Every 8-K that EDAP TMS SA (EDAP) 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 EDAP 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 EDAP filings page.
EDAP TMS, operating as FocalTherics, used its 2026 Investor Day to lay out a pure‑play HIFU strategy and updated financial framework. The company is moving its ESWL and Distribution businesses to discontinued operations from Q2 2026 and focusing on its Focal One robotic focal therapy platform.
HIFU revenue grew from $16M in 2022 to $37M in 2025, and guidance for calendar 2026 is $50–$54M, implying about 40% year‑over‑year growth and a 32% three‑year CAGR. Management targets HIFU gross margin of roughly 60% and a pathway to breakeven operating income and positive EBITDA in 2028, driven by installed‑base expansion and procedure growth.
The presentation highlights accelerating adoption of Focal One in prostate cancer, with 91 systems in the U.S. and 41 in Europe, reimbursement support including a Cat. 1 CPT code and 2026 Medicare outpatient payment of $9,671 for HIFU, and indication expansion opportunities in benign prostatic hyperplasia and deep infiltrating endometriosis that together contribute to a stated total addressable opportunity of more than four million annual procedures and over $10B in potential revenue.
EDAP TMS S.A. announced it will begin operating under the new corporate name FocalTherics to highlight its exclusive focus on high-growth robotic focal therapy. Its American Depositary Shares will start trading on the Nasdaq Global Market under the new ticker symbol FOCL at the market open on June 1, 2026, while the legal name remains EDAP TMS S.A. and a formal legal name change will be submitted for shareholder approval at a future general meeting.
The company also plans to report and classify its Extracorporeal Shock Wave Lithotripsy and Distribution operating segments as discontinued operations beginning with its second quarter 2026 financial results. Management will discuss the new corporate identity, growth strategy, and business outlook at an Investor Day on June 1, 2026, with a live webcast and replay available through its investor relations website.
EDAP TMS reported strong growth in its High-Intensity Focused Ultrasound (HIFU) business for the first quarter of 2026 while remaining loss-making. Total revenue reached $17.8 million, up from $14.3 million a year earlier, driven by HIFU revenue of $11.6 million, a 78% year-over-year increase.
The company sold eleven Focal One systems versus six a year ago and saw worldwide disposables revenue grow 54%, helped by 53% growth in U.S. Focal One procedures. Gross margin improved to 45.7%, but higher operating expenses led to a larger net loss of $9.1 million, or ($0.24) per share. EDAP reiterated 2026 guidance, targeting $50–$54 million in HIFU revenue and $22–$26 million from non-core ESWL and distribution.
EDAP TMS has drawn €12.0 million under the second tranche of its term loan facility with the European Investment Bank. This Tranche B borrowing is expected to be disbursed in late April 2026, will mature five years after disbursement, and interest will be paid at maturity.
The credit facility allows aggregate financing of up to €36.0 million. In connection with Tranche B, EDAP issued 1,116,244 Tranche B warrants to the EIB, each allowing the purchase of one ordinary share at a strike price of €3.23. These securities were issued in a private offering relying on Section 4(a)(2) of the Securities Act.
EDAP TMS reported mixed fourth quarter and full-year 2025 results, highlighting rapid HIFU growth but wider losses. In Q4 2025, HIFU revenue rose to €11.7 million, up 34% year-over-year, with fourteen Focal One systems sold and 28% growth in U.S. procedures.
Non-core ESWL and distribution revenue fell to €7.2 million, pulling total Q4 revenue down 7% to €18.9 million. Q4 net loss widened to €8.2 million, or €0.22 per share, compared with €1.9 million, or €0.05 per share, a year earlier.
For full-year 2025, HIFU revenue grew 39% to a record €33.1 million, while company-wide revenue slipped 3% to €62.4 million. Net loss increased to €25.9 million, or €0.69 per share, and cash and cash equivalents declined to €17.4 million as of December 31, 2025.
The company reiterated 2026 revenue guidance of $72.0 million to $80.0 million, with core HIFU revenue expected between $50.0 million and $54.0 million, representing 34% to 45% year-over-year growth in its core HIFU business.
EDAP TMS S.A. filed a Form 8-K to share that it is presenting at the Oppenheimer 36th Annual Healthcare MedTech & Services Conference, with its investor presentation furnished as an exhibit and webcast through the investor section of its website.
The presentation highlights EDAP as a global leader in therapeutic ultrasound, focused on prostate cancer and other benign diseases. It emphasizes the large market of about 1.5 million new prostate cancer cases per year, the role of its Focal One robotic HIFU system as an organ-preserving treatment, and strong supporting clinical evidence versus surgery and radiation.
EDAP also showcases favorable U.S. Medicare reimbursement for HIFU procedures, growing global adoption of Focal One with 87 systems installed as of December 31, 2025, accelerating procedure and installation growth rates between 2021 and 2025, and preliminary 2025 HIFU revenue trends with 2026 guidance referenced from a prior earnings release.
EDAP TMS S.A. reported changes to its Board of Directors. On February 10, 2026, director Glen French resigned from the Board and from the audit, compensation, and nominations committees, with the company stating his resignation was not due to any dispute or disagreement.
On February 11, 2026, David Horn was appointed to the Board to fill this vacancy and will serve on the audit and nominations committees. His appointment will be submitted to shareholders at the next annual Ordinary and Extraordinary General Meeting. EDAP highlights Mr. Horn’s senior leadership role at Seer, Inc. and his more than 20 years of healthcare investment banking experience at Morgan Stanley, as well as prior roles in medical devices and life sciences. The company issued a press release on February 12, 2026 detailing these board changes.
EDAP TMS S.A. filed a current report to note that it released a press release with select preliminary unaudited financial and operational results for the fourth quarter and full fiscal year ended December 31, 2025, along with select guidance for 2026. The press release is provided as Exhibit 99.1.
The company also prepared an investor Presentation for analysts and investors, furnished as Exhibit 99.2. The company states that the presentation information is summary in nature, should be read together with its other SEC filings and public announcements, and that the materials in Items 2.02 and 7.01 and Exhibits 99.1 and 99.2 are furnished rather than filed and therefore are not subject to certain Exchange Act and Securities Act liability provisions.