---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-003113"
form_type: "8-K"
ticker: "EDAP"
cik: "0001041934"
company_name: "EDAP TMS SA"
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T21:21:20.190778+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# EDAP Q1 2026: record HIFU revenue $11.6M (+78% YoY); net loss $9.1M

## Summary
- 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.

## SEC filing metadata
- accession: 0001171843-26-003113
- form_type: 8-K
- ticker: EDAP
- cik: 0001041934
- company_name: EDAP TMS SA
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1041934/000117184326003113/0001171843-26-003113-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1041934/000117184326003113/f8k_050726.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-003113
- JSON: https://secwatch.observer/filing/0001171843-26-003113.json
- Plain text: https://secwatch.observer/filing/0001171843-26-003113.txt

## Source-grounded claims
- claim_id: 7c8a87bb2016be47d98ebeaf0adae7b130287095
  claim: EDAP TMS SA reported the first quarter of 2026 results: revenue $17.8 million, net income $9.1 million, or ($0.24) per share, EPS ($0.24) per share. Guidance reaffirmed.
  evidence_excerpt: focus on the high-growth, high margin opportunity in focal therapy through its Focal One Robotic HIFU platform. Company Total worldwide revenue for the first quarter of 2026 was $17.8 million, compared to $14.3 million for the same period in 2025. Gross profit margin on net sales was 45.7%, up from 42.0% for the same period in 2025. The margin improvement was
  evidence_url: https://www.sec.gov/Archives/edgar/data/1041934/000117184326003113/0001171843-26-003113-index.htm

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