InspireMD Inc.

Ladies and gentlemen, thank you for standing by. Good morning and welcome to the InspireMD first quarter 2021 financial results and corporate update conference call. This time, all participants are in listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation 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 of this call are advised that the audio of this conference call is being broadcast live over the Internet and also is being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through November 10, 2021. Now I'd like to turn the call over to Mr. Jules Abraham of CoreIR, the company's investor relations firm. Please go ahead, sir.

Thank you, Nick. And good morning, everyone. Thank you for joining us for the InspireMD second quarter 2021 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer of InspireMD, 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 in the Form 8-K filed with the FCC today and InspireMD's press release that accompanies this call, particularly the cautionary statements in it. The content of this call contains time-sensitive information that is accurate only as of today, August 10th, 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's now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer.

Marvin. Thank you, Jules. Good morning and thank you all for joining the second quarter 2021 call and webcast. Also joining me today is Craig Shore, our Chief Financial Officer. At InspireMD, our mission remains clear 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 to broad physician base as well as advance new delivery systems and accessory solutions, We believe we can enable the conversion of this surgically dominated $1 billion global market with a less invasive endovascular standard of care. The second quarter of 2021 proved highly productive for InspireMD, gaining traction in our execution milestones of global expansion, commercial growth, and development of new pipeline offerings. Revenue performance for the second quarter showed consistent improvement as elective procedures normalized and our commercial momentum grew. We achieved revenue of $1,037,000 for the quarter, a 231% growth year over year. During the quarter, we sold 1,660 devices, an increase of 210% as compared to the second quarter of 2020, with renewal of scheduled procedures and a return to pre-pandemic levels. Of our top stated priorities for 2021, most notably we began steps in the path toward commercial registration of C-Guard in the United States, with the initiation of our Sea Guardians Pivotal Trial. We've completed 12 cases of the targeted 315 total enrollment in the first three weeks, led by our Global Principal Investigator, Dr. Chris Metzger at Ballard Health System in Eastern Tennessee. As we launched the trial in the United States at 15 planned sites and with the top carotid stent leaders, We look to establish a foundation of awareness and credibility through the utilization of C-Guard, which will position us for a successful and accelerated post-approval commercial launch. In terms of global expansion, we continue our progress in China, working with our distributor partners on the regulatory trial execution plans, along with progress and expansion into new markets in Asia, such as Japan, Taiwan, and Korea. We believe these markets offer an accelerated opportunity for C-Guard, as the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated. In France, we've received clinical approval for C-Guard from the French National Authority of Health and are anticipating reimbursement approval in the coming weeks to enable our plans to launch our next direct sales market along with the UK. We're evaluating other direct sales possibilities to drive higher average sales price and more control of current and developing offerings. To enhance our growing commercialization efforts globally, we appointed a new member of our board of directors and formed a medical advisory committee with key opinion leaders to guide our progress. Seasoned MedTech marketing executive Katie Arnold, with more than two decades of strategy and commercialization in the medical device industry, joined our board of directors. Katie's knowledge and leadership will be invaluable in helping our company shape our strategic plan and expand commercially and business developments. We also appointed acclaimed interventional cardiologist Dr. Kennedy Rosenfield as the chair of the new medical advisory board. The board will provide guidance and direction on clinical need, technology advancements, and planning the company's growth and strategic direction. We continue to invest heavily in our pipeline of innovation and advancing platforms that enable more CAS procedures. We have in development two new delivery systems advancing to a possible approval in 2022 which we believe will facilitate greater accelerated access to the overall global market potential and specifically address the conversion of surgical procedures to endovascular stenting. To summarize, we're pleased with our progress focusing on establishing C-Guard carotid stent system as the foundational enabler of the stent market conversion. Our commercial focus and execution in our current 33 served markets, along with building market experience and awareness of C-Guard in the United States and Asia through the regulatory trial process, are building foundations for future success. As we chart a new course in how carotid artery disease is managed and stroke is prevented with our clinically proven C-Guard EPS system demonstrating superior clinical outcomes for patients, Thank you, Marvin, and to everyone for joining today.