---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-001688"
form_type: "8-K"
ticker: "EDAP"
cik: "0001041934"
company_name: "EDAP TMS SA"
filed_at: "2026-03-18T23:59:59+00:00"
generated_at: "2026-05-15T09:49:00.278407+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.25
calibrated_materiality_score: 0.25
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001171843-26-001688
- form_type: 8-K
- ticker: EDAP
- cik: 0001041934
- company_name: EDAP TMS SA
- filed_at: 2026-03-18T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.25
- calibrated_materiality_score: 0.25
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1041934/000117184326001688/0001171843-26-001688-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1041934/000117184326001688/f8k_031826.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-001688
- JSON: https://secwatch.observer/filing/0001171843-26-001688.json
- Plain text: https://secwatch.observer/filing/0001171843-26-001688.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.