- **Revenue Growth**: Q3 2025 revenue $11.6M (+57% YoY), driven by 30% new accounts and 3% sequential growth.
- **Product Expansion**: TriNav FLX adoption 35% of mix, TriNav XP shows 100% technical success in early cases.
- **Clinical Momentum**: Thyroid embolization registry demonstrates 73% size reduction, 71% thyroid function normalization.
- **Financial Health**: Adjusted EBITDA loss $5.4M (vs $7.1M prior year), $22.7M cash balance.
- **2026 Outlook**: 50%+ growth target supported by GAE trial launch and uterine artery embolization expansion.

**【CEO Summary Section】**
- Q3 2025 revenue reached $11.6 million, up 57% YoY, driven by 30% increase in unique ordering accounts and 3% sequential growth. 
- Launched TriNav FLX for low-bar liver embolization and TriNav XP for uterine artery embolization, with FLX already accounting for 35% of product mix.
- Expanded clinical pipeline with genicular artery embolization (GAE) trial for knee osteoarthritis and thyroid embolization registry showing 71% thyroid function normalization.
- Reimbursement expansion: CMS code C8004 doubles mapping procedure utilization, with 100% technical success in thyroid studies.

**【CFO Financial Commentary】**
- Gross margin 84% (vs 86% prior year), impacted by new product ramp costs.
- R&D expenses $5.2M (+24% YoY) due to nelitolimod study closeout costs.
- Sales & marketing $6.8M (+13% YoY) driven by performance-based comp.
- Adjusted EBITDA loss $5.4M (improvement from $7.1M prior year).
- Cash balance $22.7M, with debt covenant reduced to $5M.

**【Q&A Highlights】**
- 2026 growth: Management reaffirms 50%+ revenue target, citing GAE trial launch and uterine artery embolization adoption.
- Product adoption: FLX adoption rate 35% of mix, XP early feedback shows 100% technical success in 20+ cases.
- Market expansion: Thyroid embolization registry shows 73% reduction in thyroid size, 71% thyroid function normalization.
- Gross margin outlook: CFO expects stabilization in Q4 2025 as production scales.

TriSalus Life Sciences, Inc. (TLSI) Q3 2025 Earnings Call Transcript

- **Revenue Surge**: 52% YoY growth to $11.2M, fueled by TriNav FLX adoption and new clinical codes.
- **Product Breakthrough**: FLX device exceeding expectations, enabling 10-15% incremental revenue from complex vascular cases.
- **Cost Efficiency**: R&D expenses down 17% YoY, with nelitolimod winding down to $2-3M/quarter.
- **Cash Flow Confidence**: $26.5M cash post-private placement, targeting 2026 cash flow positivity.
- **Strategic Shifts**: Partnering nelitolimod development while doubling down on PEDD platform expansion.

**【CEO Summary Section】**
- **Revenue Growth**: Q2 2025 net sales of $11.2 million, up 52% YoY and 22% sequentially, driven by TriNav product adoption and new clinical applications.
- **Product Launch Success**: TriNav FLX infusion system launched in Q2, exceeding internal sales projections and addressing tortuous vascular anatomy challenges.
- **Reimbursement Expansion**: CMS issued C8004 code in April, enabling coverage for both mapping and treatment procedures, doubling reimbursable use of TriNav technology.
- **Clinical Pipeline Progress**: Nelitolimod Phase I trials completed across multiple liver tumor types; final data expected in Q3 2025, with plans to partner for development.
- **Strategic Priorities**: Expand PEDD platform adoption, simplify capital structure via $22M private placement, and invest in commercial infrastructure for 50%+ revenue growth.

**【CFO Financial Commentary】**
- **Financial Highlights**: 
  - Gross margin 84% (down 400bps YoY due to new product ramp inefficiencies).
  - R&D expenses $3.9M (down 17% YoY, with nelitolimod-related costs winding down).
  - S&M expenses $7.2M (up 20% YoY for salesforce expansion).
  - Adjusted EBITDA loss $5.3M (narrowing 19% YoY).
  - Cash balance $26.5M post-private placement, targeting cash flow positive by early 2026.
- **Capital Structure Simplification**: 99% of preferred shares exchanged at 3.3:1 ratio, reducing shares outstanding to ~50M and eliminating 2027 reset provision.

**【Q&A Key Highlights】**
- **Mapping Code Impact**: C8004 code adoption accelerating, with >8,000 physicians trained via ZHealth reimbursement consulting service.
- **Product Contribution**: TriNav LD/LV/LX devices collectively driving 10-15% revenue growth, with FLX outperforming expectations in complex cases.
- **Expense Outlook**: 
  - R&D run rate to ~$2-3M/quarter post-nelitolimod closeout.
  - G&A expenses to be reduced to ~$4M/quarter via process optimization.
  - S&M expenses maintained to support 50%+ revenue growth.
- **Nelitolimod Strategy**: Partnering discussions expected to begin Q3 2025 with liver-focused biotechs, targeting Phase II funding.
- **2025 Guidance**: Reiterate 50%+ revenue growth, with EBITDA positivity expected in early 2026.

