secwatch.observer — SEC 8-K summary
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Issuer:     EDAP TMS SA (EDAP)
CIK:        0001041934
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001171843-26-003113
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

EDAP Q1 2026: record HIFU revenue $11.6M (+78% YoY); net loss $9.1M
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- HIFU revenue $11.6M, up 78% YoY; total revenue $17.8M vs $14.3M in Q1 2025.
- Eleven Focal One systems sold (+83% YoY); U.S. HIFU procedures up 53% YoY.
- Gross margin improved to 45.7% from 42.0% on favorable HIFU mix.
- Reiterated FY 2026 HIFU revenue guidance $50-54M; non-core $22-26M.
- HIFI-2 study in European Urology Oncology supports Focal One for salvage HIFU after radiation failure.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326003113/0001171843-26-003113-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1041934/000117184326003113/f8k_050726.htm
  HTML page:      https://secwatch.observer/filing/0001171843-26-003113

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer