InspireMD Inc.

Greetings and welcome to InspireMD fourth quarter and full year 2021 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 star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn this 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 fourth quarter and full year 2021 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. These are based on management's current expectations, beliefs, and projections, which may, uh, 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 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. Security and Exchange Commission. and InspireMD's press release that accompanies that call, particularly the cautionary statements made in it. The call contains time-sensitive information that is accurate only as of today, March 8th, 2022. 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, Chief Executive Officer. Marvin, please go ahead. Good morning.

Let's begin with a reiteration of our mission at InspireMD to establish C-Guard EPS as the standard of care solution to change the way carotid artery disease is managed and strokes are prevented. The C-Guard carotid stent system enables this change through its unique design and proprietary Micronet mesh protection, which has yielded an unmatched and growing body of clinical evidence in real-world practice, as well as ongoing clinical studies. We serve equally all physician specialists treating carotid artery disease with focus on the stent system and patient outcomes. As we create greater awareness of the advantages of C-Guard as a first-line option for preventing brain embolization, not simply during the carotid stenting, but also after the procedure, our scientifically validated Micronet mesh feature enables this unique clinical advantage, and in combination with our next-generation delivery system, along with our new trans carotid accessory solution, we believe we can enable the conversion of this surgical dominated $5 billion global total addressable market to a less invasive endovascular standard of care. We will advance this topic later in the discussion. 2021 proved to be a year of change with more commercially focused on our increased C-Guard users and procedures in our 40 served markets to create awareness and experience within the US physician community through utilization in the C-Guardians FDA trial and our extensive studies of the device with numerous clinical trials, which continue to demonstrate solid clinical evidence of C-Guard's superior clinical results to an ever-expanding endovascular focus market, which has yielded many new users and foundationally grown C-Guard as a leader in the carotid stenting field. C-Guard's unique and proprietary design makes it the most advanced treatment for carotid artery disease. over all other stent technologies and surgical endarterectomy, a highly invasive surgical procedure. Execution of our strategic priorities, financial stability, and the growth of our commercial footprint all continue with focused determination as we enter 2022. As for 2021 results, our commercial business grew 56% year-over-year in C-Guard sales, representing shipments for procedures of approximately 7,000 units. Sales in our top eight markets grew by 67%, driven primarily by increases in market share. For example, in Italy, we achieved 36% market share of the existing cast implants, up from 26% the prior year. Procedural volume reflects an important measure of the strength and size of our business, as we currently share a portion of the average sales price in major markets with our distributor partners, further emphasizing our priority to convert more markets to a direct sales approach to fully capture top line revenue recognition. To date, we have sold over 28,000 Seaguard EPS systems, building a strong foundation of unmatched clinical data, both short and long term, as the best performing, most studied, and safest carotid stent in the market. Our advancing enrollment in SeaGuardian's FDA IDE trial continues with 12 sites currently enrolling in the U.S. with plans to start three more along with four in Europe during the second quarter. Our patient enrollment over the past 60 days has accelerated rapidly with more investigator experience and confidence in SeaGuard yielding continuous enrollments at sites following the initial launch. We have invested in a world-class team and partners to drive enrollment and study execution, and thus far we are pleased with our rapidly growing case results. Our current outlook is to complete the enrollment of the trial in Q1 2023. Principal Investigator Dr. Chris Metzger at Ballad Health System in Eastern Tennessee continues to lead the enrollment with 50 cases to date and guides our direction. As we previously discussed, in 2020, we successfully raised sufficient capital to fund our strategic plans, providing sufficient runway to complete what we believe to be significant milestones in 2022 and 2023. In Europe, we continue to build a momentum in France as our most recent country to be approved and reimbursed for Sea Guard, and we have hired direct sales representation to capture the momentum of this latest launch. Concurrently, we continue to accelerate our plans to advance our direct sales effort in other selective strategic locations to capture higher average sales price and enable greater control of the sales process to drive growth with focused attention to new tools and accessories, as we have demonstrated in the UK and France. Our strategy in Asia continues, including talks in Japan with distributor partners interested in representing SeaGuard. As we noted previously and consistent with our agreement in China, we believe the Asia market offers an opportunity for C-Guard as the existing standard of care for procedural intervention is predominantly endovascular and less surgically dominated. Our strategic commercial pathway for C-Guard continues with a new transfemoral delivery system, C-Guard Prime, offering greater navigation and flexibility to address more challenging patient anatomy as well as a broader set of evolving indications. We will offer C-Guard Prime in both standard and short-shaft versions compatible with our development of our TCAR accessory device, enabling a trans-carotid solution designed for conversion of vascular surgeons who perform the vast number of carotid revascularizations. Both devices are planned to launch in late 2022, early 2023. and we believe will foundationally change the landscape of C-Guard utilization to the broadest group of specialists performing endovascular procedures. Our mission is to serve all who treat carotid artery disease with tools to enable C-Guard stent placements for best patient outcomes. As we chart a new course for how carotid stenosis is managed and how strokes are prevented with our clinically proven C-Guard EPS system, our mission is to provide the best patient outcomes and broad set of tools to unlock the tremendous potential of this rapidly evolving market segment. With that, I'll turn the call over to Craig to review our financial results.