$FOCL

EDAP TMS SA (FOCL) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. EX-3.1 2 exh_31.htm EXHIBIT 3.1 Exhibit 3.1 EDAP TMS A stock company ( société anonyme ) with a capital of Euros 4,909,123.83 Head office: Parc d’activité- La Poudrette Lamartine 4 rue du Dauphiné 69120 Vaulx en Velin – France 316 488 204 R.C.S Lyon MEMORANDUM AND ARTICLES OF ASS

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FocalTherics (formerly EDAP TMS S.A., FOCL) said it has partnered with MellingMedical to expand access to its Focal One robotic HIFU system for veterans with prostate cancer. The company plans to make the technology available via MellingMedical’s VA Federal Supply Schedule across VA and DoD healthcare providers. FOCL was trading at $4.71, down 0.72%.

Edap Tms (NASDAQ:EDAP) shares rose 2.9% and crossed above its 200-day moving average, trading up to $4.47 and last at $4.32. The 200-day average was $3.59. Analysts cited include HC Wainwright cutting its target to $10 (buy) and Wall Street Zen changing to sell; MarketBeat reports consensus hold and $6 target. In May 7 results, EPS was ($0.24) vs ($0.22) expected and revenue was $20.48M vs $19.46M.

EDAP TMS S.A. said it will operate under the corporate name “FocalTherics™” and change its Nasdaq ticker from “EDAP” to “FOCL,” effective June 1, 2026 at market open. The company also plans to classify its legacy ESWL and Distribution segments as discontinued operations starting with Q2 2026 results. An investor day is scheduled for June 1, 2026.

This document provides the transcript of the EDAP TMS SA Q1 2026 Earnings Call, held on May 7, 2026. The call details the company's financial and operating results for the first quarter of 2026. Louisa Smith from Gilmartin Group hosted the initial part of the conference call.

EDAP (Nasdaq: EDAP) reported record HIFU revenue of $11.6 million in Q1 2026, marking a 78% year-over-year increase, driven by an 83% rise in Focal One system sales and 53% growth in U.S. procedures. The company also announced international capital sales in the UK, France, and Hungary, where Focal One Robotic HIFU will be used for both prostate cancer and deep infiltrating endometriosis. Despite this growth, EDAP reported a net loss of $9.1 million for the quarter, but reiterated its 2026 HIFU revenue guidance of $50.0 million to $54.0 million.

EDAP TMS SA reported strong Q1 2026 revenue growth, reaching $17.8 million, largely driven by a 78% year-over-year increase in its High-Intensity Focused Ultrasound (HIFU) business, which generated $11.6 million. Despite an improved gross margin of 45.7%, the company experienced a wider net loss of $9.1 million, or $0.24 per share, due to higher operating expenses. EDAP reiterated its 2026 financial guidance, anticipating significant growth in HIFU revenue.

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