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EDAP TMS SA reports developments in robotic energy-based therapies and minimally invasive ultrasound medical devices. The company develops, manufactures, promotes, and distributes systems that combine imaging, robotics, and focused ultrasound, with news frequently centered on the Focal One robotic HIFU platform for prostate focal therapy.
Recurring EDAP updates include HIFU revenue, Focal One system placements, U.S. procedure volumes, clinical evidence for prostate cancer applications, FDA clearances, and product enhancements. News also covers the company’s non-core ESWL lithotripsy and Distribution activities, investor presentations, financial guidance, and board or committee changes affecting the France-based issuer’s Nasdaq-listed American depositary shares.
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.
EDAP TMS SA (Nasdaq: EDAP) announced the launch of their new Focal One i robotic HIFU system at the upcoming 120th American Urological Association Annual Meeting in Las Vegas (April 26-29, 2025). The enhanced system features expanded HIFUsion compatibility, including:
- PSMA PET scans integration
- ExactVu Micro-Ultrasound support
- AI-driven algorithms (Unfold AI and OnQ Prostate)
- Extended capabilities for Koelis 3D biopsy maps and DynaCAD Urology datasets
The system introduces streamlined workflows, onboard video libraries, and enables treatment streaming and recording capabilities. CEO Ryan Rhodes highlighted that the design improvements were based on customer feedback, emphasizing the demand for incorporating latest diagnostic imaging modalities and AI algorithms for personalized procedures. The system's digital interface enables remote proctoring and collaborative procedures, following Cleveland Clinic's successful first remote transatlantic Focal One treatment from Ohio to Abu Dhabi.
EDAP TMS (Nasdaq: EDAP) announces its largest-ever presence at the upcoming 120th American Urological Association (AUA) Annual Meeting, showcasing their Focal One Robotic HIFU platform. The event will feature expert-led demonstrations, semi-live procedures, and hands-on simulations.
Key highlights include the presentation of final results from the FARP Study, the first randomized clinical trial comparing focal ablation versus radical prostatectomy for early-stage prostate cancer. Dr. Ruben Olivares from Cleveland Clinic will present on the first-ever remote transatlantic Focal One Robotic HIFU procedure.
Prior to AUA, EDAP will host its first Robotic Focal HIFU Masterclass at USC's Keck School of Medicine on April 24-25th, 2025, featuring lectures, simulations, and live procedures. The event has attracted over 80 urologists and includes a keynote lecture by Prof. Sebastien Crouzet sharing insights from 3,000 Focal One procedures.
EDAP TMS reported record financial results for Q4 and full-year 2024, with notable growth in its HIFU business segment. The company achieved record full-year HIFU revenue of USD 25.7 million, up 15.3% from 2023, and Q4 HIFU revenue of USD 9.3 million, a 15% increase year-over-year.
Key highlights include a 51% growth in U.S. Focal One HIFU procedures in 2024, CE Mark approval for deep infiltrating endometriosis treatment, and positive outcomes from the HIFI study comparing Focal One® Robotic HIFU versus surgery in prostate cancer management. The company also initiated a Phase I/II study for Benign Prostatic Hyperplasia (BPH) treatment.
Financial results show total Q4 2024 revenue of USD 21.5 million, up 3.6% year-over-year, with a gross profit margin of 44.8%. The company reported a Q4 net loss of USD 2.1 million and held cash reserves of USD 30.9 million as of December 31, 2024.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has scheduled its Fourth Quarter and Full Year 2024 financial results announcement for March 27, 2025, before markets 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 Ryan Rhodes (CEO), Ken Mobeck (CFO), and François Dietsch (Chief Accounting Officer). Interested parties can access the call through domestic (1-800-225-9448) or international (1-203-518-9708) dial-in numbers using the passcode EDAP.
EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, has appointed Glen French to its Board of Directors. French brings over 25 years of experience in medical device development and commercialization.
French's notable achievements include co-founding and selling three medical device companies and taking a fourth public. As CEO of Pulmonx (NASDAQ: LUNG), he led the company to over 20% compound annual revenue growth and a successful IPO raising $218.5 million. He previously served as President of Pulmonary Endoscopy at Boston Scientific and held CEO positions at Asthmatx and Broncus Technologies.
The appointment aims to support EDAP's strategic growth of its Focal One robotic HIFU technology platform, which targets prostate cancer treatment with potential applications in endometriosis, benign prostatic hyperplasia, and pancreatic cancer.
Cortechs.ai and EDAP TMS (NASDAQ: EDAP) announced the world's first successful OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the UCSF Prostate Cancer Center. The procedure, performed on January 28th, 2025, marks the first clinical application of OnQ Prostate's RSI technology in focal therapy.
OnQ Prostate, the only FDA-cleared solution for RSI-MRI, provides detailed tissue microstructure information to help urologists identify suitable candidates for focal therapy and target specific lesions. The technology integrates with focal therapy systems for real-time precision targeting during procedures.
Dr. Matthew R. Cooperberg, who performed the procedure, noted that OnQ Prostate clearly delineated tumor anatomy and helped map out a complex treatment plan. The technology aims to improve and standardize prostate MRI interpretation across various contexts in prostate cancer treatment.
EDAP TMS SA (Nasdaq: EDAP), a leader in robotic energy-based therapies, announced preliminary record sales for its Focal One® System in Q4 2024.
The company reported worldwide sales of 11 Focal One Systems, a record for the fourth quarter. In the U.S., both system sales and procedures reached record highs, with a 30% year-over-year growth in procedures.
According to CEO Ryan Rhodes, the strong performance reflects the growing adoption of Focal One Robotic HIFU technology, which is changing how urologists manage prostate cancer. The recent publication of the HIFI study in European Urology is expected to further boost awareness and adoption.
Entering 2025, EDAP anticipates continued growth in the adoption of Focal One technology by urology practices. The preliminary data is subject to final financial reporting processes, with final Q4 results expected in March.
EDAP TMS SA (Nasdaq: EDAP) has appointed Joshua H. Levine to its Board of Directors. Levine brings extensive executive experience in the medical technology sector, with a proven track record of growing shareholder value through transformative business strategies.
Levine previously served as President, CEO, and Director of Accuray Incorporated (2012-2022), where he led a turnaround resulting in consistent top-line growth and positive operating profit. His prior roles include CEO positions at Immucor Inc. (acquired by TPG Capital for $2 billion) and Mentor (acquired by Johnson & Johnson for $1.2 billion).
The appointment comes as EDAP continues to expand its Focal One robotic HIFU platform, which is transforming prostate cancer treatment. The company aims to extend this technology to other therapeutic areas, including endometriosis and BPH.
EDAP TMS SA (NASDAQ: EDAP) has announced the successful treatment of the first patient in a phase I/II PULS Trial evaluating their proprietary High Intensity Focused Ultrasound (HIFU) technology for pancreatic tumors. The trial, sponsored by Centre Léon Bérard in Lyon, France, aims to assess both the tolerance and preliminary efficacy of intraoperative HIFU intervention on pancreatic lesions.
The first procedure was completed as planned, with the patient discharged without complications. This development represents a potential new treatment option for locally advanced pancreatic cancer patients, who currently have treatment options beyond chemotherapy and radiotherapy.
The trial's significance is highlighted by pancreatic cancer statistics: a five-year survival rate of just 11.5% across all stages (2012-2018 data), with 62,210 projected new cases and 49,830 projected deaths in the U.S. for 2022. Pancreatic cancer remains the third leading cause of cancer deaths, after lung and colorectal cancers.