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]

Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, a decrease from $14.2 million in Q4 2023, with year-to-date losses amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The company reported a 44% growth in Q4 and 59% operational growth for the full year, driven by the success of the TriNav device [11][27] - The number of unique ordering accounts increased by 43% year-over-year, from 199 to 284, with account utilization improving by 10% [13][14] - The launch of new products, including the TriNav LD infusion system and TriGuide guiding catheter, expanded the PEDD portfolio [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened [28] - The company reported a robust gross margin profile of 85% in Q4 2024, down from 90% in Q4 2023, but maintained an overall gross margin of 86% for the full year [29] Company Strategy and Development Direction - The company is focusing on expanding its PEDD technology into new clinical applications while reducing R&D expenses to achieve EBITDA positivity by mid-2025 [10][11] - Strategic partnerships are being sought to advance the nelitolimod program, particularly in uveal melanoma liver metastases [19] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive EBITDA and cash flow in the second half of the year [22][23] - The company acknowledged the challenges posed by the economic environment but emphasized strong commercial momentum and a clear path to growth [10][11] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors in stock-based compensation and R&D expense timing [25][26] Q&A Session Summary Question: Uptake of TriNav large vessels in TACE and TARE procedures - Management noted increased use in TARE more than TACE, particularly for larger vessel applications [37][39] Question: Current mapping with TARE and new CMS code impact - The new CMS code allows for mapping and treatment in Medicare patients, opening up about 25% of the market previously not accessible [46][72] Question: Insights on PERIO-03 data - The Phase I study is focused on safety and technology success, with results expected mid-2025 [50][52] Question: Guidance for Q1 and year cadence - Management indicated that while growth may not be uniform, they remain optimistic about achieving the 50% growth target for the year [61][98] Question: Account openings and utilization strategy - The company is shifting focus from opening new accounts to driving utilization in existing accounts, with a balanced approach moving forward [65][66] Question: Mapping attachment rate in commercial cases - Management believes the mapping attachment rate is close to one-to-one in commercial cases, emphasizing better outcomes with the same technology [81][82] Question: Next steps for pancreatic trials - A Phase II or III trial is likely, with potential for partnership, pending data from ongoing studies [88] Question: Status of 10-K filing delay - The audit is ongoing, and management is committed to transparency regarding any changes in financial results [91][92]