FocalTherics reports preliminary Q2 2026 HIFU revenue $12.7-13.2M, up 34-39% YoY; ESWL held for sale

EDAP TMS SA

Q2 2026 HIFU revenue $12.7M-$13.2M (+34-39% YoY); gross margin 54-56% (+3-5 pts); operating loss ($8.5M)-($7.5M).
ESWL and Distribution segments classified as discontinued operations/held for sale; HIFU reported as continuing operations.
Sold 13 Focal One systems (+44% YoY); installed base 184 (+38 vs Q2'25); U.S. procedure volume +47% YoY.
Cash $21.5M at June 30, 2026; drew €12.0M Tranche B from EIB in April 2026.
Expanding Focal One into BPH (IRB approved in US) and endometriosis (CE mark, FDA Breakthrough, commercial launch at Toulouse).

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