InspireMD Inc.

Good day and welcome to InspireMD first quarter 2023 earnings call. All participants will be 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, there will be an opportunity to ask questions. Please note that this event is being recorded. I would like to turn the call over to Mr. Glenn Carmon with Life Science Advisors. Please go ahead, sir.

Thank you, operator, and good morning, everyone. Thank you for joining us for the InspireMD first quarter 2023 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, which are 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 with 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, May 16th, 2023. 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.

Thank you, Glenn, and thanks to everyone for joining the call this morning. Without a doubt, the most significant development since our last quarterly update and one of the most significant milestones in InspireMD's history is our completion of a transformational financing through a private placement of up to $113 million. The financing was led by Marshall Weiss, with participations by Orbimed, Tolias, Nanahala, Rosalind, and Velen Capital. These are amongst the most highly regarded medical technology institutional investors, It's also worth noting that a certain number of our board members have also elected to participate in the offering. We are both inspired and humbled by this vote of confidence, which fuels our company's growth and enables our strategic goal to change the therapeutic standard of care in the carotid disease market. Pursuant to the engagement, we received an initial $42.2 million in gross upfront capital, with an additional four tranches of $17.9 million each, tied to milestones totaling $113.6 million fully exercised. The warrants are tied to the following milestones. First, the readout of top-line 12-month data from our ongoing FDA Sea Guardians IDE clinical trial. Second, receipt of premarket approval, PMA, from the FDA for the SeaGuard Prime Carotid Stent System. Third, the announcement of receipt of FDA approval for the SwitchGuard Transcarotid System and SeaGuard Prime ADCM. And fourth, the first five quarters of commercial sales in the U.S. market. The funds are intended to further catalyze our milestone execution, including approval and launching our new products in the U.S. and in our current served countries, including the CE-MARC territories, advancing our tandem lesion indication for C-MARC, and establishing a U.S.-based business operations and commercial architecture. With our balance sheet significantly strengthened, we can accelerate our plan to drive value inflection by way of advancing C-Guard EPS through the U.S. regulatory pathway while commencing the build out of a world-class commercial infrastructure deeply committed to making C-Guard broadly available to the many patients with carotid artery disease who stand to benefit from this novel advancement in fencing technology. The mission of our business remains unchanged, which is to focus on implant performance and positive patient outcomes. As a reminder of the superiority of our unmatched data from nine rigorously designed peer-reviewed clinical studies that have enrolled approximately 1,850 patients, C-Guard EPS demonstrated superior short- and long-term clinical outcomes measured by the lowest complication rates of death, stroke, and myocardial infarction as compared to both competing first-generation stent systems as well as surgical endarterectomy. Turning now to the quarter. We generated total revenue of $1.2 million, representing growth of 4.7% over the first quarter of 2022. This was driven by a 6.7% increase in sales of Seaguard EPS in our 30 served markets. As we shared in our last quarterly reporting, our temporary restriction of sales due to the loss of MDD certification in November 2022 created a gap in sales and shipments, which was resolved in the second half of the first quarter. It is significant to note that we were able to generate year-over-year revenue growth despite this restriction, but more importantly, we're able to successfully maintain sufficient inventory in our channels to avoid loss of procedural volume and access for patients to our C-Guard stent for best patient care. It is a testament to the tireless work and focus of the entire InspireMD team that we were able to maintain availability in our markets and address patient needs despite this temporary interruption of shipments. Recall that in November 12th of last year, our CE-MARC certification temporarily lapsed as European regulators transitioned from the existing MDD directive regulatory framework, which governs the marketing approval and sale of medical devices in the EU, to the Medical Device Regulation Framework, or MDR. This transition resulted in well-documented and significant delays by the European regulatory bodies in processing of application and audits under the new MDR certification. The MDR deadline for transition to updated certification has taken more than three years with multiple revisions, delays, and requirement changes, putting the entire medical device industry serving the EU markets at risk. This complexity, combined with constantly changing requirements and deadlines, has made this a challenging undertaking for all medical device companies that fall under the MDD purview. In anticipation, we proactively worked with our distributor partners to provide as much available inventory as possible to avoid shortages while continuing to complete the MDR process to re-establish sales, which we have successfully done and are now able to resume normal cadence in our sales effort. As a reminder, we enjoy greater than 25% market share in over half of our served CE marked territories, with some exceeding 80%. We believe our continued efforts on the ground, together with the launch of two new stent delivery platforms, will enable share growth and accelerate the conversion of surgeries to endovascular standard of care with the C-Guard Stent System. Our mission remains unchanged to convert the last surgery first segment of vascular medicine to an endovascular first-line standard with the best-in-class implant, the C-Guard EPS. With a full range of delivery options serving the broadest multidisciplinary physician base, we believe we are uniquely positioned to accelerate this conversion. And turning now to our U.S. regulatory activities, our C-Guardian U.S. IDE trial continues. at a robust pace for enrollment, with 20 active trial sites recruiting and treating patients. We recently announced that on May 1st, the first patient was successfully treated in our Seaguard PANS trial utilizing Seaguard Prime, the company's next generation cat stent platform. This marks a very significant milestone for the company, with Seaguard Prime used in a clinical setting, marking a significant step forward in advancing more stenting procedures. Since that first case, we've continued to rapidly enroll in the final patient set with C-Guard Prime, anticipating completion of enrollment by the end of this quarter. As a reminder, the new C-Guard Prime offers numerous benefits and advantages to physicians performing carotid revascularization, including an innovative handle design and catheter and tip construction, which makes stent trackability and deployment much easier. This gives physicians and staff a much higher degree of confidence, which we believe will contribute to its confidence and stent utilization once approved and launched. After completing enrollment in Sea Guardians, we will advance our PMA submission and approval process to get us closer to the potential launch of Sea Guard Prime in the U.S. market. In parallel, we've commenced critical commercial readiness activities in the U.S., including the hiring of Shane Gleason, a seasoned commercial executive, in the vascular space to lead our go-to-market preparation as the GM of the Americas. In terms of product pipeline, the Seaguard EPS Stent Platform remains the core of our business as we focus on the value of the implant as the single most important variable in patient outcomes. To fully realize the full potential of Seaguard, however, we've developed two new delivery platforms to drive utilization across the broadest vascular specialist community. As noted earlier, we continue to advance development, regulatory approval, and launch plans for our CAST platform, T-Guard Prime, which will be available in both standard and short-shaft versions, compatibility with development of SwitchGuard, our T-Card neuroprotection platform. In combination, we believe our transcarotid kit will enhance T-Card utilization with the best implant. We believe the breadth of our total tool set with a stent-centric focus will be a key differentiator for us as we work to unlock the tremendous potential of this rapidly evolving market segment. The winds of change and focus on endovascular first and carotid revascularization reinforce that our investment in this space will yield tremendous value as we work to lead this market transition. In summary, we're incredibly proud of this financing, which serves as a proxy of our direction and it's a transformational time for our company as we look for a bright future. With that, I'll turn the call over to Craig for a view of the first quarter's financials. Craig.