Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $2.5 million, representing a year-over-year growth of 39% and a sequential growth of over 40% [4][14] - Gross profit increased by $450,000 or over 100% to $864,000 compared to $414,000 for Q3 2024 [15] - Gross margin improved to 34.2% of revenue during Q3 2025, up from 22.9% in Q3 2024 [16] - Net loss for Q3 2025 was $12.7 million, or $0.17 per share, compared to a net loss of $7.9 million or $0.16 per share for the same period in 2024 [17] Business Line Data and Key Metrics Changes - U.S. revenue for Q3 2025 was $497,000, marking the first quarter of recorded U.S. commercial revenue following FDA approval [14] - International revenue for Q3 2025 was $2.0 million, an increase of 12% compared to $1.8 million in Q3 2024 [14] Market Data and Key Metrics Changes - The company has completed over 100 cases in the U.S. since the launch of CGuard Prime, with many procedures performed in large Integrated Delivery Networks (IDNs) [6][28] - Globally, the company has sold nearly 70,000 stents to date, reflecting a shift in the carotid interventional market towards a stent-first approach [6] Company Strategy and Development Direction - The company aims to drive sustainable penetration and growth in the market for CGuard Prime, focusing on building traction methodically [5] - The clinical pipeline includes multiple programs and studies to expand the reach of the technology, with expected FDA approvals for new products in the coming years [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong early momentum in the U.S. and continued demand for the CGuard stent platform internationally [4][19] - The company anticipates revenue of approximately $2.5-$3.0 million in Q4 2025, with expectations for continued growth in U.S. sales and stable international demand [19] Other Important Information - The company raised gross proceeds of $40.1 million through a PIPE offering and $17.9 million from the exercise of milestone-based financing tranches [18] - The new Chief Medical Officer, Dr. Peter Sukas, will oversee clinical and medical topics to advance awareness of the technology [9] Q&A Session Summary Question: Initial physician feedback on CGuard Prime - Management reported strong enthusiasm from physicians, with a solid foundation of clinical data and real-world experience leading to positive anticipation for the U.S. launch [21] Question: Metrics on U.S. launch, including device ASP and account onboarding - The company is positioning CGuard Prime as a workhorse product with a modest premium pricing strategy, aiming for broad adoption [26][28] Question: Breakdown of revenue guidance for Q4 - The guidance consists of stable international sales with expectations for growth in the U.S. market [35] Question: Ordering patterns from initial users - Initial orders are being placed with a focus on utilization, with representatives present during cases to ensure proper training and familiarity with the product [38]