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]

Financial Data and Key Metrics Changes - CGuard revenue for Q1 2025 reached $1,530,000, reflecting a 1.2% year-over-year growth [5][21] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [21] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 in Q1 2025 compared to Q1 2024 [21] - Net loss for Q1 2025 totaled $11,166,000 or $0.22 per share, compared to a net loss of $7,032,000 or $0.21 per share in the same period in 2024 [21] Business Line Data and Key Metrics Changes - CGuard stent sales totaled 2,611 units in Q1 2025, contributing to a total of approximately 64,000 implants sold to date [5][6] - Anticipated U.S. approval and launch of CGuard Prime is expected in Q3 2025, with preparations underway for a significant demand [6][7] Market Data and Key Metrics Changes - The U.S. market for carotid artery disease treatments is shifting towards endovascular procedures, with a significant conversion from surgery to stenting expected [8][12] - The introduction of CGuard Prime is anticipated to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales benchmarks [8][12] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, aiming for robust growth driven by the launch of CGuard Prime and the Switchgard neuroprotection system [9][19] - A state-of-the-art facility in Miami, Florida, is being established to support U.S. operations and meet market demand efficiently [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for CGuard Prime and highlighted the importance of building a strong commercial team to support the launch [6][30] - The company remains engaged with the FDA and is optimistic about the approval timeline, despite some delays due to agency processes [30][40] Other Important Information - The company has received FDA approval for the investigational device exemption for the CGuardians two pivotal study, with strong enrollment progress [16][33] - The company is also advancing its TCAR strategy with plans for a fully integrated TCAR solution, anticipating FDA clearance in late 2026 [17][36] Q&A Session Summary Question: Update on CGuard Prime FDA approval timeline - Management explained that the timeline was adjusted due to the scheduling of the facility site audit and subsequent feedback from the FDA, but they remain confident in achieving approval [30][40] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive regarding the use of CGuard Prime [33] Question: Update on Switchgard and FDA engagement - The company has resubmitted its IDE to the FDA, with a revised timeline for clearance expected in late 2026 [36] Question: Impact of FDA changes on review team and timelines - Management confirmed that the review team remains intact and interactions with the FDA are positive, despite some delays [40] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval, ensuring a strong foundation is in place for the product launch [44] Question: Expectations for CREST two trial results - Management indicated that the results will depend on the severity of the enrolled patients, with expectations that it may not change current practices significantly [52]

Financial Data and Key Metrics Changes - CGuard revenue reached a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% growth year-over-year, with $7 million in revenue for the full year 2024 [7][22] - Gross profit for Q4 2024 decreased by $36,000 or 7.1% to $469,000, compared to $505,000 for Q4 2023, primarily due to increased cost of goods sold [19][20] - Net loss for Q4 2024 totaled $9.1 million or $0.19 per share, compared to a net loss of $5.4 million or $0.16 per share for the same period in 2023 [22] - Total revenue for the full year 2024 increased 13% to $7 million from $6.2 million in 2023 [22] - Gross margin decreased to 21.5% for the full year 2024 from 29.1% in 2023 [24][25] Business Line Data and Key Metrics Changes - CGuard stents sold for Q4 2024 totaled 3,512 units, contributing to 12,100 units sold for the full year [7] - The company has sold over 60,000 implants to date, indicating a strong global commercial foundation [7] Market Data and Key Metrics Changes - The company estimates that more than 7,000 US TCAR procedures were performed in Q4, with global unit sales close to 50% of the US-only TCAR market [8] - The anticipated US market entry of both CAS and TCAR platforms is expected to significantly expand revenue upon regulatory approval [9] Company Strategy and Development Direction - The company is focused on the anticipated US launch of CGuard Prime in the first half of 2025, with a robust commercial and operational launch plan [10][11] - The new headquarters in Miami, Florida, is strategically positioned to support the US launch and commercialization of CGuard Prime [11] - Ongoing investments in both CAS and TCAR are aimed at serving a broad physician base and leading product innovation [16] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the first half approval for CGuard Prime, citing productive interactions with the FDA [34] - The company is not providing forward-looking revenue guidance but is optimistic about growth following potential US FDA approval [26][27] Other Important Information - The CGUARDIANS pivotal clinical trial demonstrated a major adverse events rate of just 0.95% through 30 days and 1.95% through 12 months post-procedure, the lowest event rate reported in a pivotal study of carotid stent or embolic protection device [13] - The company is preparing for a significant increase in operating expenses due to hiring and clinical trial costs [59] Q&A Session Summary Question: US approval timing for CGuard Prime - Management remains optimistic about first half 2025 approval and has had productive discussions with the FDA [34] Question: CGUARDIANS II and III enrollment and timing - Enrollment for CGUARDIANS II is going well, and the timeline for integration into the competitor neuroprotection system is still tracking for early 2026 [37] Question: High-level business outlook for 2025 - The international business continues to grow, and the second half of 2025 will be a foundational building time post-approval [45] Question: Commercial launch process and adoption expectations - Hospitals will not consider a product until it is approved, but the company is preparing for launch by holding its place in line for VAC reviews [53] Question: Operating expenses growth throughout 2025 - Significant growth in operating expenses is expected due to the expansion of the sales organization and ongoing clinical trials [59]