{"url_path":"/sec/focl/8-k/2026-08-11/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 ****Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-08-11","source_url":"https://www.sec.gov/Archives/edgar/data/1041934/0001104659-26-094134-index.html","accession_number":"0001104659-26-094134","cik":"0001041934","ticker":"FOCL","issuer_name":"EDAP TMS SA","edgar_url":"https://www.sec.gov/Archives/edgar/data/1041934/0001104659-26-094134-index.html","primary_entity_key":"0001041934","primary_entity_name":"EDAP TMS SA"},"word_count":809,"has_tables":true,"body_markdown":"**Item 8.01****Other Events.**\n\n \n\nOn August 11, 2026, the Company made a\npresentation (the “Investor Presentation”) available on the “Investors” section of its website at\nwww.focalone.com. The Investor Presentation is filed as Exhibit 99.2 hereto and is incorporated herein by reference.\n\n \n\n**Expansion into New Indications**\n\n \n\n*Expansion into Benign Prostatic Hyperplasia (BPH)*\n\n \n\nThe Company is advancing the evaluation of its\nFocal One Robotic HIFU platform for the potential treatment of benign prostatic hyperplasia (\"BPH\"). Based on published third-party\nestimates, more than 100 million men worldwide are living with BPH, with more than 13 million new cases diagnosed annually including\nover 600,000 in the United States. The Company believes its experience in robotic HIFU for prostate cancer may provide a foundation for\ndeveloping a non-invasive treatment option for patients with BPH. The Company’s BPH development program is currently focused on\nfeasibility studies inside and outside the United States. In the United States, the feasibility study has received Institutional Review\nBoard approval. Outside the United States, a multicenter feasibility study is underway.\n\n \n\nFocal One has not been cleared or approved by\nthe U.S. Food and Drug Administration (the \"FDA\") or any other regulatory authority for the treatment of BPH, and its use for\nthat indication is investigational. There can be no assurance that the Company’s BPH development program will be successful or\nthat Focal One will receive regulatory clearance or approval for this indication.\n\n \n\n*Expansion into Endometriosis*\n\n \n\nThe Company is also advancing development of the\nFocal One Robotic HIFU platform for the potential treatment of deep infiltrating endometriosis, a severe form of endometriosis for which\ntreatment options are currently limited primarily to hormonal therapy and surgery. Based on published third-party estimates, approximately\n38 million women worldwide are affected by deep infiltrating endometriosis, with more than 783,000 patients diagnosed annually including\nover 225,000 in the United States. The Company believes its robotic HIFU technology may provide a non-invasive treatment alternative,\nas opposed to current treatment options that are limited to hormone therapy and/or invasive surgery, designed to reduce symptoms and\nimprove quality of life. Outside the United States, the Company’s endometriosis program is progressing through ongoing clinical\ndevelopment, including a randomized controlled pivotal study, and the Company has initiated a limited commercial launch in Europe under\nits CE mark for this indication. In the United States, the Company received FDA Breakthrough Device Designation for this indication in\n2024 and is evaluating long-term data generated from its European studies to inform its regulatory strategy.\n\n \n\nFocal One has not been cleared or approved by\nthe FDA for the treatment of deep infiltrating endometriosis, and its use for that indication in the United States is investigational.\nBreakthrough Device Designation provides for enhanced interaction with the FDA during development and review but does not guarantee or\naccelerate clearance or approval, and there can be no assurance that Focal One will receive clearance or approval for this indication.\n\n \n\n \n\n \n\n \n\n**Cautionary Statement on Forward-Looking Statements**\n\n \n\nIn addition to historical information, this\nCurrent Report on Form 8-K contains forward-looking statements within the meaning of applicable federal securities laws,\nincluding Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S.\nSecurities Exchange Act of 1934, as amended, including the information contained in the Press Release, the information contained in\nthe Investor Presentation and the information concerning the new indications, which may be identified by words such as\n“believe,” “can,” “contemplate,” “could,” “plan,” “intend,”\n“is designed to,” “may,” “might,” “potential,” “objective,”\n“target,” “project,” “predict,” “forecast,” “ambition,”\n“guideline,” “should,” “will,” “estimate,” “expect” and\n“anticipate,” or the negative of these and similar expressions, which reflect the Company’s views about future\nevents and financial performance. Such statements are based on management's current expectations and are subject to a number of\nrisks and uncertainties, including matters not yet known to the Company or not currently considered material by the Company, and\nthere can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important\nfactors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include,\nbut are not limited to, uncertainties related to market conditions and those risks relating to the Company’s business, which are described in the Company’s\nfilings with the SEC and in particular in the section “Risk Factors” in the Company's Annual Report on Form 10-K\nand Quarterly Report on Form 10-Q.\n\n \n\nForward-looking statements speak only as of the\ndate they are made. Other than required by law, the Company does not undertake any obligation to update them in light of new information\nor future developments. These forward-looking statements are based upon information, assumptions and estimates available to the Company\nas of the date of this Current Report on Form 8-K, and while the Company believes such information forms a reasonable basis for\nsuch statements, such information may be limited or incomplete."}