EDAP TMS S.A. (FOCL), now focused on its Focal One HIFU robotic focal therapy business, reported strong top-line growth but widening losses for the quarter and six months ended June 30, 2026. Continuing-operations revenues rose to $13.2 million for the quarter and $24.8 million year‑to‑date, driven by higher Focal One unit sales and treatment‑driven revenue.
Gross margin improved to 55.6% for the quarter and 53.6% for the six months, reflecting lower standard costs and better absorption of fixed costs. Operating expenses increased sharply as the company expanded U.S. commercialization and absorbed higher G&A from its transition to U.S. domestic filer status, leading to operating losses of $8.0 million for the quarter and $16.1 million year‑to‑date.
Net loss from all operations widened to $14.5 million for the quarter and $23.6 million for the six months, heavily impacted by $7.9 million of non‑cash financial expense tied to European Investment Bank warrant fair‑value changes and loan amortization. Shareholders’ equity swung from $19.4 million at year‑end 2025 to a deficit of $3.2 million, while cash reached $21.5 million, before an additional $37.1 million of net proceeds from an August 2026 ADS offering. The company classified its ESWL and Distribution segments as discontinued operations and plans to dispose of them within one year to concentrate exclusively on HIFU.
EDAP TMS S.A. entered into an Underwriting Agreement with TD Securities (USA) LLC and Mizuho Securities USA LLC for an underwritten public offering of 8,425,000 American Depositary Shares (ADSs), each representing one ordinary share, at $4.75 per ADS, before underwriting discounts and commissions. The transaction, made under an effective Form S-3 shelf registration and an August 11, 2026 prospectus supplement, is expected to close on August 14, 2026. The company granted the underwriters a 30-day option to purchase up to an additional 1,263,750 ADSs. Net proceeds are expected to be approximately $37.1 million, to be used for operating costs, capital expenditures and general corporate purposes, including working capital. Executive officers and directors agreed to a 90-day lock-up on ADSs, ordinary shares and related securities, subject to limited exceptions and potential waiver by the representatives.
FocalTherics (formerly EDAP TMS) reported second-quarter 2026 results for its continuing HIFU business, with total revenue of $13.2 million, up 39% from $9.5 million a year earlier. The company sold 13 Focal One systems versus 9 in 2025 and U.S. Focal One procedures grew 47% year-over-year.
Gross margin improved to 55.6% from 51.1%, driven by better standard costs and higher production volumes. Operating expenses rose to $15.4 million, including about $0.8 million of one-time rebranding, filer-transition, and discontinued-operations costs. Operating loss widened to $8.0 million, and net loss from continuing operations increased to $14.4 million, or ($0.39) per share, largely due to a $5.5 million loss from change in fair value of a warrant liability.
For the first half of 2026, continuing-operations revenue was $24.8 million with gross profit of $13.3 million. As of June 30, 2026, cash and cash equivalents were $21.5 million, long-term debt was $37.2 million, and shareholders’ equity was negative $3.2 million. The company reclassified its ESWL and Distribution segments as discontinued operations and reiterated 2026 guidance for its HIFU segment.
EDAP TMS S.A. (FocalTherics) is conducting a primary offering of 8,425,000 American Depositary Shares (ADSs), each representing one ordinary share, at $4.75 per ADS, for a gross offering size of $40.0 million. Underwriters have a 30‑day option to purchase up to 1,263,750 additional ADSs. Estimated net proceeds are about $37.1 million, to be used for operating costs, capital expenditures and general corporate purposes, including working capital.
The company develops and sells the Focal One Robotic HIFU system for minimally invasive treatment of prostate cancer and other indications. It plans to discontinue its ESWL and Distribution segments, which will be reported as discontinued operations from 2Q 2026. Preliminary unaudited results for the six months ended June 30, 2026 indicate revenue from continuing operations of $24.3–$24.8 million and a net loss from continuing operations of $(24.3)–$(24.0) million, with cash, cash equivalents and short-term investments of $21.5 million.
EDAP TMS S.A., operating as FocalTherics, is conducting a primary offering of American Depositary Shares (ADSs), each representing one ordinary share, under an effective Form S-3 shelf registration. The ADSs trade on the Nasdaq Global Market under the symbol FOCL, following a June 1, 2026 ticker change from EDAP.
The company focuses on minimally invasive therapeutic ultrasound, led by its Focal One Robotic HIFU system for prostate cancer and investigational use in benign prostatic hyperplasia and deep infiltrating endometriosis, including an FDA Breakthrough Device Designation for the latter. It plans to discontinue its ESWL and Distribution segments, which will be reported as discontinued operations.
Preliminary unaudited results for the six months ended June 30, 2026 show revenue from continuing operations between $24.3 million and $24.8 million versus $16.0 million a year earlier, with a net loss from continuing operations between $24.3 million and $24.0 million. Cash, cash equivalents and short-term investments were $21.5 million as of June 30, 2026. If this offering is not completed, the company expects to disclose substantial doubt about its ability to continue as a going concern and would need additional funding.
FocalTherics (FOCL) reported preliminary, unaudited second-quarter 2026 figures focused on its HIFU segment, now presented as continuing operations. The ESWL and Distribution segments met criteria to be classified as held for sale and are reported as discontinued operations, reflecting a strategic shift expected to significantly affect operations and financial results. Cash, cash equivalents and short-term investments from all operations totaled $21.5 million as of June 30, 2026.
The company is advancing its Focal One Robotic HIFU platform into new indications. Feasibility studies for benign prostatic hyperplasia are underway in and outside the United States. For deep infiltrating endometriosis, development includes a randomized controlled pivotal study, a limited commercial launch in Europe under a CE mark, and an FDA Breakthrough Device Designation in the United States, where the indication remains investigational.
EDAP TMS S.A. held its 2026 Annual General Meeting on June 26, 2026, where shareholders approved multiple governance and capital-related resolutions. A total of 37,484,065 Ordinary Shares, including those represented by American Depositary Shares, were represented and voted.
Shareholders renewed the terms of all nominated directors, ratified the temporary appointment of David Horn, approved related-person agreements, and validated the 2025 statutory and consolidated financial statements and result allocation. They also renewed the statutory auditor and backed executive compensation and annual say‑on‑pay votes.
Extensive delegations were granted to the Board to increase share capital through various issuances, including with or without preferential subscription rights, and in connection with mergers or asset contributions, as well as to grant free shares. Bylaw amendments affecting share capital, the Board of Directors, and shareholders’ meetings were approved, while a capital increase for employees in a company savings plan was not approved.