- **Financial Strength**: $13.3M cash, $1M/month burn, no debt – 12+ months of runway.
- **FDA-Cleared Robot**: First U.S. surgeries Q3 2025, India trial starts Q2 2025.
- **Key Differentiator**: Autonomous cutting reduces surgeon fatigue, costs $1.2M less per case vs. Mako.
- **Growth Catalyst**: 70% of new surgeons trained on robots; Monogram targets 9% market share by 2031.
- **Next-Gen Hardware**: Upgraded system tested in Q1, FDA-cleared robots upgradable to new version.
- **Capital Plan**: Seeking funding to scale post-demonstration of clinical success.

**【CFO Financial Summary】**
- **Cash Position**: $13.3 million as of Q1 2025, with monthly cash burn reduced to $0.8 million (down from $1.1-$1.2 million in 2024).
- **Burn Rate**: Projected $1 million/month for 2025, providing over 12 months of runway.
- **Clinical Trial Spend**: $1.2 million expected over 6-9 months for India trial.
- **Balance Sheet**: No debt, minimal warrant obligations, strong financial flexibility.

**【CEO Business Update】**
- **FDA Clearance**: mBôs TKA system received 510(k) approval in March 2025, enabling U.S. pilot placements.
- **Clinical Milestones**: 
  - India trial to begin within 90 days (robot en route), targeting first surgeries Q2 2025.
  - U.S. pilot placement with 4 surgeons expected Q3 2025.
- **Competitive Differentiators**: 
  - Autonomous saw-based cutting vs. Stryker's Mako (manual blade changes, higher cost).
  - AI-driven landmark placement for accuracy vs. manual operator dependency.
  - Streamlined pre-op pipeline and faster bone cutting (competitive with manual surgery).
- **Market Opportunity**: 
  - 70% Mako market share among fellowship-trained surgeons, driven by early exposure.
  - 9% potential Stryker market share growth by 2031 due to retiring surgeons.
- **System Enhancements**: 
  - Upgraded end effector, blade, and software tested in Q1 2025.
  - FDA-cleared system upgradable to next-gen hardware.

**【Q&A Highlights】**
- **India Trial Timing**: First surgeries expected late Q2/Q3 2025.
- **U.S. Launch Strategy**: Slow rollout with high surgeon support to ensure >90% utilization.
- **Capital Needs**: Exploring additional funding to accelerate growth post-pilot data.
- **Competitor Comparison**: Monogram aims to match Mako's workflow while reducing surgeon fatigue and cost.

Monogram Technologies Inc. (MGRM) Q1 2025 Earnings Call Transcript

- **Cash Strong**: $15.7M ending balance with $1.2M/month burn, well-positioned for 2025 milestones.
- **Tech Leap**: Autonomous cutting system achieves 2:47 blade-to-bone time, 300% faster than prior gen.
- **Regulatory Momentum**: FDA submission active; India trial on track for ~2 months post-approval first surgery.
- **Market Play**: Targeting 50% robotic knee share by 2030; India launch precedes U.S. commercialization.

**【CFO Financial Commentary】**
- **Cash Position**: Ended Q4 with $15.7 million, up from prior year, driven by $13 million preferred D raise and cost control.
- **Cash Burn**: Maintained at $1.2 million/month, with plans to keep steady through 2025.
- **Liquidity**: Strong balance sheet with no debt, supported by ATM facility access.
- **Cost Structure**: 27 FTEs + outsourced engineering, scaled back in Q4 as VNB project wound down.

**【CEO Business Update】**
- **Robotics Thesis**: Autonomous cutting system aims to match Mako's 88% market share in robotic knees.
- **Technical Breakthrough**: New end effector achieves 2:47 blade-to-bone time, 300% faster than prior gen.
- **Regulatory Progress**: 
  - FDA submission with IQVIA support; clock restarted Feb 26 after 73-day pause.
  - India clinical trial: 102-patient study with Shalby Hospitals; first surgery ~2 months post-approval.
  - CAD testing: RMSE <1.1mm, alignment <1°, nearing clinical-grade accuracy.
- **Market Outlook**: 50% robotic knee penetration by 2030; focus on India launch before U.S. commercialization.

**【Q&A Key Points】**
- **Clinical Trial Timeline**: India trial enrollment ~3-6 months post-approval; 2-2.5 months from clearance to first surgery.
- **FDA Strategy**: Gen 1 system upgradeable to new end effector; seeking 510(k) clearance for autonomous features.
- **Cash Needs**: $1.2M annualized for India trial; Q2 may see higher testing spend but ~$1.1M/month burn maintained.
- **Capital Requirements**: Future sales/marketing expansion will require additional funding beyond current $15.7M balance.

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