Trisalis Life Sciences (TLSI) Q2 2025: TriNavFlex Launch Fuels 52% Revenue Surge and Expands Clinical Reach
Trisalis Life Sciences delivered accelerated growth in Q2, propelled by the TriNavFlex launch and a broadened clinical footprint. The company’s pressure-enabled drug delivery (PEDD) platform gained momentum in both established and emerging indications, while a strategic pivot away from in-house drug development is streamlining costs and sharpening focus. With new reimbursement codes, portfolio expansion, and a simplified capital structure, Trisalis is positioning for sustained commercial and operational leverage into 2026.
Summary
- TriNav Platform Expansion: Broadened portfolio and new reimbursement codes are accelerating device adoption in complex clinical settings.
- Cost Structure Reset: Exit from internal drug development and operating expense discipline are driving improved EBITDA trajectory.
- Commercial Focus Intensifies: Execution pivots to account utilization and physician engagement to sustain growth into 2026.
Performance Analysis
Trisalis posted robust top-line growth in Q2, with net sales of $11.2 million, up 52% year over year and 22% sequentially, reflecting strong commercial traction for the TriNav product suite. The company reported a 28% year-over-year increase in unique ordering accounts, with sequential gains driven by both new account openings and deeper penetration in existing accounts. Gross margin moderated to 84%, down from 88% a year ago, as manufacturing efficiency lagged with the ramp of new products, but management expects improvement as scale builds in the second half.
Operating loss narrowed to $7.3 million from $8.2 million in the prior year, aided by higher sales and lower R&D expense following the wind-down of internal drug development. Adjusted EBITDA loss improved to $5.3 million, with the company on track for cash flow positivity in early 2026. The $22 million private placement and preferred share exchange further bolstered liquidity and simplified the capital structure. Sales and marketing investment rose to $7.2 million, reflecting ongoing expansion of the commercial team and infrastructure to support future growth.
- Device Utilization Growth: TriNavFlex and TriNav LV launches are expanding addressable cases and driving higher per-account usage.
- Reimbursement Tailwind: New CMS code C8004 is doubling reimbursable use for mapping and treatment, supporting broader adoption.
- R&D Spend Down: Nelotolimod program wind-down is materially reducing R&D run rate, freeing capital for device innovation.
With robust sales momentum, a more focused operating model, and a strengthened balance sheet, Trisalis is executing on multiple levers to sustain growth and move toward profitability.
Executive Commentary
"We are advancing partnership discussions for Nelitolamide to support its development across several high-value oncology indications. These initiatives are central to unlocking long-term value and we're encouraged by the growing momentum across our programs."
Mary Zella, President and Chief Executive Officer
"We have sufficient liquidity to fund operations throughout 2025 and expect to become cash flow positive in early 2026. The reduction in operating losses were due to increased sales and reduced R&D expense associated with the ramp down of Nella Tolomod clinical trial spending."
David Patience, Chief Financial Officer
Strategic Positioning
1. TriNav Portfolio Expansion and Clinical Penetration
The TriNav platform, a pressure-enabled drug delivery (PEDD) device suite, is now addressing a broader range of solid tumor types and complex vascular anatomies. The launch of TriNavFlex, engineered for tortuous vessels, and TriNav LV for larger vessels, is enabling Trisalis to capture missed case opportunities and increase procedural confidence among interventional radiologists. Early Flex sales are exceeding expectations, and management sees the expanded product suite as a key driver for growth in the back half of 2025 and beyond.
2. Reimbursement and Market Access Acceleration
The introduction of CMS code C8004 for mapping procedures allows clinicians to use TriNav for both simulation and treatment, effectively doubling reimbursable use cases. This is removing adoption barriers and is already driving increased mapping utilization, supported by intensive physician education and coding support via the Z-Health partnership. Reimbursement expansion is a critical enabler for broader adoption and deeper account penetration.
