Welcome to our dedicated page for Edap Tms news (Ticker: EDAP), a resource for investors and traders seeking the latest updates and insights on Edap Tms stock.
EDAP TMS SA (Nasdaq: EDAP) is described in its filings and press releases as a global leader in robotic energy-based therapies, focused on High-Intensity Focused Ultrasound (HIFU) and related ultrasound-based medical devices. The EDAP news feed on Stock Titan aggregates company announcements, financial updates and regulatory disclosures so readers can follow developments around its Focal One Robotic HIFU platform and broader therapeutic ultrasound portfolio.
Recent news from EDAP highlights HIFU revenue growth, system placements and procedure volumes, as well as guidance on expected revenue trends in its core HIFU business and non-core ESWL and Distribution segments. The company regularly reports unaudited quarterly financial results via Form 6-K, including details on sales of medical equipment, recurring revenue programs, and spare parts and services, along with commentary on gross margins and operating performance.
Investors and healthcare observers can also use the news stream to track regulatory milestones and clinical adoption. EDAP has announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, as well as reimbursement in France for Focal One Robotic HIFU procedures in prostate cancer under the national universal health system. News items further cover recognition such as an Industry Award for Innovations in Endourological Instrumentation for the Focal One platform.
Other news categories include financing and capital structure updates, such as a multi-tranche credit facility with the European Investment Bank intended to support expansion of the Focal One platform, and information about EDAP’s transition from foreign private issuer to U.S. domestic filer status. Coverage of conference presentations and investor meetings provides additional context on how management presents the company’s strategy in urology, prostate cancer and benign disease markets.
By reviewing the EDAP news page, readers can follow company-reported trends in HIFU adoption, reimbursement developments, clinical evidence references and financial guidance, all drawn from EDAP’s own press releases and SEC-reported materials.
EDAP (Nasdaq: EDAP) reported preliminary unaudited results showing record fourth-quarter and full-year 2025 HIFU revenue driven by increased Focal One system sales and growing U.S. procedure volume. Q4 2025 HIFU revenue is expected to be $12.9M–$13.3M and full-year 2025 HIFU revenue $36.7M–$37.2M, both company records. Q4 included a record 15 Focal One system placements and ~28% YoY growth in U.S. Focal One procedures. EDAP issued 2026 guidance of $50.0M–$54.0M HIFU revenue (36%–38% YoY growth) and combined non-core revenue of $22.0M–$26.0M. Results are preliminary and unaudited; final 2025 results expected in March 2026.
EDAP (Nasdaq: EDAP) announced that the U.S. Food and Drug Administration granted 510(k) clearance on November 20, 2025 for ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system.
The clearance covers an upgraded ultrasound imaging engine, streamlined treatment planning and an optimized user interface for the Focal One i, enabling real-time visualization and supporting potential future AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation.
Company commentary cites this clearance as a technical milestone that reinforces Focal One’s market leadership in robotic focal therapy for prostate cancer.
EDAP (Nasdaq: EDAP) will present at the Piper Sandler 37th Annual Healthcare Conference in New York City on Tuesday, December 2, 2025. Chief Executive Officer Ryan Rhodes will deliver a fireside discussion at 10:30–10:55 am ET, and CEO Rhodes together with Chief Financial Officer Ken Mobeck will host one-on-one investor meetings the same day.
Location: The Lotte New York Palace. A live webcast and archived replay will be available via the conference link https://event.webcasts.com/starthere.jsp?ei=1743759&tp_key=aa01607b94 and in the Investors section of the company website.
EDAP (Nasdaq: EDAP) reported third-quarter 2025 results on November 6, 2025, with total revenue €13.9M (US $16.1M), up 6% year over year. The HIFU business drove growth: Q3 HIFU revenue was €6.7M (US $7.7M), +49% YoY, supported by six Focal One system sales and a 15% rise in U.S. procedures. System placements rose 167% YoY. Gross profit was €6.0M and gross margin improved to 43%. Q3 net loss narrowed to €5.0M (loss €0.13/share). The company closed a €36M EIB credit facility (first tranche €11M received) to support Focal One expansion and reiterated 2025 guidance for core HIFU revenue growth of 26–34%.
EDAP (Nasdaq: EDAP) will present at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025. Ryan Rhodes, Chief Executive Officer, is scheduled to deliver a presentation and host 1x1 investor meetings from 4:30–4:55 pm GMT at the Waldorf – Aldwych, Entresol Level.
A live webcast will be available on the conference webcast page and an archived replay will be accessible in the company’s Investors section.
EDAP (Nasdaq: EDAP) will participate in the UBS Global Healthcare Conference held November 10-13, 2025 in Palm Beach Gardens, Florida. CEO Ryan Rhodes and CFO Ken Mobeck are scheduled to host one-on-one investor meetings on Monday, November 10, 2025 at PGA National Resort Hotel.
Meetings are 1x1 investor sessions; registration is via UBS for clients or through a UBS sales representative.
EDAP (Nasdaq: EDAP) will release third quarter 2025 financial results for the period ended September 30, 2025, before market open on Thursday, November 6, 2025.
The company will host a conference call and webcast on November 6, 2025 at 8:30 am EST featuring Ryan Rhodes (CEO), Ken Mobeck (CFO), and François Dietsch (Chief Accounting Officer). Domestic and international dial-in numbers and a webcast registration link are provided for investor access.
EDAP (Nasdaq: EDAP) entered a €36 million multi-tranche credit facility with the European Investment Bank to fund global expansion of its Focal One Robotic HIFU platform and to accelerate development of new clinical indications. The facility is callable in three tranches: Tranche A €11M (8%), Tranche B €12M (7%), and Tranche C €13M (6%), each with a 5-year maturity from disbursement. EDAP expects to draw the first tranche of €11 million in Q4 2025. As additional remuneration, EDAP will issue warrants to the EIB tied to each tranche. Proceeds will support commercialization for prostate cancer and endometriosis indications and related clinical development.
EDAP TMS SA (Nasdaq: EDAP) highlighted its Focal One Robotic HIFU treatment for prostate cancer through a national television feature on Health Uncensored with Dr. Drew on the Lifetime Network. The segment, aired on September 26, 2025, featured patient Peter D. from Austin, TX, sharing his successful treatment experience.
The broadcast was part of EDAP's Prostate Cancer Awareness Month campaign, which included multiple patient education events and hospital partnerships. Dr. Eric Giesler from Urology Austin emphasized how Focal One provides a non-invasive treatment option that precisely targets prostate cancer while minimizing side effects compared to traditional radical treatments like surgery and radiotherapy.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has received the prestigious 2025 Industry Award for Innovations in Endourological Instrumentation from the Endourological Society for its Focal One High-Intensity Focused Ultrasound (HIFU) platform.
The award, presented at the 42nd World Congress of Endourology and Uro-Technology, recognizes Focal One as the first Focal Therapy technology to receive this distinction. The platform was honored for its pioneering development in robotic HIFU for prostate cancer treatment.
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