uncertainty 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 on 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 symptoms of information that is accurate only as of today, November 6, 2023, 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 Slossman, CEO.

Please go ahead, Marvin. Thank you, Chuck, and thanks to everyone for joining the call this morning. The third quarter proved to be a transformational time for our company with several milestones, further validating our strategy and mission to transform the carotid revascularization market with a superior next generation stent implant, along with our focus on the broadest range of tools, providing both patients and physicians optimal procedural solutions. Execution against internal objectives remains our focus, but I would like to start today with a brief mention of the recent national coverage decision by CMS enabling a monumental shift by expanding reimbursement for carotid artery stenting or CAS procedures to include both standard surgical risk and asymptomatic patients, neither of which were previously covered. We will get into those details shortly. In terms of our financials for the third quarter of 2023, we generated total revenue of $1.556 million on 2,734 devices sold, representing nearly a 9% revenue growth over the comparable period in 2022. Measuring procedural volume continues to be a key metric of our success as our distributor model discounts our average sales price by way of transfer pricing. Unit sales more accurately measures market share and our served territories, a key driver of our growth objectives. As we drive market awareness, utilization and global expansion, implant performance will remain the cornerstone of our focus, having now established a baseline of real world experience and world class data with more than 45,000 C-Guard stents sold to date and nearly 2,200 patients enrolled in clinical studies. We were pleased a few days ago to present the 30-day data from our Sea Guardians IDE clinical trial at the VIVA conference. As a reminder, the Sea Guardians trial is designed to support a PMA submission in the second half of next year, which would give us line of sight to possible approval of Sea Guard EPS in the U.S. in the first half of 2025. Reviewing the results from July 2021 through June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting, or CAST, study performed at 24 sites in the U.S. and Europe, utilizing C-Guard EPS as the carotid stent system. The primary endpoint is a composite of incidents of major adverse events, including death, all-cause mortality, any stroke or myocardial infarction through 30 days, post-index procedure, or ipsilateral stroke from date 31 to date 365. All events are adjudicated by a clinical events committee. Dr. Chris Metzger, the PI of the Sea Guardians trial, presented unprecedented data at 30 days, total major adverse events, DSMI, of 0.95%, as measured by intent to treat analysis considered to be the most rigorous measure of results. These first-in-kind results demonstrate the neuroprotective effect of the C-GARD stent and add to the significant and growing body of evidence showing that C-GARD delivers outstanding short and long-term patient outcomes as compared to alternative stent and the current standard of care in revascularization carotid endarterectomy. We were pleased to share these compelling results at VIVA, which is among the most important gatherings of endovascular specialists and should go a long way toward raising awareness of C-GARD among the endovascular community, key opinion leaders, and other practitioners alike. Staying on the topic of our IDE trial for a moment, we announced in June that we had completed enrollment of this trial, something that was achieved in just 23 months. And recall that this study also includes the 1st, human cases performed with our new C guard prime cast and delivery system. Study follow up is progressing as planned. And we reiterated our expectation for primary endpoint results in the 2nd, half of next year with anticipated approval in the 1st, half of 2025. Revisiting one of the key market drivers transforming revascularization towards stenting, on October 11th, CMS issued a National Coverage Determination, or NCD, implementing coverage of CAS for both symptomatic and asymptomatic patients, whether considered to be high or standard risk for surgery. This coverage determination is very consistent with the draft memo that was released in July. The updated NCD creates a very meaningful expansion of the addressable market for CAS and will shift the standard of care toward a patient-first approach with greater procedural options, including stenting. This adds to our enthusiasm for the U.S. market opportunity for C-Gard Prime for both CAS and TCAR, both of which are an integral part of our long-term sales strategy. We believe that broader access to endovascular options is good for patients. Recall that C-Guard APS has demonstrated outstanding clinical results now in nearly 2,200 patients who were studied in rigorous clinical trials, published in peer-reviewed journals, and tens of thousands of real-world procedures performed to date, establishing a foundation of best-in-class results. This expansion of reimbursement and the broader trend toward an endovascular-first shift away from surgery support the approach we have advocated for some time. The consistent driver of outcomes remains the performance of the stent implant, which will remain our priority as clinical evidence remains the cornerstone of our story, leveraging our third-generation C-Gard stent with its proprietary Micronet mesh. In anticipation of potential approval for C-Gard in the first half of 2025, we've initiated pre-commercial activities in the U.S., and we continue to build out what I consider to be a world-class leadership team. Last month, we announced the hiring of Dr. Patrick Furto as our new executive VP of clinical and medical affairs. Patrick adds tremendous experience in the karate field, having supported much of its clinical advancement over the last 20 years, and he brings an impeccable reputation amongst key opinion leaders, medical and regulatory bodies. We also announced the hiring of Cheryl Tall to lead our quality assurance and regulatory affairs function with tremendous expertise in building business scale and capability on a global level. And finally, after six months of having a significant impact as our General Manager of North America and VP of Global Marketing, Shane Gleason has been promoted to Chief Commercial Officer, expanding his responsibilities to support our global commercial growth. I would like to close with a word on behalf of our team based in Israel for their remarkable tenacity and bravery to deliver on commitments and objectives, allowing our company to operate without interruption during such a profoundly difficult time. It is truly a testament to our team fulfilling our mission to deliver the best life-saving and stroke-preventing devices to patients worldwide. I'm now pleased to re-welcome Craig Shore back to the call as our CFO. Craig?