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confidence medium
sentiment positive
materiality 0.70
Spectral AI updates on regulatory progress; expects UK DeepView revenue in H2 2024
Spectral AI, Inc.
- Submitted DeepView AI-Burn for UKCA marking; response expected 1H 2024; first UK revenue in H2 2024.
- BARDA awarded $149M contract in Sept 2023, total BARDA awards over $250M; $55M for development through Q1 2026.
- Initiated pivotal US burn study with 240 subjects; FDA submission for burn indication expected 1H 2025.
- DFU validation study continues; FDA application for DFU indication anticipated in late 2024.
- Closed $10M Committed Equity Facility with B. Riley; appointed Pete Carlson as CFO.