---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-094134"
form_type: "8-K"
ticker: "EDAP"
cik: "0001041934"
company_name: "EDAP TMS SA"
filed_at: "2026-08-11T21:04:53+00:00"
generated_at: "2026-08-11T21:06:18.844481+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FocalTherics reports preliminary Q2 2026 HIFU revenue $12.7-13.2M, up 34-39% YoY; ESWL held for sale

## Summary
- Q2 2026 HIFU revenue $12.7M-$13.2M (+34-39% YoY); gross margin 54-56% (+3-5 pts); operating loss ($8.5M)-($7.5M).
- ESWL and Distribution segments classified as discontinued operations/held for sale; HIFU reported as continuing operations.
- Sold 13 Focal One systems (+44% YoY); installed base 184 (+38 vs Q2'25); U.S. procedure volume +47% YoY.
- Cash $21.5M at June 30, 2026; drew €12.0M Tranche B from EIB in April 2026.
- Expanding Focal One into BPH (IRB approved in US) and endometriosis (CE mark, FDA Breakthrough, commercial launch at Toulouse).

## SEC filing metadata
- accession: 0001104659-26-094134
- form_type: 8-K
- ticker: EDAP
- cik: 0001041934
- company_name: EDAP TMS SA
- filed_at: 2026-08-11T21:04:53+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 8.01, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1041934/000110465926094134/0001104659-26-094134-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1041934/000110465926094134/tm2622525d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-094134
- JSON: https://secwatch.observer/filing/0001104659-26-094134.json
- Plain text: https://secwatch.observer/filing/0001104659-26-094134.txt

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