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 SA director Joshua Levine filed an initial ownership report showing beneficial ownership of 25,000 shares of common stock, held directly, as of January 1, 2026. This Form 3 filing establishes his starting ownership position as a director, and does not report any new purchase or sale transactions.
EDAP TMS SA executive Shah Sanket, the company’s General Counsel and Corporate Secretary, filed an initial ownership report showing beneficial ownership of stock options. The filing reports 125,000 stock options to acquire EDAP TMS SA common stock, held directly.
The options were granted on September 30, 2025, with a vesting schedule where one-sixth becomes exercisable on the six-month anniversary of the grant date, and the remaining portion vests monthly through the third anniversary of the grant. The options have an exercise price of $2.41 per share, converted from 2.05 euros using an exchange rate of EUR 1 to USD 1.1750.
EDAP TMS S.A. (EDAP) reported that the U.S. Food and Drug Administration has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system used in robotic focal therapy for prostate cancer. The clearance covers advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the recently launched Focal One i platform.
EDAP states that the next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. Management describes this as an important technical milestone that further strengthens Focal One’s product roadmap and reinforces its global leadership positioning in focal therapy.
EDAP TMS (EDAP) highlights its position as a global leader in robotic high-intensity focused ultrasound (HIFU) for prostate cancer, BPH and endometriosis, supported by growing clinical use and reimbursement. The company reports revenue of
EDAP remains loss-making, with operating loss of
EDAP TMS (EDAP) reported third-quarter 2025 results highlighting continued momentum in its HIFU franchise. HIFU revenue was
Profitability metrics improved: gross profit was
Management reiterated 2025 guidance: core HIFU revenue growth of
EDAP TMS S.A., a France-based company, filed a Form S-8 registration statement to register equity awards under two employee incentive plans: the 2025-2 Restricted Stock Unit (Free Share) Plan and the 2025 Share Subscription Option Plan. These plans are designed to grant free shares and share options to eligible participants, aligning their interests with the company’s long-term performance.
The filing incorporates by reference EDAP’s 2024 annual report on Form 20-F and certain Form 6-K reports, so future SEC filings will automatically update the information used for the plans. The company also describes director and officer liability insurance consistent with French law and includes standard SEC undertakings and signatures from senior executives and directors authorizing the registration.
EDAP TMS reports that its Q2 2025 revenue rose to
By segment for the quarter, HIFU revenue reached
The company highlights more than 350 Focal One HIFU clinical sites and 73 systems in the U.S. at the end of Q2 2025, strong reimbursement for HIFU procedures, and expanding clinical programs in prostate cancer, benign prostatic hyperplasia, and endometriosis.
EDAP TMS reported a major milestone as the French Ministry of Health granted national reimbursement for its Focal One robotic High Intensity Focused Ultrasound (HIFU) procedure to treat prostate cancer. Coverage in France applies to eligible patients both as a primary treatment for localized prostate cancer and as a salvage option after radiotherapy. This makes the non-invasive Focal One therapy accessible under France’s universal Social Security system.
The company links this decision to positive clinical evidence from the HIFI Study sponsored by the French Urology Association, as well as Level 1 evidence from the FARP Study presented at the American Urological Association meeting. Reimbursement became effective on September 1, 2025. Management believes that winning reimbursement in one of Europe’s largest healthcare markets may help support future reimbursement decisions in other European countries and drive broader adoption of Focal One.
EDAP TMS SA reported strong commercial momentum in HIFU (high-intensity focused ultrasound), with Focal One net placements up +140% year-over-year and HIFU revenue up 76.8% year-over-year. Management raised 2025 HIFU revenue growth guidance to a 26%–34% range from a prior 16%–25% range, and executed a letter of intent with the European Investment Bank for a €36 million credit facility to support HIFU growth and strategic expansion.
The company announced it will become a U.S. domestic filer effective January 1, 2026, beginning SEC reporting and Nasdaq requirements. Additional milestones include presentation of positive 3-year randomized controlled trial outcomes for focal ablation versus radical prostatectomy and the launch of the new Focal One i Robotic HIFU System.
EDAP TMS entered into a letter of intent for a EUR 36 million credit facility with the European Investment Bank to support its robotic energy-based therapy business. The funding is intended to expand adoption of the Focal One® Robotic HIFU system in focal therapy for early-stage prostate cancer and to accelerate development of new clinical indications. Pending final legal documentation, the facility is expected to close no later than the end of calendar year 2025 and is described as low-interest funding that can be drawn in tranches as needed.