secwatch.observer — SEC 8-K summary
======================================

Issuer:     EDAP TMS SA (EDAP)
CIK:        0001041934
Form:       8-K
Filed at:   2026-01-12T23:59:59+00:00
Accession:  0001171843-26-000204
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EDAP reports record Q4 HIFU revenue $12.9-13.3M; issues 2026 guidance $50-54M
-----------------------------------------------------------------------------

- Q4 HIFU revenue $12.9-13.3M (record); FY2025 HIFU revenue $36.7-37.2M, up 36-38% YoY.
- 15 Focal One systems placed in Q4; FY2025 placements up 69% YoY.
- US Focal One procedures grew 28% YoY in Q4; 87 systems installed globally as of Dec 31, 2025.
- 2026 HIFU revenue guidance $50-54M; non-core revenue guided $22-26M.
- CEO highlights accelerating demand, clinical validation from HIFI and FARP trials.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326000204/0001171843-26-000204-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326000204/f8k_011226.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-000204

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer