Quarterly UpdatesAug 11, 2026, 05:10 PM
EDAP TMS Reports Preliminary Q2 2026 Results; Expands Indications
AI Summary
EDAP TMS S.A., operating as FocalTherics, announced preliminary unaudited financial results for its HIFU segment for the second quarter of 2026, showing strong revenue and gross margin growth. The company also detailed its strategic expansion into new indications for its Focal One Robotic HIFU platform, including benign prostatic hyperplasia (BPH) and deep infiltrating endometriosis. This strategic shift includes reclassifying its ESWL and Distribution segments as discontinued operations, focusing on high-growth robotic focal therapy.
Key Highlights
- Preliminary Q2 2026 HIFU segment revenue is estimated between $12.7 million and $13.2 million, an increase of 34% to 39% year-over-year.
- Preliminary Q2 2026 HIFU segment gross margin is estimated between 54% and 56%, an increase of 3% to 5% year-over-year.
- Cash, cash equivalents, and short-term investments totaled $21.5 million as of June 30, 2026.
- The company reclassified its Extracorporeal Shock Wave Lithotripsy (ESWL) and Distribution segments as discontinued operations.
- Advancing the Focal One Robotic HIFU platform for potential treatment of benign prostatic hyperplasia (BPH), with feasibility studies underway.
- Advancing the Focal One Robotic HIFU platform for deep infiltrating endometriosis, with a CE mark in Europe and FDA Breakthrough Device Designation in the U.S.
- HIFU capital sales included 13 Focal One System sales, representing 44% year-over-year growth.
- The global HIFU installed base reached 184 Focal One Systems, up from 146 in Q2 2025.
Price Impact
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