Recent 8-K filings for EDAP

• June 1, 2026, 4:05 PM ET other material materiality 0.60 neutral item 7.01item 9.01

  EDAP TMS holds FocalTherics Investor Day; plans to exit ESWL and distribution segments to focus on HIFU

  Presentation at June 1, 2026 Investor Day highlights strategic shift to High Intensity Focused Ultrasound (HIFU) devices.

• May 29, 2026, 7:30 AM ET other material materiality 0.60 neutral item 8.01

  EDAP TMS rebrands as FocalTherics, ticker to FOCL June 1; ESWL/Distribution discontinued ops

  Corporate name changes to FocalTherics; ticker symbol switches from EDAP to FOCL effective June 1, 2026.

• May 7, 2026, 7:59 PM ET earnings materiality 0.70 positive item 2.02item 9.01 ◈ Earnings Releases

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

  HIFU revenue $11.6M, up 78% YoY; total revenue $17.8M vs $14.3M in Q1 2025.

• April 2, 2026, 7:59 PM ET debt materiality 0.65 neutral item 2.03item 3.02 ◈ Debt Financings

  EDAP TMS draws €12M second tranche from EIB credit facility; issues warrants at €3.23 strike

  Drawdown of €12.0 million under Tranche B of EIB credit facility, expected disbursement late April 2026.

• March 25, 2026, 7:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01 ◈ Earnings Releases

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

  HIFU revenue €33.1M in FY2025, +39% YoY; Focal One placements up 69% YoY.

• January 12, 2026, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 7.01item 9.01

  EDAP reports record Q4 HIFU revenue $12.9-13.3M; issues 2026 guidance $50-54M

  Q4 HIFU revenue $12.9-13.3M (record); FY2025 HIFU revenue $36.7-37.2M, up 36-38% YoY.

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.75 · Median 0.60 · Most common event other_material

2 positive 0 negative 7 neutral

source · EDAP on sec.gov