Every 8-K that EDAP TMS S.A. (FOCL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow FOCL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full FOCL filings page.
EDAP TMS S.A. (FOCL) reports that the underwriters in its recent equity offering have fully exercised their over-allotment option. The original underwritten public offering consisted of 8,425,000 American Depositary Shares (ADSs), each representing one ordinary share with a nominal value of €0.13, priced at $4.75 per ADS before underwriting discounts and commissions, and closed on August 14, 2026.
On August 14, 2026, the underwriters elected to purchase an additional 1,263,750 ADSs under the 30‑day option. The issuance of these additional ADSs is expected to close on August 19, 2026 and is expected to generate approximately $5.6 million in net proceeds to EDAP TMS S.A., after underwriting discounts and commissions and before estimated offering expenses. The company also filed a legal opinion from Jones Day covering the validity of the ordinary shares and these additional ADSs.
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.
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.