---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-000204"
form_type: "8-K"
ticker: "EDAP"
cik: "0001041934"
company_name: "EDAP TMS SA"
filed_at: "2026-01-12T23:59:59+00:00"
generated_at: "2026-05-16T10:45:59.394878+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001171843-26-000204
- form_type: 8-K
- ticker: EDAP
- cik: 0001041934
- company_name: EDAP TMS SA
- filed_at: 2026-01-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1041934/000117184326000204/0001171843-26-000204-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1041934/000117184326000204/f8k_011226.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-000204
- JSON: https://secwatch.observer/filing/0001171843-26-000204.json
- Plain text: https://secwatch.observer/filing/0001171843-26-000204.txt

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