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 TMS SA (Nasdaq: EDAP) has achieved a significant milestone with the French Ministry of Health granting reimbursement coverage for its Focal One Robotic HIFU (High Intensity Focused Ultrasound) procedure for prostate cancer treatment in France. The coverage, effective September 1, 2025, includes both primary treatment of localized prostate cancer and salvage treatment following radiotherapy under France's national universal health system.
The reimbursement approval was supported by positive results from the HIFI Study and additional evidence from the FARP Study. CEO Ryan Rhodes highlighted that this achievement could accelerate similar reimbursement approvals across other European countries and drive further adoption of the Focal One platform.
EDAP TMS SA (NASDAQ: EDAP) reported strong Q2 2025 results, highlighted by exceptional growth in its core HIFU business. The company achieved 76.8% year-over-year HIFU revenue growth to EUR 8.5 million, driven by nine Focal One system sales versus three in Q2 2024. Total revenue reached EUR 16.0 million, up 1.6% year-over-year.
Key developments include a 36 million Euro credit facility letter of intent with the European Investment Bank and increased 2025 HIFU revenue growth guidance to 26-34% from previous 16-25%. The company reported a Q2 2025 net loss of EUR 5.6 million (EUR 0.15 per share), improved from EUR 6.1 million loss in Q2 2024.
EDAP's strategic focus on its high-margin HIFU business resulted in improved gross margins of 42.5% in Q2 2025, up from 37.5% in Q2 2024, while the company continues planned reduction of non-core ESWL and Distribution operations.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has secured a letter of intent for a €36 million credit facility from the European Investment Bank (EIB). The financing will support the expansion of Focal One® Robotic HIFU technology for early-stage prostate cancer treatment and accelerate development of new clinical indications.
The credit facility, expected to close by the end of 2025, will provide low-interest funding accessible in tranches. CEO Ryan Rhodes highlighted that this strategic financing will strengthen EDAP's balance sheet and help expand access to Focal One Robotic HIFU technology for physicians and patients.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. CEO Ryan Rhodes will engage in a fireside chat and conduct one-on-one investor meetings during the event.
The presentation is scheduled for Tuesday, September 9th, 2025, from 8:30-9:00 AM ET at the Lotte New York Palace Hotel. Investors can access both the live and archived webcast through the company's investor relations website.
EDAP TMS (NASDAQ:EDAP), the global leader in robotic energy-based therapies, will release its Q2 2025 financial results on Thursday, August 28th, 2025, before market open.
The company will host a conference call and webcast at 8:30 AM EDT on the same day, featuring CEO Ryan Rhodes, CFO Ken Mobeck, and CAO François Dietsch. Investors can access the call via domestic (1-800-274-8461) or international (1-203-518-9814) numbers using passcode EDAP, or through the company's webcast platform.
EDAP TMS (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced its transition from foreign private issuer status to U.S. domestic filer status, effective January 1, 2026.
The transition will require EDAP to comply with SEC reporting rules and Nasdaq listing requirements applicable to U.S. domestic filers, including new requirements regarding board composition, corporate governance matters, and shareholder approval processes. CEO Ryan Rhodes emphasized this change as a significant milestone that demonstrates the company's commitment to transparency and regulatory best practices.
EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, has announced its participation in the upcoming Jefferies Global Healthcare Conference. CEO Ryan Rhodes will deliver a presentation and conduct one-on-one investor meetings during the conference, scheduled for June 3-5, 2025, in New York City.
Rhodes' presentation is set for Thursday, June 5th, from 4:20-4:50 PM ET. Investors can access both the live and archived webcast of the presentation through the company's website's Investor section or via the provided webcast link.
EDAP TMS SA (NASDAQ: EDAP), a global leader in robotic energy-based therapies, has scheduled its first quarter 2025 financial results announcement for May 15, 2025, before market open. The company will host a conference call and webcast at 8:30 AM EDT on the same day.
The earnings discussion will be led by CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch. Investors can join via phone using the domestic line (1-800-267-6316) or international line (1-203-518-9783) with passcode "EDAP", or through the webcast platform.
EDAP TMS announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) randomized controlled trial at the 120th AUA Annual Meeting. The study compared ultrasound energy-based focal ablation against Robotic Prostatectomy for prostate cancer treatment.
Key findings from the 213-patient trial:
- Focal Ablation showed a treatment failure rate of 5.6% vs 7.9% for Radical Prostatectomy
- 25% of Radical Prostatectomy patients switched to Focal Ablation
- Both groups showed similar patient characteristics in age, PSA levels, and tumor metrics
The study achieved its primary endpoint, demonstrating that Focal One Robotic HIFU treatment is non-inferior to radical surgery at the 36-month follow-up. This breakthrough validates focal ablation's role in prostate cancer management, with results showing better treatment success rates compared to traditional surgery.
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