InspireMD Inc.

Good morning and welcome to InspireMD's first quarter 2026 earnings conference call. Currently, all participants are in listen-only mode. We will facilitate a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. Joining us today from InspireMD are Marvin Stockman, Chief Executive Officer Mike Lawless, Chief Financial Officer, and Shane Gleason, Chief Commercial Officer. During this call, management will make forward-looking statements which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may call actual results to differ materially from those expressed in such forward-looking statements. More information about these risks Please refer to the risk factors described in Inspire MD's most recently filed periodic report on Form 10-K and Form 10-Q or any updates in its current report on Form 8-K. Filed with the U.S. Securities and Exchange Commission and Inspire MD's press release that accompanies these calls, particularly the cautionary statements made in it. During the call today, the company may discuss certain non-GAAP financial measures. For more detailed discussion of these non-GAAP financial measures and historical reconciliations to the most comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, May 4th, 2026. Acceptance as required by law, inspired indeed, 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 Schlossman, Chief Executive Officer.

Marvin, please go ahead. Thank you, operator, and good morning, everyone.

Starting with our Q1 results, our first quarter revenue of $3.4 million was a strong start to 2026, representing growth of over 120%. This performance reflects what we continue to see globally, robust and growing demand for the C-Guard implant, driven by its highly differentiated clinical profile and strong physician demand. Before I go any further, I want to directly address the decision to pause commercialization for the C-Guard Prime 135 delivery system, which we announced last week in coordination with the FDA. While we recognize this action represents a clear setback from our commercial momentum in the United States, let me be very clear on three important points. First, this action is not related to the safety or performance of the C-Guard stent implant, which continues to demonstrate best-in-class clinical outcomes. Second, this was a proactive decision based on feedback from our controlled U.S. launch, where we identified opportunities to further enhance the technical performance, and physician experience of the delivery system. Third, we are confident. This is a temporary and correctable issue, and we have a clear path forward to restoring and expanding our U.S. commercial opportunity. Importantly, this reflects our longstanding philosophy. We prioritize clinical excellence and physician competence over speed of commercialization. We believe taking this step now ultimately strengthens our long-term market position. In parallel, we're advancing an important and near-term solution, pursuing FDA approval of our original C-Guard delivery system that has already been successfully used in more than 70,000 cases globally, as well as in the majority of the cases in the successful C-Guardians clinical trial. Our ongoing discussions with FDA are positive and constructive, and we anticipate FDA approval in the third quarter of 2026, which would enable us to reenter the U.S. market with a proven and highly reliable platform. Despite this temporary pause in the United States, the fundamentals of our business remain strong. Strong physician excitement and belief in C-Guard, continued strong international growth our TCAR strategy remains fully on track and unaffected by this voluntary action. We continue to anticipate FDA approval of the C-Guard Prime 80 system for TCAR procedures in the second half of this year, which we believe could potentially double our U.S. addressable market. Furthermore, we're pleased to have received FDA approval to initiate the C-Guardians III clinical trial, which will evaluate the company's next-generation switchguard neuroprotection system with the Seaguard Prime 80 for use in TCAR procedures. When approved, this will allow us to offer the full TCAR toolkit. Given the temporary pause in the U.S. commercialization, we have made the decision to withdraw our full-year 2026 revenue guidance. We believe this is the most responsible approach while we complete enhancements to the Seaguard Prime delivery system and gain more clarity on the specific timing of the approval for our original Seaguard platform to our return to the U.S. market. That said, we remain confident in the long-term growth trajectory of the business. During this period, the entire team remains focused on approval of the original Seaguard 135, which is already being reviewed by FDA, approval of the Seaguard Prime 80 with a TCAR indication for use with the only currently available neuroprotection system in the market, completion of design changes and approval of our improved C-Guard Prime 135 platform, enrollment of the C-Guardians 3 study for clearance of our next-generation switchguard neuroprotection system for TCAR procedures. Before closing, let me reiterate the following. We know there is a clear and growing global demand for our C-Guard implant, as proven in over 70,000 patients to date with unmatched clinical outcomes. We have taken a proactive step to enhance our delivery system in the U.S. We have a clear path to reenter the U.S. market with a commercially proven product and line extension. We believe we have a stint that can and is redefining carotid intervention, and we remain highly confident in our long-term growth plan. Mike will now talk you through the Q1 results and financial implications of our voluntary field action. Mike?