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, reflecting a 53% increase compared to the previous year [6][26] - Gross margin for the fourth quarter improved to 87% from 85% in the prior year, driven by better manufacturing efficiency [24] - Net operating loss for the quarter was $3.3 million, a significant decrease from $7.6 million in the prior year [25] - Adjusted EBITDA loss for the quarter was approximately $950,000, an improvement from a loss of $5.7 million in the prior year [25] Business Line Data and Key Metrics Changes - Revenue from the TriNav system for the full year was $45 million, a 53% increase compared to the previous year, primarily driven by increased sales in liver-directed therapies [26] - Research and development expenses decreased by $2.7 million for the year, mainly due to the closeout of clinical trial expenses related to nelitolimod [27] - Sales and marketing expenses increased by $2.9 million for the year, attributed to higher performance-related compensation due to increased sales [28] Market Data and Key Metrics Changes - The total addressable market for liver embolization procedures is approximately $480 million, while the broader embolization market, including thyroid and uterine artery embolization, represents a $2.3 billion opportunity [15][16] - The introduction of the CMS HCPCS code C8004 expanded coverage for simulation or mapping procedures using TriNav, effectively doubling the reimbursable use of the technology [16] Company Strategy and Development Direction - The primary strategic priority is to expand sales and commercial infrastructure, with plans to nearly double the commercial footprint [9][10] - The company is investing in foundational clinical studies to validate the Pressure-Enabled Drug Delivery (PEDD) platform, which is expected to drive growth in 2027 and beyond [9] - The product portfolio is expanding from two core products at the beginning of 2025 to seven differentiated offerings by 2026, enhancing sales productivity [12] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed revenue guidance for 2026 in the range of $60 million to $62 million, with growth expected to be weighted towards the second half of the year [9][22] - The company anticipates that the significant investment in the sales force will lead to stronger productivity and revenue growth exiting 2026 [10] - Management emphasized the importance of clinical data releases in driving adoption of new applications, particularly in non-liver areas [33][60] Other Important Information - The company raised $46 million in gross proceeds through a public offering, which was oversubscribed and supported by experienced healthcare investors [8][30] - The company is awaiting FDA clearance for the TriNav Advance product, which is expected to enhance therapeutic delivery and expand market opportunities [15][49] Q&A Session Summary Question: Contribution to growth in 2026 from liver versus non-liver - Management indicated that liver will still be the majority of revenue in 2026, but expects meaningful progress in new applications tied to data releases in the second half of the year [33] Question: Balancing growth cadence and EBITDA pathway - Management is not providing specific timing on cash flow or adjusted EBITDA breakeven but is focused on investments to scale the company meaningfully [34][35] 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 effectiveness [39][40] Question: Growth expectations for mapping and simulation - Management expressed confidence in growth from TriNav XP and TriNav Advance, which are expected to enhance mapping capabilities [46][48] 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 [52][56] Question: Long-term opportunities for TriNav in liver versus non-liver - Management highlighted that liver will remain a significant component of sales, but sees substantial growth potential in thyroid artery embolization and other new applications [60][62]

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, reflecting a 53% increase compared to the previous year [6][26] - Gross margin for the fourth quarter improved to 87% from 85% in the prior year, driven by better manufacturing efficiency [24] - Net operating loss for the fourth quarter was $3.3 million, a significant decrease from $7.6 million in the prior year [25] - Adjusted EBITDA loss for the quarter was approximately $950,000, an improvement from a loss of $5.7 million in the prior year [25] Business Line Data and Key Metrics Changes - Revenue from the TriNav system for the full year was $45 million, a 53% increase compared to the previous year, primarily driven by increased sales in liver-directed therapies [26] - Research and development expenses decreased by $2.7 million for the year, largely due to the closeout of clinical trial expenses related to nelitolimod [27] - Sales and marketing expenses increased by $2.9 million for the year, attributed to higher performance-related compensation due to increased sales [28] 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 U.S. addressable market [15][16] - The introduction of a new CMS HCPCS code expanded coverage for simulation or mapping procedures, effectively doubling the reimbursable use of the technology [16] 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 [9][10] - The company aims to launch TriNav Advance in the first half of 2026, which is expected to facilitate selective therapy delivery and enhance therapeutic delivery to tumors [15] - The company is focused on executing near-term milestones, including achieving annual revenue in the range of $60 million-$62 million for 2026 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term value of the PEDD platform and the growth opportunities ahead, despite the need for upfront investments affecting near-term revenue [10][11] - The company anticipates that the revenue cadence will build throughout 2026 as the commercial expansion and new product contributions progress [10] - Management highlighted strong physician engagement and interest in the PEDD platform, indicating a positive outlook for future adoption [10] Other Important Information - The company raised $46 million in gross proceeds through a public offering, which was oversubscribed and supported by experienced healthcare investors [8] - The company is preparing to release a consolidated clinical update for the nelitolimod program in the second half of 2026, focusing on presenting a complete dataset for potential partners [21] Q&A Session Summary Question: Contribution to growth in 2026 from liver versus non-liver - Management indicated that liver will still be the majority of revenue in 2026, with expectations for meaningful progress in new applications in the second half of the year [33] 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 they are in the early stages of investing in commercial expansion [34] Question: Details on the sales organization structure after investments - Management confirmed that they are significantly doubling the size of the commercial organization and adding a layer of management to improve sales opportunities [38] 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 [44] 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 [50]

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]

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]

TriSalus Life Sciences Conference Call Summary Company Overview - **Company**: TriSalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving drug delivery to pancreatic, liver, and solid tumors, with a specific emphasis on a drug called nelitolimod, an immunotherapeutic aimed at reversing immunosuppression in tumors [2][3] Industry Insights - **Uterine Fibroids**: The call highlighted uterine fibroid embolization as a preferable alternative to surgery for patients suffering from uterine fibroids [2][10] - **Interventional Radiology (IR)**: The field has evolved significantly, with IR now recognized as a primary specialty in medicine, performing minimally invasive procedures using image guidance [12] Key Technology and Innovations - **Pressure-Enabled Drug Delivery**: TriSalus's technology modulates pressure and flow to enhance therapeutic delivery to tumors while minimizing exposure to normal tissues [3][5] - **TriNav Infusion System**: A proprietary system designed to improve the delivery of therapeutic agents, particularly in uterine artery embolization [8][10] - **Smart Valve Technology**: This technology allows for better perfusion of drugs into tumors by opening collapsed vessels and enhancing blood flow [5][6] Clinical Evidence and Outcomes - **Uterine Artery Embolization (UAE)**: - UAE is effective for treating uterine fibroids and adenomyosis, providing significant symptomatic relief and a minimally invasive option compared to traditional surgical methods [16][19] - Clinical data showed that UAE is as effective as surgical alternatives, with a slightly higher re-intervention rate [19] - A study indicated a 100% technical and clinical success rate in patients using the TriNav catheter, with significant reductions in heavy menstrual bleeding and pain scores [26][27] Market Dynamics - **Awareness and Education**: There is a lack of awareness among patients and healthcare providers regarding UAE, with many women unaware of this treatment option [17][50] - **Referral Pathways**: Improved collaboration between interventional radiologists and gynecologists is essential to enhance patient access to UAE [50][53] - **Cost-Effectiveness**: The TriNav technology has been shown to be cost-saving due to reduced complications and improved therapeutic delivery, which is appealing to payers [65] Future Directions - **Patient Education Initiatives**: TriSalus plans to enhance patient education through social media and direct outreach to improve awareness of UAE [55][56] - **Research and Data Publication**: Ongoing efforts to publish clinical data supporting the efficacy of TriSalus's technologies will help influence treatment decisions among patients and providers [58] Conclusion TriSalus Life Sciences is positioned to make significant advancements in the treatment of uterine fibroids and solid tumors through innovative drug delivery technologies and a focus on patient education and awareness. The company aims to bridge the gap between interventional radiology and gynecology to improve patient outcomes and expand the adoption of minimally invasive procedures.