Financial Data and Key Metrics Changes - Total revenue for Q2 2025 increased by 2% to $1.8 million, driven by increased usage in international markets and positive foreign exchange impacts, partially offset by decreased revenue from Russia and European distributors [23][24] - Gross profit decreased by $18,000 or 5.7% to $313,000, with gross margin decreasing to 17.6% from 19% in the same period of 2024 [25] - Total operating expenses increased by $4.7 million or 55% to $13.3 million, primarily due to headcount-related expenses and occupancy costs associated with establishing a U.S. headquarters [26] - Net loss totaled $13.2 million or $0.26 per share, compared to a net loss of $7.9 million or $0.22 per share in Q2 2024 [27] Business Line Data and Key Metrics Changes - The company did not recognize U.S. commercial revenue in Q2 2025 due to FDA approval occurring in the last week of the quarter, but has begun recognizing U.S. sales in Q3 [24] - Over 60,000 implants have been sold globally, reinforcing the company's expertise and commercial infrastructure [24] Market Data and Key Metrics Changes - The carotid intervention market is seeing a shift, with stenting becoming the emerging go-to treatment, supported by a CMS shift in 2023 [9] - Approximately 60,000 annual procedures are performed by 4,000 physicians in the U.S., with a trend towards an endovascular-first mindset [42][46] Company Strategy and Development Direction - The company aims to lead the U.S. carotid interventional market with the CGuard Prime Carotid Stent System, focusing on transforming the carotid intervention market and improving patient outcomes [7][9] - The company is executing a methodical launch strategy, building a strong commercial team and infrastructure to support growth [10][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to scale U.S. commercial operations effectively and deliver meaningful growth and value over the coming quarters [21] - The company acknowledges that strong adoption will take time and emphasizes the importance of laying a solid foundation for future expansion [28] Other Important Information - The company raised $40.1 million through a securities purchase agreement and $17.9 million from warrant exercises, significantly strengthening its cash position [20][21] - The company is advancing its clinical pipeline, including pivotal studies in TCAR and exploring new market opportunities in acute stroke care [14][19] Q&A Session Summary Question: Progress with U.S. account openings since FDA approval - Management reported strong early reception with procedures conducted with double-digit physicians and initial stocking orders secured [33][36] Question: Change in expected timelines for TCAR device clearance - Management clarified that the timeline adjustment reflects a broader window for clearance to accommodate uncertainties in product development and regulatory processes [39] Question: Account metrics and targeting strategy - The company is targeting high-volume physicians and accounts, tracking metrics such as revenue and physician engagement in the sales funnel [42][44] Question: Trends in the carotid intervention market - Management noted a shift towards stenting, with expectations of reaching a 50/50 split between surgical and stent-based procedures in the near future [46]

Core Viewpoint - InspireMD, Inc. has received FDA premarket application approval for its CGuard Prime Carotid Stent System, marking a significant milestone in the treatment of carotid artery disease [1][3]. Group 1: FDA Approval and Clinical Evidence - The FDA approval is supported by data from the C-GUARDIANS pivotal trial, which included 316 patients across 24 sites in the U.S. and Europe, demonstrating the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates in carotid intervention studies [2][5]. - The C-GUARDIANS trial showed strong evidence of the neuro-protective benefits of the MicroNet™ mesh technology used in the CGuard Prime system, with the lowest event rates for stroke, death, and myocardial infarction reported in any carotid revascularization trial [3][6]. Group 2: Product Features and Market Impact - The CGuard Prime Carotid Stent System features a novel mesh-covered design aimed at improving patient safety through sustained embolic protection, combining a large open-cell frame with a small mesh pore size to prevent plaque protrusion [4]. - With over 65,000 implants sold and studies involving over 2,000 patients, the CGuard Prime is positioned as a proven technology for treating obstructive carotid artery disease, with plans for an immediate U.S. launch following FDA approval [3][4]. Group 3: Financial Implications - The FDA approval triggers the second of four milestone-driven warrant tranches from a private placement financing of up to $113.6 million, with gross proceeds expected to be $17.9 million if fully exercised [3]. - Proceeds from the warrant tranche will support the commercial launch of the CGuard Prime system in the U.S., regulatory pathways for advanced applications, and the development of new products [3].