EDAP TMS SA (FOCL) Form 8-K — Aug 11, 2026
EDAP TMS, rebranded as FocalTherics (Nasdaq: FOCL), announced preliminary unaudited Q2 2026 results for its HIFU segment, with revenue of $12.7-$13.2 million, up 34-39% year over year, gross margin of 54-56%, and 13 Focal One system sales (+44% YoY). U.S. procedure volume grew 47% and the global installed base reached 184 systems. The ESWL and Distribution segments met held-for-sale criteria and will be reported as discontinued operations beginning Q2 2026, a strategic shift the company says will significantly affect operations as it refocuses entirely on robotic focal therapy under the FocalTherics brand.
Key figures
- Revenue
- $12.7-$13.2 million (Q2 2026 HIFU segment, preliminary unaudited)
- Revenue Yoy
- +34% to +39%
- Cash Position
- $21.5 million (cash, cash equivalents and short-term investments as of June 30, 2026)
- Gross Margin
- 54%-56% (+3 to +5 pts YoY)
- Operating Loss
- $7.5M-$8.5M (preliminary)
- Sales Pipeline
- 300+ hospitals
- Eib Tranche BDraw
- €12.0M drawn April 2026 from EIB credit facility
- Full Results Date
- August 13, 2026 after market close, conference call 4:30 pm ET
- Hifu System Sales
- 13
- Us Installed Systems
- 96
- Global Installed Base
- 184
- System Sales Growth Yoy
- +44%
- Installed Base Prior Year
- 146
- Management Estimated Tam
- $10B+ revenue / 4.3M+ procedures across prostate cancer, BPH, and endometriosis
- Us Procedure Volume Growth
- +47% YoY
- Physician Payment2026 Hifu
- $884
- Proposed2027 Opps Hifu Payment
- $10,797
- Proposed2027 Opps Payment Increase
- +11.6%
Price after filing
Close on the filing date to close N calendar days later (from $6.01). Historical, not a forecast.
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