InspireMD Inc.

Good morning and welcome to the INSPIRE MD third quarter 2022 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'll now turn the conference over to Chuck Vidala with LifeSci Advisors. Thank you. You may begin.

Thank you, operator. And good morning, everyone. Thank you for joining us for the InspireMD Third Quarter 2022 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Flossman, 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 to 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, November 8th, 2022. Except as required by law, it's by RMDs. This claims 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 Flossman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Chuck, and thanks to everyone for joining our call this morning. Our third quarter results reflect a continuation of our recent progress and momentum. We generated total Seaguard revenue of over $1.4 million, representing growth of nearly 39% over the third quarter last year. During the quarter, we sold 2,624 Seaguard stent systems as compared to 1,709 in the same period a year ago. This represents a growth of 54% year over year. As we share a portion of our sales revenue with distributors in the majority of our markets, procedural volume is a more accurate indication of market penetration and share retention. As we indicated last quarter, we currently enjoy greater than 20% share in approximately half of our markets, with some territories up to over 80%, which remains the bellwether of our focus in dominating the carotid revascularization space with the C-Guard stent system across the broadest vascular specialists treating patients. Launching our new delivery systems, including a new trans-carotid and advanced next-generation transfemoral platform, will enable share growth and accelerate the conversion of vascular surgeons converting to our endovascular platform. As a reminder, amongst vascular interventions, carotid artery disease lags all other procedures in terms of percentage of cases that are treated endovascularly estimated at 25% currently. So when you look at the availability of conversion of procedures to stenting, there remains a significant number of surgical procedures that we believe can be converted with our next generation Micronet mesh protected device, driven by our unmatched clinical data now out as far as five years with best patient outcomes as compared to both first generation stents and open surgery. In terms of market conditions, the regulatory landscape in Europe for all medical device companies remains in the midst of a sea change with new compliance regulations under the new MDR certification for CEmark. We are working with our notified body on compliance and to secure the continuation of our certificate under the new regulation, which currently ends November 12th, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delays in the certification process. Our presence at important medical meetings is also a key component of our long-term growth strategy and provides an effective platform from which we can espouse the many benefits of C-Guard as compared to both conventional stents and surgery. In September, the C-Guard Optima study was selected in the 2022 TCT conference to be presented as a part of the featured research program. The presentation, which was delivered by Professor Piotr Misialek, reviewed the findings of this multicenter investigator-initiated trial known as C-Guard Optima, comparing both procedural residual plaque prolapse through the stent struts and clinical outcomes of patients treated with C-Guard versus objective performance goals after carotid stenting. Professor Misialek described the results as unprecedented because of the total elimination of carotid artery-related plaque prolapse with C-Guard measured with systemic IVUS ultrasound assessment. The clinical outcome showed at 30 days an ipsilateral minor stroke rate of only 0.57% and no major strokes. This presentation adds to the significant body of evidence that we have compiled over the years, including 1,850 patients demonstrating unmatched performance and stroke prevention delivered by C-Guard with its proprietary Micronet mesh protection. versus all other cast stent platforms and surgical treatment options currently available. Therefore, our strategy remains unchanged, which is to focus on stent performance through superior outcomes and patient care with all specialists treating carotid artery disease. Now turning to other developments. In September, we jointly announced with NAMSA, a leading comprehensive medical technology contract research organization, that we have entered into a strategic partnership agreement to accelerate new product development and commercialization. Speed to market is a critical success factor for any new medical technology, and given the increasingly complex regulatory and clinical requirements in many markets, NAMHSA's full continuum of development services will serve us well as we work to further expand our pipeline as quickly and efficiently as possible. In terms of our US IDE trials, see Guardians. We currently have 19 US sites enrolling patients with plans for two more in Europe. Five sites are now enrolling, and all 24 are actively enrolling sites that are building cases in an accelerating pace, which is very encouraging. Our current outlook remains consistent with enrollment completion by approximately Q1 of 2023. Regarding Japan, we have made progress since our last quarterly update in our discussions with potential distributor partners interested in representing SeaGuard and we continue to see a very high level of interest. An agreement, if executed, would complement the distribution agreement in China we signed last year. As we have noted in the past, Asia is a very important market to us as the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated than the US and certain European markets. In terms of product pipeline, the Seaguard EPS stent platform remains the foundation of our business as the device drives patient outcomes beyond the selected delivery option. To fully utilize the full potential of Seaguard, we are developing two new delivery systems to drive utilization across the broadest vascular specialist community. We continue to advance developments of our new transfemoral delivery system, Seaguard Prime, which will be available in both standard and short-shaft versions compatible with the development of SwitchGuard, our TCAR accessory device. In combination, these will offer a trans carotid option to our portfolio designed for those clinical needs and conversion of greater surgical procedures to the C-Guard EPS stent platform. 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 brought a set of tools to unlock the tremendous potential of this rapidly evolving market segment. We look forward to a catalyst-rich 2023 as we continue to establish CGARD as standard of care. With that, I'll turn the call over to Craig to review our first quarter financials. Craig.