Trisalis Life Sciences (TLSI) Q3 2025: Mapping Drives 30% of Growth as TriNav Platform Broadens Clinical Reach
Trisalis Life Sciences accelerated market penetration in Q3, with expanded reimbursement and new product launches fueling adoption across complex embolization procedures. Mapping applications now contribute a material share of growth, and the company is leveraging its PEDD platform to address large, adjacent markets beyond liver cancer. Management reaffirmed strong revenue guidance and signaled operational improvements for the balance of the year, setting up a pivotal 2026 as new indications come online.
Summary
- Mapping Applications Now Drive Material Share: Mapping procedures contributed about 30% of recent growth, reshaping TriNav’s case mix.
- Product Portfolio Expansion Accelerates Adoption: TriNav Flex and XP launches are broadening addressable markets and deepening account utilization.
- Operational Leverage Expected in Q4: Margin headwinds from new launches are set to ease as manufacturing stabilizes, supporting EBITDA targets.
Performance Analysis
Trisalis delivered robust Q3 revenue growth, with sales reaching $11.6 million, representing a 57% year-over-year increase and a 3% sequential gain. This top-line momentum reflects both increased account penetration and broader procedural utilization of the TriNav platform, especially after the introduction of the CMS HCPCS code C8004, which doubled reimbursable indications in radioembolization. The number of unique ordering accounts grew by 30% year-over-year, adding 20 new accounts, while utilization per account also rose.
Gross margin slipped to 84% from 86% a year ago, primarily due to manufacturing inefficiencies associated with newly launched products. R&D expenses were elevated by a one-time $2.1 million charge tied to clinical study closures, while sales and marketing spend increased in line with commercial momentum. Despite these investments, cash burn improved substantially to $3.8 million, and quarter-end liquidity stood at $22.7 million, providing ample runway for strategic initiatives.
- Account Penetration Deepens: Utilization per account is rising as more physicians within each site adopt TriNav for multiple indications.
- Mapping Drives Upside: Mapping procedures now represent roughly 30% of growth, primarily in radioembolization, enabled by new reimbursement.
- Gross Margin Pressure Temporary: New product launches and SKU complexity drove short-term margin dilution, but normalization is expected in Q4 as production stabilizes.
Adjusted EBITDA loss narrowed meaningfully year-over-year, reflecting disciplined expense management and sales growth. Management expects further improvement as one-time R&D and G&A charges roll off and manufacturing efficiency rebounds.
Executive Commentary
"Our commercial momentum in the third quarter remained strong. The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and Medicaid Services, CMS, HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using Trinav, enabling interventional radiologists to utilize Trinav for other treatment planning and delivery using radioembolization. As a result, the reimbursable use of our technology within the radioembolization market has effectively doubled, supporting the broader adoption we're observing."
Mary Zella, President and Chief Executive Officer
"Our cash burn for the quarter was approximately $3.8 million, bringing our quarter-end cash and cash equivalence balance to $22.7 million. We believe this provides us ample liquidity to fund our operations and strategic objectives. Subsequent to the quarter, we amended our debt agreement to reduce the minimum cash covenant from $10 million to $5 million, providing additional balance sheet flexibility."
David Patience, Chief Financial Officer
Strategic Positioning
1. Platform Expansion Beyond Liver Indications
TriNav, pressure-enabled drug delivery (PEDD) platform, is being leveraged to address new indications beyond liver cancer, including uterine fibroids, thyroid nodules, and genicular artery embolization (GAE) for knee osteoarthritis. Early clinical feedback and registry data suggest strong technical success and patient outcomes, positioning TriNav as a versatile solution for complex vascular interventions.
2. Reimbursement-Driven Adoption
The introduction of the CMS HCPCS code C8004, a procedural reimbursement code, has doubled the reimbursable use of TriNav in radioembolization. This has enabled interventional radiologists to use TriNav for both mapping and treatment, driving a “two for one” dynamic in radioembolization cases and materially expanding the addressable market.
