---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-001889"
form_type: "8-K"
ticker: "EDAP"
cik: "0001041934"
company_name: "EDAP TMS SA"
filed_at: "2026-03-25T23:59:59+00:00"
generated_at: "2026-05-15T08:57:50.683083+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# EDAP reports record 2025 HIFU revenue up 39% YoY; net loss widens, FY2026 guidance reaffirmed

## Summary
- HIFU revenue €33.1M in FY2025, +39% YoY; Focal One placements up 69% YoY.
- Q4 HIFU revenue €11.7M (+34% YoY); Q4 U.S. procedures grew 28% YoY.
- Q4 net loss €8.2M (€0.22/share) vs €1.9M (€0.05/share) prior year; operating loss €5.2M.
- Q4 gross margin 42.6%, down from 44.8%, due to tariffs and inventory reserve; adjusted ~46.9%.
- Reaffirms FY2026 revenue guidance $72-80M; core HIFU $50-54M (34-45% YoY growth).

## SEC filing metadata
- accession: 0001171843-26-001889
- form_type: 8-K
- ticker: EDAP
- cik: 0001041934
- company_name: EDAP TMS SA
- filed_at: 2026-03-25T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1041934/000117184326001889/0001171843-26-001889-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1041934/000117184326001889/f8k_032326.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-001889
- JSON: https://secwatch.observer/filing/0001171843-26-001889.json
- Plain text: https://secwatch.observer/filing/0001171843-26-001889.txt

## Key facts
- Earnings Releases
  EDAP TMS SA updated its the fourth quarter and full-year 2025 guidance (reaffirmed).
  - Period: the fourth quarter and full-year 2025
  - Guidance: reaffirmed
  - Result: reported results
  source text: On March 25, 2026, EDAP TMS S.A. issued a press release and will hold a conference call regarding its financial results for the quarter ended December 31, 2025.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1041934/000117184326001889/0001171843-26-001889-index.htm

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