Spectral AI, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsSpectral AI is a pre-commercial medical diagnostics company that has just received FDA De Novo clearance for its AI-powered DeepView burn imaging system and is preparing for its first US sales by the end of 2026.
What they do
Spectral AI develops the DeepView System, a multi-spectral imaging device paired with proprietary AI algorithms that predict whether burn wounds will heal. The company operates in a single segment, devoting nearly all efforts to R&D and regulatory clearance. It has no product revenue to date, funded largely by US government contracts, primarily with BARDA.
Revenue drivers
- BARDA Project BioShield contract — Largest revenue source; contract valued up to $150M, with $31.7M accelerated funding exercised in March 2026 and $63.4M in additional options remaining.
- Other US government contracts — Includes NSF, NIH, DHA, and MTEC contracts; MTEC contract completed in 2026, contributing to revenue declines.
- Future commercial sales of DeepView System — Expected to begin by end of 2026 in the US (following De Novo clearance) and in the UK (UKCA mark received in 2024); SaaS and imaging device revenue streams planned.
Recent performance
In Q2 2026 (quarter ended June 30, 2026), revenue was $3.5 million, down from $5.1 million in Q2 2025, reflecting reduced BARDA reimbursements and completion of MTEC work. For the first half of 2026, revenue was $7.5 million. Net loss for 2025 was $7.6 million on revenue of $19.6 million, improving from a loss of $15.2 million in 2024. Cash and equivalents stood at $14.0 million as of June 30, 2026.
Strategy
Management is focused on commercializing the DeepView System for burn indications following FDA De Novo clearance in May 2026. They plan to launch US sales by year-end 2026, expand the UKCA label to include additional geographies, and initiate a Triage and Treatment Outcome Study in Q4 2026. They have also drawn $6.5 million under the Avenue Capital credit facility to strengthen the balance sheet and expanded leadership with a new CFO and CCO. The company is pursuing label expansion to heads, hands, and feet via a UK study.
Risks
- No commercial revenue yet — The company has generated no product revenue and depends on government contracts; achieving sales is unproven.
- Reliance on BARDA funding — BARDA is the largest single source of revenue; the contract is not guaranteed to be fully awarded or extended.
- Regulatory and commercialization hurdles — Delays in obtaining or maintaining regulatory clearances (e.g., FDA, UKCA) or reimbursement could impair commercial launch.
- Negative equity and ongoing losses — As of June 30, 2026, total liabilities exceeded assets, with shareholder equity at -$12.1 million, and the company has incurred losses since inception.
Outlook
Management expects to generate first commercial sales in the US by year-end 2026 and to complete UKCA label expansion for sales in the UK, Australia, or Gulf Cooperation Council countries by year-end 2026. They plan to initiate a triage and treatment outcome study in Q4 2026 to support clinical adoption. The BARDA contract opens the door for expanded procurement and deployment of DeepView Systems at emergency rooms and burn centers.