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- **FDA Approval Near**: Final PMA review phase with no requested data; inspections passed without issues.
- **Restructured for Growth**: Q3 2025 revenue $2.7M (-50% YoY) reflects strategic pivot; operating expenses down 29%.
- **Debt-Free Positioning**: $5M private placement strengthens balance sheet ahead of U.S. launch.
- **Innovative Platform**: Drug-eluting balloon and 12-month capsule in development to address adherence in chronic diseases.

**【CEO Summary Section】**
- **FDA Milestones**: Submitted final PMA module in June 2025; passed pre-approval and BIMO inspections with no findings. Day-100 meeting confirmed no additional clinical data needed, signaling final review phase.
- **Q3 2025 Financials**: Revenue $2.7M (down 50% YoY) due to strategic restructuring. Operating expenses decreased 29% to $10.9M, with adjusted loss narrowing 39% to $6.9M. Restructured balance sheet to achieve debt-free status via debt-for-equity exchange and $5M private placement.
- **Strategic Shift**: Focused on accounts offering combination therapy (Smart Capsule + low-dose GLP-1s). 50%+ GLP-1 discontinuation rate in clinics creates patient pipeline. New distributors onboarded in Q4 for 2026 growth.
- **R&D Innovations**: Collaborating on drug-eluting balloon for controlled GLP-1 delivery, addressing adherence challenges. Exploring longer-lasting capsule platform for multi-therapeutic delivery.

**【CFO Financial Commentary】**
- **Revenue & Gross Profit**: $2.7M (49% gross margin) vs. $5.4M (58% margin) YoY. Lower production volumes reduced overhead absorption.
- **Expense Reductions**: 
  - Sales & Marketing: $3.1M (-40% YoY)
  - R&D: $2.0M (-38% YoY)
  - G&A: $5.8M (-14% YoY)
- **Liquidity**: $6.1M cash + $5M private placement as of Q3 end.

**【Q&A Highlights】**
- **U.S. Market Strategy**: Leverage international success in combination therapy to target U.S. clinics with high GLP-1 churn. Expected sequential Q4 growth and 2026 expansion.
- **Drug Delivery Platform**: Long-term vision for 12-month capsule delivering therapeutics/ microbiome enhancers. Potential to address adherence in chronic diseases beyond obesity.
- **Revenue Outlook**: Q4 2025 sequential growth; 2026 driven by GLP-1 price drops and new agent launches increasing discontinuation rates.

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