Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $11.6 million, representing a 57% increase year-over-year and a 3% sequential gain over Q2 2025 [5][16] - Gross margin for the quarter was 84%, down from 86% in the prior year, primarily due to lower manufacturing efficiency associated with newly launched products [17] - Operating loss for the quarter was $9 million, compared to $8.7 million in the prior year, driven by one-time charges related to clinical studies [18] - Cash used in operations was $3.7 million, a significant improvement from $11.2 million in Q3 2024 [19] - Adjusted EBITDA loss improved to $5.4 million from $7.1 million in the prior year [19] Business Line Data and Key Metrics Changes - The commercial organization increased the number of unique ordering accounts by 30% compared to Q3 2024, adding 20 new accounts [16] - The reimbursement use of TriNav technology within the radioembolization market has effectively doubled due to the introduction of a new CMS code [6][7] - The company launched the TriNav Flex infusion system and advanced new clinical applications to expand market opportunities [5][6] Market Data and Key Metrics Changes - The company is experiencing strong commercial momentum in the complex liver embolization market, supported by the new CMS HCPCS code C8004 [6][7] - Early feedback from key accounts indicates strong clinical and economic advantages from the expanded reimbursement, expected to drive adoption into 2026 [7] Company Strategy and Development Direction - The company is focused on expanding its TriNav platform and investing in long-term growth through increased commercial resources and funding for new applications [6][8] - Trisalus aims to leverage its pressure-enabled drug delivery (PEDD) technology across a wide range of solid tumors and interventional treatment approaches [8][15] - The company is also preparing to launch a clinical trial evaluating TriNav and genicular artery embolization (GAE) for knee osteoarthritis [12][43] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed a 50% revenue growth guidance, reflecting confidence in growth momentum and market opportunities [7][21] - The company is excited about the current momentum, especially in Q4, and is focused on maintaining its growth trajectory [21][27] - Management highlighted the potential of GAE as a significant market opportunity, potentially rivaling the liver market [42][43] Other Important Information - The company simplified its capital structure through a successful exchange offer and consent solicitation for preferred stock [6] - Cash and cash equivalents at the end of the quarter were $22.7 million, providing ample liquidity for operations and strategic objectives [19] Q&A Session Summary Question: Insights on 2026 growth expectations - Management is confident about current momentum and maintaining guidance of 50% growth and adjusted EBITDA positivity in the first half of next year [21] Question: Growth in other indications outside liver - The company is investing in new applications, particularly in uterine artery embolization, which is expected to reduce procedural time and pain [22] Question: Gross margin outlook - Management expects an uptick in gross margins in Q4 as manufacturing efficiencies improve [33] Question: Adoption of new products - The TriNav Flex has been well received, with significant adoption in selective treatments and larger territory treatments [38] Question: Utilization trends for accounts launched at different times - Accounts launched 18 months ago continue to improve month over month, with faster ramps for those familiar with the technology [44]