3. Product Portfolio Innovation
Recent launches of TriNav Flex, LV, and XP have broadened the procedural applicability of the platform, addressing varied vessel sizes and anatomical challenges. TriNav Flex now comprises about 35% of the product mix, and XP is seeing robust uptake in market evaluation for uterine artery embolization. New SKUs are enabling deeper account penetration and higher utilization per physician.
4. Commercial Model Focused on Utilization Growth
The sales strategy has shifted from new account openings to increasing utilization within existing accounts, supported by peer-to-peer education and expanded procedural offerings. The company segments accounts by readiness and invests in physician education to accelerate ramp in “cold” accounts while driving deeper use in mature sites.
5. Capital Structure Simplification and Liquidity Management
Completion of the preferred stock exchange and debt covenant amendment have streamlined the capital structure, eliminated reset provisions, and enhanced balance sheet flexibility. Lower cash burn and ample cash reserves support ongoing investment in commercial and clinical initiatives.
Key Considerations
Trisalis is executing a multi-pronged growth strategy, balancing commercial expansion, product innovation, and clinical evidence generation while managing operational complexity and capital discipline.
Key Considerations:
- Mapping Reimbursement Impact: Expanded procedural reimbursement is catalyzing adoption, but education and process change remain gating factors for full uptake.
- Portfolio Complexity and Manufacturing: Rapid SKU proliferation is creating short-term manufacturing inefficiencies, but normalization is expected as volumes stabilize and physician preferences settle.
- Clinical Data as a Growth Lever: Ongoing registries in thyroid, uterine, and genicular artery embolization will be critical for future market expansion and payer engagement.
- Adjacent Market Opportunity: GAE and uterine artery embolization could rival or exceed the liver market in volume, offering significant long-term upside if clinical and commercial execution deliver.
- Operating Leverage Next Year: As one-time R&D and G&A costs roll off and gross margin recovers, EBITDA break-even becomes more achievable, aligning with management’s stated timeline.
Risks
Key risks include the pace of clinical adoption in new indications, especially given the need for physician education and workflow integration. Manufacturing complexity from rapid SKU expansion could pressure margins if product mix shifts faster than operational scaling. Payer and reimbursement dynamics remain a swing factor as new procedural codes are adopted and payer education continues. Competitive responses in embolization and drug delivery could also intensify as Trisalis moves into larger adjacent markets.
Forward Outlook
For Q4 2025, Trisalis guided to:
- Continued strong revenue growth, tracking to full-year 50% top-line expansion
- Gross margin normalization as manufacturing stabilizes
For full-year 2025, management reaffirmed guidance:
- 50% revenue growth and adjusted EBITDA positivity in the first half of 2026
Management highlighted several factors that will shape results:
- Deeper account utilization and ongoing mapping adoption as key growth levers
- Full commercial launch of TriNav Advance and XP to expand procedural reach
Takeaways
Trisalis is leveraging reimbursement tailwinds and portfolio innovation to drive sustained growth, while managing short-term operational headwinds. Clinical expansion into adjacent markets is set to define the next phase of growth, but execution risk remains as the company scales manufacturing and commercial operations.
- Mapping and new indications are driving a step-change in addressable market size, with early traction in GAE and uterine embolization signaling long-term upside.
- Operational improvements and cost discipline are supporting improved cash flow, even as the company invests in commercial and clinical expansion.
- Investors should watch for evidence of sustained utilization growth, gross margin recovery, and successful launches of new TriNav SKUs as signals of execution quality into 2026.
Conclusion
Trisalis delivered another quarter of strong commercial execution, with mapping reimbursement and product innovation driving broader adoption. As the company pivots to leverage its PEDD platform across multiple high-value indications, operational and clinical execution will be critical to realizing its long-term growth thesis.
Industry Read-Through
The rapid adoption of mapping and procedural reimbursement codes for advanced embolization technologies signals a broader industry shift toward platform-based solutions in interventional oncology and vascular intervention. Competitors in drug delivery and embolization will need to accelerate innovation and build clinical evidence to match the expanding clinical utility and economic value proposition demonstrated by TriNav. Reimbursement dynamics and physician workflow integration will remain key battlegrounds as the sector moves toward minimally invasive, precision-guided therapies across multiple organ systems.