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.
EDAP TMS SA filings document a France-based medical-device issuer with Nasdaq-listed American depositary shares, each representing one ordinary share. Its current reports cover operating results for the HIFU business, Focal One robotic HIFU system sales and procedure trends, ESWL and Distribution revenue, investor presentation materials, and product regulatory updates such as FDA 510(k) clearances for Focal One enhancements.
The company’s SEC disclosures also record capital-structure and financing matters, including a European Investment Bank credit facility and related warrants to purchase ordinary shares. Governance filings address board composition, committee assignments, and shareholder-vote matters, while foreign-issuer reports provide formal disclosure around EDAP’s therapeutic ultrasound strategy, risk statements, and public-company reporting obligations.
EDAP TMS SA director Glendon E. French III filed an initial insider ownership report on Form 3. The filing states that no securities of EDAP TMS SA are beneficially owned by the reporting person as of the event date. This means the director reports holding no EDAP shares or derivative securities at the time covered by this filing.
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 $16.1 million for the three months ended September 30, 2025, up from $14.4 million, with gross margin improving to 43.0% from 39.4%. HIFU revenue rose to $7.7 million from $4.9 million, while distribution and ESWL lines declined.
EDAP remains loss-making, with operating loss of $5.7 million and net loss of $5.8 million for the quarter, slightly better than a year earlier. For the nine-month period, revenue was $48.8 million with net loss of $19.8 million. Cash and cash equivalents were $12.4 million as of September 30, 2025. The company reports 76 Focal One systems installed in the U.S. and emphasizes expanding indications, strong clinical evidence, and favorable Medicare reimbursement as foundations for future growth.
EDAP TMS (EDAP) reported third-quarter 2025 results highlighting continued momentum in its HIFU franchise. HIFU revenue was €6.7 million (US $7.7 million), up 49% year over year, as Focal One system sales doubled to six and U.S. procedures rose 15%. Total revenue reached €13.9 million (US $16.1 million), up 6% from the prior year period.
Profitability metrics improved: gross profit was €6.0 million with a 43% margin versus 39% a year ago, while operating loss narrowed to €4.9 million and net loss to €5.0 million (€0.13 per share) from €6.4 million (€0.17 per share). Year-to-date, HIFU revenue was €21.3 million, up 42%, and total revenue was €43.5 million, down 0.7%. Cash and cash equivalents were €10.6 million as of September 30, 2025.
Management reiterated 2025 guidance: core HIFU revenue growth of 26%–34%, with non-core ESWL and Distribution revenue declining 25%–30%. The company also finalized a €36 million European Investment Bank credit facility, with €11 million from the first tranche received.
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 $18.4M from $17.0M a year earlier, driven by strong growth in its Focal One robotic HIFU prostate cancer business. Gross profit increased to $7.8M, with gross margin improving to 42.5% from 37.5%, while operating loss held at $(6.6)M. Net loss was $(6.4)M, or $(0.17) per share.
By segment for the quarter, HIFU revenue reached $9.7M (up 89%), ESWL was $1.8M (down 27%), and distribution revenue was $6.9M (down 26%). As of June 30, 2025, cash and cash equivalents were $19.1M versus $32.4M a year earlier, and shareholders’ equity was $32.7M versus $51.0M.
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.