Spectral AI Inc
NASDAQ:MDAI
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Spectral AI Inc
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Spectral AI Inc
Spectral AI Inc is a US-based company operating in industry. The company is headquartered in Dallas, Texas. The company went IPO on 2021-02-12. Rosecliff Acquisition Corp I is a blank check company. The firm is formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination. The firm has not selected any specific business combination target. The firm intends to focus its search on identifying high growth technology and tech-enabled businesses.
Spectral AI Inc is a US-based company operating in industry. The company is headquartered in Dallas, Texas. The company went IPO on 2021-02-12. Rosecliff Acquisition Corp I is a blank check company. The firm is formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination. The firm has not selected any specific business combination target. The firm intends to focus its search on identifying high growth technology and tech-enabled businesses.
FDA timing: Company submitted a de novo to the FDA in June 2025, responded to an additional information request earlier this month, and is hopeful for a positive decision before the end of Q2 2026.
BARDA funding: BARDA advanced $31.7 million to accelerate Phase 2 work (part of a contract worth up to $150 million, $55 million previously awarded) and Spectral committed an additional $9.7 million to development costs.
Commercial readiness: Management is preparing to commercialize in late 2026 if cleared — hiring a Chief Commercial Officer, engaging Deloitte for commercialization planning, expanding sales and BME/training staff.
Clinical validation: A 15-month burn validation study (164 patients across 15 U.S. sites) showed DeepView outperformed clinician judgment; an outcome study is planned post-clearance.
Financials / liquidity: Cash at year-end was $15.4 million (up from $5.2 million at 12/31/24), total debt $8.5 million, and the company forecasts 2026 revenue of approximately $18.5 million (not including device sales).
International and product roadmap: UKCA authorization exists for 2024 burn indication; company will update UKCA after a positive FDA decision and plans initial international sales in late 2026. A handheld prototype under DoD/MTEC Phase II is due by end of Q2 2026.