TriSalus Life Sciences, Inc. (TLSI) Q2 2025 Earnings Call Transcript

- **Revenue surge**: Q1 2025 sales up 42% YoY to $9.2M, driven by TriNav adoption
- **New product success**: TriNav Large and Flex expand addressable market in large vessel embolization
- **Reimbursement breakthrough**: New code doubles TriNav use cases, accelerating growth
- **Partnership potential**: Nelitolimod Phase I data supports pharma collaboration for PEDD-enabled immunotherapy
- **Margin recovery**: Gross margin expected to rebound to 85-90% in Q2
- **2025 vision**: ≥50% revenue growth, scaling commercial team to 60+ reps by end-2026

**【CEO Opening Remarks】**
- Q1 2025 revenue: $9.2M (42% YoY growth, 11% sequential increase)
- Key strategic focus: expanding PEDD adoption, advancing TriNav in liver embolization, and preparing nelitolimod for partnerships
- New product launches: TriNav Large, TriGuide, and TriNav Flex
- Market leadership: 10% share of liver TACE/TARE procedures
- Clinical milestones: Phase I nelitolimod trials complete, 32 new ordering accounts added in Q1

**【CFO Financial Update】**
- Gross margin: 84% (down 1% YoY due to factory expansion)
- R&D expenses: $3.3M (44% YoY decline)
- G&A expenses: $5M (7% QoQ increase)
- Operating loss: $7.3M (38% YoY improvement)
- Cash position: $13M + $22M private placement post-Q1
- 2025 guidance: ≥50% revenue growth, EBITDA negative but cash flow positive by Q1 2026

**【Q&A Highlights】**
1. **TriNav Large adoption**: Used in 3-5mm vessels for large tumors, early feedback positive
2. **Reimbursement expansion**: New HCPCS code doubles TriNav use cases, driving broader adoption
3. **Nelitolimod partnership strategy**: Seeking pharma partners for PEDD-enabled delivery of immunotherapy
4. **Salesforce expansion**: Adding 15+ reps over 18 months to target 400+ high-volume hospitals
5. **Gross margin outlook**: 85-90% by Q2 as factory utilization normalizes
6. **Clinical data momentum**: HEOR study shows 30% cost savings vs. standard care

TriSalus Life Sciences (TLSI)-15 May 25-2025 Q1 Earnings call transcript

- **Revenue Surge**: Q4 2024 revenue up 44% YoY to $8.3M, full-year $29.4M (59% YoY), driven by TriNav adoption in liver embolization (9% market share).
- **Pipeline Expansion**: Launched TriNav Large and TriGuide, targeting complex embolization. New CMS code C8004 unlocks $400M Medicare market for thyroid embolization.
- **Clinical Impact**: HEOR studies show 30% lower post-procedure fatigue and 20% fewer complications. PROTECT registry enrolling 100 thyroid patients across 10 sites.
- **2025 Growth**: >50% revenue growth guided, with EBITDA breakeven by mid-2025. Key catalysts: TriNav 2.0 launch, nelitolimod Phase I data, and $35M OrbiMed funding.
- **Risks**: 10-K filing delay due to auditing; 33% YoY reduction in operating losses to $36.2M.


**【CEO Strategic Overview】**
- **Revenue Growth**: Q4 2024 revenue reached $8.3M (44% YoY), full-year $29.4M (59% YoY), driven by TriNav adoption in liver embolization procedures. Market share expanded to 9% of TACE/TARE procedures.
- **Pipeline Expansion**: Introduced TriNav Large Vessel system, capturing 25% of new accounts in Q4. Launched TriGuide guiding catheter and TriNav LD infusion system, targeting complex embolization cases.
- **Clinical Evidence**: Published HEOR studies showing 30% lower post-procedure fatigue and 20% fewer complications in PEDD-treated patients. New CMS code C8004 for mapping procedures effective April 2025, enabling full reimbursement for Medicare patients.
- **2025 Outlook**: Guided for >50% revenue growth, EBITDA positivity by mid-2025, and cash flow breakeven by year-end. Key drivers include TriNav 2.0 launch, PROTECT registry enrollment (100 patients for thyroid embolization), and nelitolimod Phase I data readout.

**【CFO Financial Highlights】**
- **Revenue Performance**: Q4 gross margin 85%, full-year 86% (vs. 90% in 2023 Q4). R&D expenses down 62% YoY to $3M, G&A down 22% to $4.7M. Sales & marketing up 52% YoY to $25.8M.
- **Liquidity**: $8.5M cash at year-end, with $35M drawn from $50M OrbiMed facility. Sufficient runway for 2025 growth initiatives.
- **2025 Financial Targets**: Full-year EBITDA positive, cash flow breakeven in H2. Operating losses reduced 33% YoY to $36.2M.

**【Q&A Key Takeaways】**
- **TriNav Large Uptake**: 70% of Q4 new accounts using TriNav Large for TARE, with 10% sequential increase in utilization. CMS code C8004 expected to add 25% addressable market.
- **Nelitolimod Progress**: Phase I data in pancreatic cancer expected mid-2025. Early interest from pharma partners for UMLM indication, leveraging TriNav's venous delivery technology.
- **Account Strategy**: Shifted focus from new account openings (103 in 2024) to driving utilization (13.5 units/ordering account, +10% YoY). Q1 2025 growth expected to be back-end loaded due to adoption lag.
- **10-K Delay**: Auditing stock-based comp and R&D timing; no material impact anticipated. Finalized data to be disclosed upon filing.


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