InspireMD Inc.

First quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anybody would need operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. At this time, I'd like to turn the call over to your host, Chuck Padala, LifeSci Advisors. Thank you. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining us for the InspireMD first 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, that 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 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 this call, particularly the cautionary statements made in it. The call contains time-sensitive information that is accurate only as of today, May 10, 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. Go ahead, please, Marvin.

Q1 2022 proved to be a very busy and productive quarter at InspireMD, with approximately 1,910 C-Guard stent systems sold to our 31 served markets, representing revenue of $1.161 million. We accelerated enrollment in our C-Guardians FDA trial, including initiating our first European site, preparing for enrollment of the first randomized cases in the CRES-2 trial, received regulatory approval for our European logistics hub, enabling our direct sales in the UK and France, and prepared for expansion into more direct sales markets. We added five new members of our expanding global team, including seasoned sales and marketing professionals, as well as bolstering our world-class engineering department to keep pace with our expanding R&D programs and commercial growth. Our mission at InspireMD is to establish a new standard of care for addressing carotid artery disease and stroke prevention, which is foundationally different than any other company. Best patient outcomes, both short and long term, depend on a stent platform which delivers unmatched clinical results to this ever-expanding endovascular-focused market. The C-Guard carotid stent system, through its unique design and proprietary Micronet mesh protection, delivers and maintains superior vascular patency compared to all other stent devices and open surgery. In order to enable this change to better patient care and to make C-Guard ubiquitous in this market, we're focusing on all specialties treating carotid artery disease. By approaching this market in this comprehensive stent-centric approach, we believe we can enable the conversion of this surgically dominated $5 billion global total addressable market to a less invasive endovascular standard of care with sustained results. Revenue for Q1 was $1.161 million, reflecting a 20% growth year-over-year in C-Guard sales on 1,910 procedures and units sold. It is important to note procedural volume as a more accurate indicator of the strength and size of our business as we currently share a proportion of the average sales price in the 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. Our European hub will facilitate and accelerate our planning of a more direct market conversion for distribution during 2022. Turning to our advancing enrollment in the Sea Guardians FDA IDE trial, our expanded site training and enrollment continues with 13 sites currently enrolling in the U.S. with plans for three more, along with our first site in Europe with plans to start three more there, all during the next two quarters. Patient enrollment continues to accelerate rapidly with more investigators experience and gained confidence in C-Guard. Our current outlook remains consistent, anticipating the completion of enrollment of the trial in Q1 2023. We continue talks in Japan with distributor partners interested in representing C-Guard, which would complement our distribution agreement in China signed last year. We believe the Asian market offers an opportunity for C-Guard, as the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated. As we announced in our previous reporting, our commercial pathway to business growth for C-Guard will be facilitated by a new transfemoral delivery system, C-Guard Prime, offering a greater navigation flexibility to address challenging patient anatomy as well as broader set of evolving indications. C-Guard Prime will be available in both standard and short-shaft versions compatible with the development of our SwitchGuard TCAR accessory device, thus enabling a trans carotid option for our toolset designed for those clinical needs and conversion of greater surgical procedures to a stent platform with C-Guard EPS. Both devices are planned to launch in early 2023, and we believe will foundationally change the landscape of C-Guard utilization to the broadest group of specialists performing endovascular procedures. Thus far, the feedback from our KOL community has been enthusiastic and encouraging. As we chart a new course of 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 a set of tools to unlock this tremendous potential in this rapidly growing and evolving market segment. With that, I'll turn the call over to Craig to review our first quarter financials. Craig?