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]