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

Issuer:     EDAP TMS SA (EDAP)
CIK:        0001041934
Form:       8-K
Filed at:   2026-03-18T23:59:59+00:00
Accession:  0001171843-26-001688
Event type: other_material
Sentiment:  neutral
Materiality: 0.25
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EDAP TMS highlights 87 Focal One installs, 29% procedure CAGR in Oppenheimer presentation
--------------------------------------------------------------------------------

- 87 Focal One systems installed globally (42 academic, 45 community) as of Dec. 31, 2025.
- Focal One procedures CAGR 29% and installations CAGR 52% from 2021 to 2025.
- 2026 hospital outpatient Medicare payment for HIFU remains $9,671 at APC Level 6.
- HIFI trial (3,328 patients) showed 90% STFS vs 86% RP, superior continence and erectile function.
- FARP randomized trial: 93.5% TFF at 3 years for focal ablation vs 91.5% RP, with better functional outcomes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326001688/0001171843-26-001688-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326001688/f8k_031826.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-001688

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