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]

Financial Data and Key Metrics Changes - The company reported net sales of $11,200,000 for Q2 2025, representing a 52% increase compared to Q2 2024 and a 22% sequential gain over Q1 2025 [8][21] - Gross margin for the quarter was 84%, down from 88% in 2024, primarily due to lower manufacturing efficiency associated with newly launched products [22] - Operating losses for Q2 2025 were $7,300,000, an improvement from $8,200,000 in 2024 [25] - Adjusted EBITDA loss for Q2 2025 was $5,300,000, compared to $6,700,000 in 2024, attributed to increased sales and reduced R&D expenses [26] Business Line Data and Key Metrics Changes - The company launched the TriNavFlex infusion system and reported strong initial sales exceeding internal projections [12] - The number of unique ordering accounts increased by 28% year over year, with a 10% increase quarter over quarter [21][42] - The TriNav product portfolio is expanding, with new devices aimed at addressing complex clinical scenarios [10][12] Market Data and Key Metrics Changes - The company gained further penetration in the complex liver embolization market, supported by the issuance of HCPCS code C8004, which allows for reimbursement of simulation or mapping procedures using TriNav [11] - The company is focusing on expanding its market opportunity through new clinical applications and partnerships [10] Company Strategy and Development Direction - The strategic priorities include driving adoption of the Pressure Enabled Drug Delivery (PEDD) platform, advancing new clinical applications, and improving operational performance [10][20] - The company is transitioning to a partnership-focused approach for nalotolimod, which will eliminate development-related expenses while preserving long-term value [14] - The company aims to become cash flow positive by early 2026, with a focus on device innovation and expanding the clinical body of evidence [26][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 50% revenue growth for the year, emphasizing the importance of operational performance and strategic investments [19] - The company is optimistic about the growing momentum across its programs and the potential for TriNav to become the standard of care in liver embolization [13][20] Other Important Information - The company completed a $22,000,000 private placement, strengthening its balance sheet and providing resources for further investment in its commercial strategy [8][26] - The exchange offer and consent solicitation for preferred stock were successfully completed, simplifying the capital structure [27] Q&A Session Summary Question: Discussion on the new mapping code and its market reception - Management highlighted the importance of the new mapping code for reimbursement, which has increased physician confidence in using the technology for both mapping and treatment [30][32] Question: Operating expense outlook - Management indicated a focus on reducing operating expenses, particularly in general and administrative costs, while maintaining investment in sales and marketing [36][38] Question: Unique ordering accounts and commercial organization investments - Unique ordering accounts were up 28% year over year, with a focus on increasing utilization per account through enhanced sales strategies [42][46] Question: Contribution of new products to revenue - The TriNav Large product contributed approximately 10% to 15% to revenue, while the newly launched TriNav Flex is exceeding expectations [49][50] Question: Impact of thyroid data publication on adoption - The publication of data on thyroid procedures is generating significant interest among physicians, with expectations for increased adoption in the coming years [54][56] Question: Third quarter revenue expectations - Management expressed confidence in achieving low double-digit growth in the next two quarters, aligning with the overall guidance of 50% revenue growth for the year [56][58]

Financial Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [9][23] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [24] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [25] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, compared to losses of $10.4 million in Q1 2024 [27] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% year-over-year, adding 32 new accounts in Q1 2025 [11][12] - The launch of TriNav Large and TriGuide expanded the PEDD technology into larger vessels, supporting deeper penetration in the liver market [15] Market Data and Key Metrics Changes - Trisalis has achieved a market share of 10% in liver taste and tear procedures, reflecting growth driven by the adoption of TriNav in new accounts and increased utilization [23] - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNet, effectively doubling the reimbursable use of the technology [12] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav Flex and TriNav Large, and generating new health economic and outcome research data [19][20] - A shift to a partnership-focused strategy for nalotolimod is expected to eliminate development expenses while preserving long-term value [9][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [20] - The company is optimistic about the momentum built from recent strategic initiatives and the potential for new clinical applications [19][21] Other Important Information - Trisalis raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for future investments [18][27] - The company is implementing an exchange offer to convert preferred shares to common stock, simplifying its capital structure [18] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [36] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management clarified that nalotolimod's optimal delivery is through their technology, and they expect to partner with pharmaceutical companies for combined trials [40] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among larger tumors and uterine fibroid embolization, with positive results reported by physicians [46] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [50] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [55] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [58] Question: Commercial organization expansion and account numbers? - The company currently has around 300 accounts and aims to expand its sales force to 60-70 representatives over the next 18 months [79]

Financial Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [8][22] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [23] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [24] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, down from $10.4 million in Q1 2024, reflecting improved sales and reduced expenses [25] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% compared to Q1 2024, adding 32 new accounts [10] - The TriNav device's market share in liver procedures reached 10%, with a compound annual growth rate of approximately 50% since its launch in 2020 [22] Market Data and Key Metrics Changes - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNav, effectively doubling the reimbursable use of the technology [11] - The company is expanding its technology into new clinical settings, including a multicenter registry evaluating PEDD for patients with thyroid nodules [13] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav technology, and preparing nalotolimod for pharmaceutical partnerships [7][18] - Strategic priorities include driving adoption of PEDD across solid tumors, improving manufacturing and gross margins, and expanding the product portfolio [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [19] - The company is entering the rest of 2025 with strong tailwinds and plans to invest in strategic areas to drive long-term value [19][20] Other Important Information - The company raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for further investments [16] - The completion of Phase I trials for nalotolimod allows the company to shift to a partnership-focused strategy, reducing development expenses [15] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [30][34] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management indicated that nalotolimod's performance is optimized through their technology, and they expect to partner with pharmaceutical companies for combined development [35][38] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among physicians treating larger tumors, with positive results reported [41][43] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [45][46] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [50][51] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [52][54] Question: What is the current number of accounts and future goals? - The company has around 300 accounts and aims to increase its sales force to cover more hospitals [73][76]