3. Streamlined Cost Structure and Capital Allocation
By shifting Nelotolimod, a TLR9 agonist drug candidate, to a partnership-driven model, Trisalis is eliminating internal development costs and focusing resources on device innovation and commercial execution. This transition is expected to reduce R&D run rate to $2-3 million early next year, with further reductions as the company pivots fully to device-led growth. G&A costs are also targeted for reduction as one-time legal and audit expenses subside.
4. Data Generation and New Indications
Registry studies for new indications (thyroid, genicular artery, uterine fibroid) are building the clinical evidence base needed for future guideline inclusion and commercial expansion. The Protect Registry for thyroid nodules has produced compelling early results, with 100% technical and clinical success, and is generating physician interest nationally. Management expects meaningful thyroid impact in 2026 as data matures and adoption broadens.
5. Commercial Execution and Account Utilization
Trisalis is shifting commercial strategy from account opening to maximizing utilization per account, leveraging physician champions and targeted sales process improvements. Investments in sales leadership and process are designed to drive sustained device usage and build durable relationships with key interventional radiology stakeholders.
Key Considerations
Trisalis is at a commercial inflection, balancing rapid device adoption with operational discipline and a simplified business model. The following considerations are shaping near-term execution and long-term value creation:
Key Considerations:
- Portfolio Breadth Drives Adoption: TriNavFlex and LV launches are addressing clinical gaps and expanding use cases, unlocking new revenue streams.
- Reimbursement as a Growth Lever: The new mapping code is removing friction for physicians and is expected to materially increase procedure volume.
- Resource Reallocation: Pivoting Nelotolimod to external partnership is freeing capital for device innovation and commercial scale-up.
- Operational Leverage in Focus: Margin pressure from new product ramp is expected to ease as manufacturing scales and processes mature.
- Capital Structure Simplification: Preferred share exchange and private placement have aligned the investor base and fortified liquidity for growth initiatives.
Risks
Trisalis faces execution risk as it scales commercial operations and transitions R&D focus to device-led growth. Margin recovery is contingent on manufacturing scale and mix optimization, while success in new indications depends on clinical data and guideline adoption. Market volatility in biotech and device reimbursement policy changes could impact capital access and growth trajectory.
Forward Outlook
For Q3 2025, Trisalis guided to:
- Low double-digit sequential revenue growth, consistent with Q2 trends
- Continued gross margin improvement as manufacturing scales
For full-year 2025, management reiterated guidance:
- 50% revenue growth over 2024
Management highlighted several factors that support the growth outlook:
- TriNavFlex adoption and expanded clinical evidence base are expected to drive higher device utilization
- R&D and G&A run rates will decline as Nelotolimod transitions to partnership and one-time expenses subside
Takeaways
Trisalis is delivering on its commercial strategy, with device innovation, reimbursement expansion, and operational discipline converging to drive sustained growth.
- Commercial Execution: TriNavFlex and mapping code expansion are unlocking new procedure volume and accelerating per-account utilization, supporting the company’s 50% growth target.
- Cost Structure Reset: Streamlined R&D and G&A, plus capital structure simplification, are improving the path to profitability and freeing resources for commercial investment.
- Future Watchpoint: Margin recovery and evidence-driven expansion into new indications will be key to sustaining momentum and achieving cash flow positivity in 2026.
Conclusion
Trisalis Life Sciences is at a pivotal point, leveraging device innovation and market access wins to drive top-line growth and operational improvement. With a sharpened focus on commercial execution and a streamlined cost base, the company is positioned to sustain momentum and deliver on its long-term value proposition.
Industry Read-Through
Trisalis’ results highlight the critical role of product innovation and reimbursement expansion in driving adoption of interventional devices. The swift impact of new CMS codes signals the importance of payer alignment for procedural technologies, while the shift from in-house drug development to external partnerships reflects a broader trend toward capital efficiency in life sciences. Device companies with robust clinical evidence and a disciplined commercial model are best positioned to capture share in increasingly complex therapeutic landscapes.