Financial Data and Key Metrics Changes - Fourth quarter revenues were $13.2 million, representing a 60% increase year-over-year, while full-year revenues were $45.2 million, a 53% increase compared to the previous year [5][21] - Gross margin for the fourth quarter improved to 87% from 85% in the prior year, driven by better manufacturing efficiency [21] - Net operating loss for the quarter was $3.3 million, down from $7.6 million in the prior year, reflecting increased revenue and margin contribution [22] - Adjusted EBITDA loss for the quarter was approximately $950,000, an improvement from a loss of $5.7 million in the prior year [22] Business Line Data and Key Metrics Changes - Revenue from the TriNav system for the year was $45 million, a 53% increase compared to the previous year, primarily driven by increased sales in liver-directed therapies [23] - Research and development expenses decreased by $2.7 million for the year, mainly due to the closeout of clinical trial expenses related to nelitolimod [24] - Sales and marketing expenses increased by $2.9 million for the year, attributed to higher performance-related compensation due to increased sales [24] Market Data and Key Metrics Changes - The total addressable market for liver embolization procedures is approximately $480 million, while the broader embolization market represents a $2.3 billion opportunity [13][14] - The introduction of a new CMS HCPCS code expanded coverage for simulation or mapping procedures using TriNav, effectively doubling the reimbursable use of the technology [14][15] Company Strategy and Development Direction - The primary strategic priority is to expand sales and commercial infrastructure, with plans to double the commercial footprint and enhance clinical studies to validate the PEDD platform [7][9] - The company aims to launch TriNav Advance in the first half of 2026, which is expected to facilitate selective therapy delivery to small distal vessels [13] - The strategy includes conducting foundational studies to prove the superiority of the technology in liver embolization, which is expected to drive long-term penetration in the market [55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue guidance of $60 million to $62 million for 2026, with growth weighted towards the second half of the year [9][19] - The company noted strong physician engagement and interest in the PEDD platform, indicating a positive outlook for future demand [10] - Management emphasized the importance of investing in commercial infrastructure and clinical evidence to support long-term growth [7][20] Other Important Information - The company raised $46 million in gross proceeds through a public offering, which was oversubscribed and supported by experienced healthcare investors [6][26] - The company is focused on executing near-term milestones, including launching TriNav Advance and publishing clinical data across various indications [19][20] Q&A Session Summary Question: Contribution from liver versus non-liver growth in 2026 - Management indicated that liver will still be the majority of revenue in 2026, with expectations for meaningful progress in non-liver applications tied to data releases later in the year [28][29] Question: Balancing growth cadence and EBITDA pathway - Management stated that specific timing or guidance on cash flow breakeven or adjusted EBITDA breakeven is not being provided at this time, as investments in commercial expansion are ongoing [30] Question: Details on the sales organization structure after investments - Management confirmed that the commercial organization will be significantly expanded, including adding a layer of management to improve sales opportunities [34][35] Question: Growth expectations for mapping and simulation - Management expressed confidence in growth from mapping and simulation, particularly with the introduction of new products like TriNav XP and TriNav Advance [40][41] Question: Use patterns for the TriNav product portfolio - Management noted varied use patterns among physicians, with some preferring specific products while others seek access to the full portfolio for clinical flexibility [48][52] Question: Long-term opportunities for TriNav in liver versus non-liver - Management highlighted that liver will remain a significant component of sales, but there are substantial growth opportunities in non-liver applications, particularly in thyroid artery embolization [54][56]