Summary of TriSalus Life Sciences Conference Call Company Overview - **Company**: TriSalus Life Sciences (NasdaqGM: TLSI) - **Industry**: Oncology medical technology - **Technology**: Pressure-enabled drug delivery system designed to enhance drug delivery to tumors while minimizing exposure to normal tissues [2][6] Core Points and Arguments - **Market Opportunity**: The microcatheter market is valued at $2.5 billion, with TriSalus focusing primarily on liver applications, holding less than 10% market share, indicating significant growth potential [2][8] - **Growth Rate**: The company has experienced a growth rate of 50% annually with an 85% gross margin [2][8] - **Clinical Benefits**: The technology has shown to increase drug delivery to tumors by 40%-500%, leading to improved patient outcomes and reduced hospital readmission rates by 50% [5][7] - **Reimbursement**: TriSalus has secured favorable reimbursement codes from CMS, which are permanent and unique to their technology, enhancing economic viability for hospitals [7][8][31] - **Device Variants**: The company offers multiple device configurations (TriNav, TriNav Large, TriNav Flex) tailored to different patient anatomies [5][8] Additional Applications - **Uterine Fibroids**: The technology has been adapted for treating uterine fibroids, providing a less invasive option compared to surgery [9][10] - **Multinodular Goiter**: TriSalus is exploring applications for treating thyroid nodules, which can be accessed via a less invasive route [11][12] - **Pancreatic Cancer**: The company is developing a device for pancreatic cancer treatment, utilizing venous anatomy for drug delivery [13][14] - **Genicular Artery Embolization**: A new application for osteoarthritis treatment is being explored, with promising initial results [15][16] Financial Performance - **Q3 Earnings**: Reported earnings of $11.6 million, with expectations for a strong Q4 due to year-end spending [16][18] - **Operational Expenses**: Targeting $14 million in GAAP operational expenses, with a focus on maintaining sales and marketing efficiency [24][25] - **Sales Strategy**: The focus is on increasing utilization within existing accounts rather than acquiring new accounts, leveraging recent product iterations [20][26] Future Outlook - **Product Launches**: Anticipated launch of new technology in December, aimed at enhancing physician adoption without requiring a switch from existing microcatheters [17][30] - **Clinical Studies**: Ongoing clinical studies to support the efficacy of the technology across various applications, with plans for registry studies to gather robust data [27][29] - **Reimbursement Impact**: The introduction of mapping codes has resulted in a 30% increase in business, highlighting the importance of training hospitals for billing [31][32] Important but Overlooked Content - **Patient-Centric Approach**: The technology not only improves clinical outcomes but also reduces the need for long-term therapies, such as thyroid replacement, which can significantly enhance patient quality of life [12][15] - **Grassroots Adoption**: Many new applications have emerged from physician-led initiatives, indicating a strong grassroots demand for the technology [23][27] - **Cost Savings**: The technology has been shown to reduce overall procedure costs, providing additional financial incentives for hospitals [33]

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]