Edap Tms Stock Price, News & Analysis

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 reported Q1 2025 financial results, highlighting record Focal One® Robotic HIFU System placements with nine systems installed. Key developments include: CE Mark approval for Focal One in treating deep infiltrating endometriosis, positive final results from the FARP randomized trial showing non-inferiority to radical prostatectomy, and launch of the new Focal One i Robotic HIFU System. Financial results showed HIFU revenue increased 6.8% to €6.2M, while total revenue decreased 9.1% to €13.6M. The company reported a net loss of €7.1M (€0.19 per share) compared to €4.5M loss in Q1 2024. Cash position stood at €22.8M as of March 31, 2025. EDAP maintains its 2025 guidance of 16-25% growth in core HIFU business.

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.

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.