secwatch.observer — SEC 8-K summary
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Issuer:     EDAP TMS SA (EDAP)
CIK:        0001041934
Form:       8-K
Filed at:   2026-08-11T21:04:53+00:00
Accession:  0001104659-26-094134
Event type: earnings
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 8.01, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1041934/000110465926094134/0001104659-26-094134-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1041934/000110465926094134/tm2622525d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-094134

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