EDAP TMS SA 8K

FocalTherics™ reported strong Q2 2026 HIFU revenue and procedure growth while reclassifying its ESWL and Distribution segments as discontinued operations, incurring a larger net loss driven by warrant revaluation and transition costs, and reiterating 2026 guidance alongside an announced $40 million equity offering.

On August 13, 2026, FocalTherics™ (formerly EDAP TMS S.A., Nasdaq: FOCL) reported its second quarter 2026 financial results, presenting its HIFU business as continuing operations and reclassifying its ESWL and Distribution businesses as discontinued operations following a strategic decision to exit those segments. The company delivered 39% year-over-year revenue growth to $13.2 million and 47% growth in U.S. procedures, expanded its Focal One installed base to 184 systems, and improved gross margin to 55.6%, but recorded a higher net loss of $14.4 million for the quarter, largely due to a $5.5 million non-cash loss from revaluation of a European Investment Bank warrant liability and increased operating expenses, including one-time rebranding and transition costs. Management reiterated 2026 revenue guidance of $50–$54 million for the HIFU segment, highlighted progress on the commercial launch of its endometriosis program in Europe and plans to expand into BPH, and noted an underwritten public equity offering expected to raise approximately $40 million in gross proceeds by August 14, 2026. The filing also disclosed that, in Q2 2026, the ESWL and Distribution lines met the accounting criteria to be classified as held for sale and discontinued operations under ASC 205-20 and ASC 360-10, and that prior-period financials were recast to reflect this change.

Filing Facts

CIK

1041934

Ticker

-

Form

8K

Source Type

sec

Accession

0001171843-26-005498

Alert Tier

7