Welcome to our dedicated page for Edap Tms SEC filings (Ticker: EDAP), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The EDAP TMS SA (Nasdaq: EDAP) SEC filings page on Stock Titan provides centralized access to the company’s Form 6-K current reports and other U.S. regulatory disclosures. EDAP uses these filings to report unaudited quarterly financial results, business updates and material agreements related to its robotic energy-based therapies and High-Intensity Focused Ultrasound (HIFU) platforms.
In its 6-K filings, EDAP presents condensed consolidated statements of operations and balance sheets, detailing revenue from sales of medical equipment, recurring revenue programs and leases, and sales of spare parts, supplies and services. These filings break out performance in the company’s core HIFU business and non-core ESWL and Distribution segments, and include information on gross profit, operating expenses, operating loss and net loss. They also provide narrative discussion of HIFU revenue growth, system placements and procedure volumes.
EDAP’s SEC reports are also the primary source for regulatory and strategic disclosures. Recent 6-Ks describe the company’s transition from foreign private issuer status to U.S. domestic filer status, effective January 1, 2026, and outline the implications for SEC reporting and Nasdaq listing requirements. Other filings disclose a multi-tranche credit facility with the European Investment Bank, including the intended use of proceeds to expand the Focal One Robotic HIFU platform and develop new clinical indications.
Regulatory filings incorporate full text of press releases on topics such as FDA 510(k) clearance for enhancements to the Focal One HIFU system, reimbursement decisions in France for Focal One Robotic HIFU procedures in prostate cancer, and recognition of the Focal One platform by professional societies. These documents also reference key clinical studies, including the HIFI and FARP trials, as part of the company’s description of its clinical evidence base.
On Stock Titan, EDAP filings are supplemented with AI-powered summaries that highlight the main points of each document, helping readers quickly identify changes in revenue guidance, financing arrangements, reimbursement developments or reporting status. Users can review new filings as they are posted to EDGAR and revisit historical 6-Ks and other forms to analyze how EDAP’s HIFU-focused strategy, financial profile and regulatory environment have evolved over time.
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 S.A. registers the resale by a selling securityholder of 4,574,421 warrants to purchase up to 4,574,421 ordinary shares (which may be represented by ADSs) pursuant to a prospectus supplement under Rule 424(b)(3), to satisfy obligations under the Warrant Agreement.
The company states it will not receive proceeds from resale by the selling securityholder, except to the extent the selling securityholder exercises the warrants for cash; proceeds from any cash exercises are intended for general corporate purposes, including working capital. Shares outstanding were 37,751,519 ordinary shares as of March 25, 2026.
EDAP TMS S.A. files Pre-Effective Amendment No. 1 to its Registration Statement (File No. 333-294597), submitting an opinion of Jones Day as Exhibit 5.1. The amendment is exhibit-only; the prospectus and the balance of Part II are unchanged.
The filing includes an exhibit index listing corporate charters, deposit agreements, warrants, financing documents with the European Investment Bank, consents, and the calculation of filing fee table. The registration statement is signed by management on March 27, 2026.
EDAP TMS S.A. filed a shelf registration to offer up to $125,000,000 of securities, including ordinary shares (ADSs), preferred shares and warrants, with specific terms to be set in prospectus supplements.
As of March 25, 2026, the company reported 37,751,519 issued ordinary shares outstanding. The prospectus also includes a resale prospectus for up to 4,574,421 warrants and 4,574,421 ADSs related to those warrants; separate warrants issued to the European Investment Bank total 2,624,421 to date, with additional estimated issuances described for future borrowings under a €36.0 million credit facility.
EDAP TMS S.A. files its annual report outlining a focused shift to its Focal One high‑intensity focused ultrasound platform and a winding down of new ESWL system sales. The company positions Focal One as a non‑invasive alternative to surgery and radiation in localized prostate cancer, with growing evidence and new FDA 510(k) clearances, including the Focal One i System in November 2025.
EDAP is pursuing expanded indications in benign prostatic hyperplasia and endometriosis, supported by multiple clinical studies showing non‑inferior cancer control and better functional outcomes versus surgery or radiation in selected patients. As of December 31, 2025, the HIFU division held 71 granted patents across 14 families, with expirations extending to 2045.
The company reports $61,845,277 in aggregate market value of non‑affiliate equity as of June 30, 2025 and 37,481,986 ordinary shares outstanding as of March 25, 2026. Liquidity and leverage are key themes: cash and cash equivalents were $20.5 million, down $10.5 million year over year, against $24.5 million of total indebtedness, and EDAP plans to draw a €12.0 million tranche under its €36.0 million European Investment Bank credit facility while retaining potential access to an additional €13.0 million tranche subject to covenants and milestones.
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 director David R. Horn filed an initial insider ownership report stating that he beneficially owns no securities of the company. The Form 3 identifies him as a director only, with no derivative or non-derivative holdings reported and notes a power of attorney appointment.
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.