- **Cash Position Solid**: $10.5 million cash on hand, bolstered by $7.6 million funding, supporting 2025-2026 operations.
- **FDA Approval On Track**: Despite government shutdown delays, FDA interactions remain productive, targeting H1 2026 clearance.
- **Revenue Adjustment**: 2025 revenue guidance reduced to $18.5 million, with 2026 expected to mirror 2025 levels.
- **Commercial Momentum**: Hiring 4 FTEs for U.S. launch, leveraging international success (U.K., Australia) to drive adoption.
- **Innovation Pipeline**: Handheld device development funded by military, with potential civilian applications post-launch.

**【Management Opening Remarks】**
- **Financial Stability**: Cash balance remained at $10.5 million, with an additional $7.6 million from a registered direct offering, providing sufficient capital for 2025-2026 operations.
- **FDA Progress**: Submitted FDA de novo application in June 2025, facing delays due to the U.S. government shutdown but maintaining focus on first-half 2026 approval.
- **Commercialization Readiness**: Planning U.S. launch of DeepView system, with international units in the U.K. and Australia receiving positive feedback, including ease of use and clinical benefits.

**【CFO Financial Commentary】**
- **Revenue Decline**: R&D revenue dropped to $3.8 million (Q3 2025) from $8.2 million (Q3 2024) due to reduced BARDA contract activity post-FDA submission.
- **Profitability Challenges**: Net loss widened to $3.6 million (Q3 2025) from $1.5 million (Q3 2024), driven by higher G&A expenses and lower reimbursements.
- **Guidance Update**: Reduced 2025 revenue guidance to $18.5 million (from $21.5 million), anticipating partial recovery in 2026 post-government shutdown resolution.

**【Q&A Highlights】**
- **FDA Interactions**: Despite delays, ongoing productive dialogue with FDA; statistical analysis plan (SAP) for AI algorithm received favorable feedback.
- **Handheld Device Development**: Military-funded handheld module in testing phase, with potential civilian application post-FDA clearance.
- **Commercialization Strategy**: Hiring 4 FTEs for 2026 to support sales and education, leveraging BARDA funding for burn center placements.
- **International Expansion**: Positive feedback from U.K. units; planning CE Mark and UKCA clearance for European market entry.
- **IP Transaction**: Spectral IP acquisition expected to close in Q1 2026, enhancing intellectual property portfolio.

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