Edap Tms Stock Price, News & Analysis

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.

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.