InspireMD Inc.

Good morning and welcome to the InspireMD second quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and 0. Please note, this conference is being recorded. I would now like to turn the conference over to Chuck Padala with LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD second quarter 2022 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 this call, management will be making forward-looking statements, not historical facts, and are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. They involve risks and uncertainties that may cause actual results to differ materially from those expressed in the 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 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. The call contains time-sensitive information that is accurate only as of today, August 9, 2022, except as required by law, InspireMD disclaims any obligations 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, Chief Executive Officer. Marvin, please go ahead.

Thank you, Chuck, and thanks to everyone for joining our call this morning. During the second quarter, we continued to successfully execute on our mission to establish a new paradigm and standard of care for carotid artery disease treatment and stroke prevention. The clear highlight was revenue totaling $1.5 million, which represents a growth of nearly 48% as compared to the second quarter of last year. This increase was driven by sales of our C-Guard embolic prevention stent system. When you ignore the strengthening of the U.S. dollar versus the euro of approximately 12%, our volume of units sold actually increased by 60%. which represented 2,602 units sold this quarter versus 1,623 in Q2 of 2021 and 1,910 units sold last quarter. We believe procedural volume is a more accurate indicator of market penetration as we currently share ASP revenue with distribution partners in the majority of our markets. This will certainly convert to a more robust top line revenue as we move to a direct sales model in additional territories. This market penetration is also reflective of our market share growth, which is now greater than 20% in over half of our markets, with some territories up to 60%. These measurements of business acceleration create tremendous momentum to the runway in front of us, and we continue to innovate and drive an endovascular shift to open surgery with the best performing carotid stent in the market. The enabling features of the C-Guard platform through this novel design and proprietary Micronet mesh protection enable superior vascular patency compared with all other stent devices, including those with double-layer design, as well as open surgery. With data out to five years reflecting consistent clinical outcomes, C-Guard continues to demonstrate unmatched short- and long-term performance. Our position is further bolstered with the growing transition from open surgery to endovascular standard of care when you consider less than 35% of carotid artery disease cases are currently treated through endovascular stenting procedures. So there remains a significant percentage of carotid procedures that we believe can be converted from surgical to endovascular treatment And with a large and growing body of clinical evidence demonstrating the superiority of C-Guard relative to competing therapies and stent alternatives, we look forward to leading this conversion. Therefore, our strategy remains consistent, which is to focus on all specialists treating carotid artery disease to both convert open surgery as well as promote C-Guard as a first-line endovascular device. Turning our attention to other quarterly milestones. Our presence at an important medical conference, such as the Link Leipzig Interventional Course, held this past June, remained an important opportunity for us to demonstrate C-Guard in a live case format, as well as to meet KOLs influencing the market demand. We had a significant presence at Link this year, delivering four presentations in addition to a successful live case transmission featuring C-Guard. The live case was performed by Dr. Andres Schmidt and Dr. Andres Fisher at the University Hospital in Leipzig, Germany, performed on a 60-year-old asymptomatic male with progressive and calcified internal carotid stenosis. The procedure was successful with excellent angiographic result. Importantly, the case gave treating vascular specialists from across Europe the opportunity to see firsthand not only CGARD's ease of use, but also the benefits of its superb conformability and micro mesh protection innovation. Just a few weeks ago, we announced that Dr. Juan Perotti has agreed to be a strategic advisor to the company. Dr. Perotti is a world-renowned endovascular pioneer, having performed the first ever endovascular repair procedure in 1990 and the first carotid TCAR procedure in 1994, the latter using reverse flow for cerebral protection. Dr. Parody's vast experience, unique perspectives, and guidance will be useful as we develop new solutions to advance stroke prevention and improve long-term patient outcomes. The transition of carotid disease management from open surgery to endovascular standard of care is underway, and we believe having Dr. Parody as an advisor and supporter of our technology speaks volumes about the benefits of C-Guard relative to other stent platforms currently on the market. Turning now to other developments. In terms of our U.S. IDE trial, Sea Guardians, last quarter we indicated that we opened our first European trial site and enrollment has been accelerated. We currently have 18 U.S. sites enrolling patients with plans for four more. And in Europe, four sites are now enrolling and one more is expected to begin cases this month for a total of five. All 22 enrolling sites are building cases at an accelerating pace, which is encouraging. Our current outlook remains consistent. with enrollment completion by approximately Q1 2023. Regarding Japan, our discussions with potential distribution partners interested in representing SeaGuard are ongoing, and we're pleased to be seeing a very high level of interest. An agreement once executed would complement the distribution agreement we have in China that was signed last year. Asia is a very important market for us, and the existing standard of care for procedural intervention is predominantly endovascular focus and less surgically dominated than the U.S. and certain European markets. In February, we announced that C-Guard EPS would be included as a treatment option in the stenting arm of the CREST-2 trial, which is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent strokes for asymptomatic patients with significant carotid disease. We view this as yet another important validation of our technology to be approved as an advanced STEM platform to participate in such an important market effort. We've completed readiness for 20 sites to use C-Guard and we anticipate the first patient treatments to be completed soon. In terms of product platform, the C-Guard EPS STEM platform remains the foundation of our business as the device drives patient outcomes beyond the selected delivery option. To fully realize the full potential of C-Guard, we've invested in two new delivery systems to drive utilization across the broadest vascular specialist community. We continue to advance development of our new transfemoral delivery system, C-Guard Prime, which will be available in both standard and short-shaft versions, compatible with the development of SwitchGuard, our TCAR accessory device. In combinations, these will offer a transcarotid option to our portfolio. designed for those clinical needs and conversion of greater surgical procedures to the C-Guard EPS stent. We continue to work tirelessly toward our goal of changing the paradigm of how carotid stenosis is managed. With C-Guard EPS, we believe we can offer the best patient outcomes and the broadest set of tools to unlock the tremendous potential of this rapidly evolving market segment. With that, I'll turn the call over to Craig for a review of our second quarter financials. Craig?