InspireMD Inc.

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the InspireMD year-end 2020 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one, on your telephone keypad. To withdraw your question, please press star then two. Participants on this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through June 9, 2021. I would now like to turn the call over to Scott Gordon, president of Core IR, the company's investor relations firm. Please go ahead, sir.

Thank you, Andrew. Good morning, everyone, and thank you for joining us for the InspireMD year-end 2020 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slosman, chief executive officer, and Craig Shore, chief financial officer. During this call, management will be making forward-looking statements, including statements that address InspireMD's expectations for future performance or operational results, particularly in light of the COVID-19 pandemic. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those 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, the Form 8-K filed with the SEC today, and InspireMD's press release that accompanies this call, particularly the cautionary statement in it. The content of this call may contain time-sensitive information that is accurate only as of today, March 9, 2021, 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 Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Scott, and thank you all for joining the call and webcast today. The year 2020 began as a year of transition and optimism. and despite of the unprecedented historical impact throughout the world and in particular the healthcare community as a result of COVID-19, we not only weathered these challenges at InspireMD but have become stronger by way of many important milestones achieved during the year. We set a focus direction in 2020 built around our C-Guard EPS platform to advance awareness, utilization and recognition within the medical community of the value and superiority of C-Guard. as measured by our growing body of clinical evidence and positive patient outcomes in stroke prevention. C-Guard's unique and proprietary design makes it the most advanced treatment of carotid artery disease of all other stent technologies and endarterectomy, a highly invasive surgical procedure. Inclusive of all vascular specialty and delivery system options, our goal is to continue to establish C-Guard as a carotid device of choice amongst physicians across the multiple clinical specialties that treat carotid artery disease. Our team's performance during these times remained steadfast as we focused on availability of our products to our served markets with a patient-first mindset. Execution of our strategic priorities, financial stability, and the growth of our commercial footprint all continued with focused determination. As expected, revenue performance for the year was impacted primarily by the effects of COVID-19, which restricted elective procedures across our markets. We anticipated procedures to return to pre-pandemic levels and even grow as vaccines continue to roll out globally, and we will return to a more normalized way of life. Even with the headwinds of extraordinary and unforeseen one-time historic events, we experienced a promising year of remarkable milestones and have positioned our business for success. Supporting and growing our customers' use of C-Guard EPS for treating carotid artery disease in our 33 served markets remains our top priority. We are proud to have sold over 21,000 C-Guard EPS systems to date, continuing to grow the number of patients receiving the best performing and safest carotid stent in the market. We continue our global expansion and market penetration goals including achieving regulatory registration and distribution for Seaguard EPS in Brazil, the largest market for medical devices in Latin America. More recently, we secured an investment and product registration agreement with a key medical device partner, enabling the commercial availability of Seaguard EPS to the Chinese market. We are also pleased to have settled a dispute with a former distributor dating back to 2014, permitting us to advance our business with a clean slate. Perhaps our biggest achievement this past year was receiving approval from the U.S. FDA for our Investigational Device Exemption, or IDE, application to initiate a pivotal clinical study of C-Guard EPS in the United States. Bringing C-Guard to the U.S. market is a top priority for InspireMD, and we are pursuing that objective methodically and with measured tenacity. To that end, we recently partnered with a world-class CRO, Heart Clinical Consultants, who will provide the clinical support to the upcoming global IDE trial with significant expertise in successfully conducting global trials in the cardiovascular market. Additionally, we are pleased to announce world-renowned interventional cardiologist Dr. Chris Metzger has agreed to lead the trial of investigators who will conduct the IDE trial now named the Sea Guardian Study. We also welcome Dr. Christina Brennan, a leading clinical researcher at Northwell Health System in New York, who will assist with the trial execution. We previously announced the addition of Dr. Gary Rubin, a pioneer in carotid artery stenting, to our board of directors, and he remains actively involved in the trial effort, guiding our strategic planning as well. In addition, we continue to build out our senior leadership team, adding Mr. Patrick Jamnick as our vice president of business development and strategic initiatives, and Mr. Andrea Tomasoli as senior vice president of global sales and marketing, both of whom will develop and implement the strategies to execute on our aggressive commercial goals. Perhaps our most impactful event for the company was our ability to have recently completed a targeted oversubscribed capital raise of $20.7 million. This should provide us with the essential financial support needed to complete our Sea Guardian study, which is the first step to the U.S. market, as well as funding company operations through 2023, including our expanding R&D efforts. with a pipeline of new delivery solutions to facilitate broader and greater utilization of C-Guard. Our strategic commercial pathway to business growth for C-Guard includes expansion of market share across the multiple clinical specialties that treat carotid artery disease by making C-Guard APS the first-line stent solution with continued focus on conversion of vascular surgeons who perform the vast number of carotid revascularizations. This is a significant sea change for growth, and we will continue to work diligently to increase awareness and foster these conversions in our current and future markets. Speaking of growth markets, we filed for registration and reimbursement in France, plan to establish a direct sales effort as a part of our enhanced overall go-to-market strategy. Japan, Taiwan, and Korea are also advancing market expansion opportunities, as well as our overall Asia growth initiative combined with our China agreement. In our served markets, we have plans to expand our online training and proctoring efforts along with reinstating our Centers of Excellence or COE programs, which prior to COVID provided highly effective educational support of new users for the C-Guard platform. Finally, we are advancing our work with new tools, accessories, and portfolio additions to support broad utilization of C-Guard and look forward to providing progress updates soon. As we look back at the past year of unprecedented challenge and the unpredictability of the market, we also look forward with optimism to a renewed consistency in patient care in 2021. We remain entrenched in our fundamental value proposition, which is to change how carotid artery disease is managed and stroke is prevented with our clinically proven proprietary platform solution, the C-Guard Embolic Protection System. Historically, physicians have had to make inherent compromises in choosing a carotid artery stent with either open or closed cell designs. C-Guard EPS eliminates those compromises, and it offers the best of both worlds by simultaneously providing open and closed cell features with performance that we believe to be the most advanced protection of embolic events as a leading cause of stroke. Seaguard's unique Micronet technology mitigates the prolapse of plaque into the lumen of the artery and thus prevents associated embolization. It continues to demonstrate superior clinical outcomes for patients compared to alternative carotid stent types, conventional or next-generation double-layered stents, as well as invasive surgical procedures such as endarterectomy. Seaguard has demonstrated clinical superiority in protected treatment of carotid artery disease with the potential to firmly establish a new standard of care. And to that end, we aspire and are committed to improving outcomes for patients and changing the practice of vascular medicine. With that, I'll turn the call over to Craig to review our year-end and fourth quarter financials. Craig?