Spectral AI files FDA De Novo, secures $23M in debt & equity, but revenue drops 34% as BARDA base phase winds down

Filed March 25, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 31, 2025 · ~2 min read

Key Changes

• high

  Company submitted De Novo application to FDA in June 2025 for burn indication market authorization, a critical regulatory milestone toward U.S. commercialization. Validation study showed superiority in sensitivity vs. clinician assessment.

  Business: De Novo submission timing verify on EDGAR →
• high

  Revenue fell 34% to $19.7M in 2025 from $29.6M in 2024 as BARDA base phase neared completion. Post-period, BARDA advanced $31.7M from future phases but company must co-fund $9.7M of development costs, increasing financial responsibility.

  MD&A: BARDA revenue & contract modification verify on EDGAR →
• high

  Raised $23M via new Avenue debt facility ($8.5M drawn, up to $15M available) and Hudson Bay equity round ($7.6M at $1.90/share with 4.9M warrant overhang). Cash improved to $15.4M but debt increased to $8.4M and dilution risk rose.

  MD&A: Avenue & Hudson Bay financings verify on EDGAR →