EDAP TMS S.A. (NASDAQ:EDAP) is a pioneering global medical technology company specializing in the development, manufacturing, and commercialization of cutting-edge robotic and energy-based therapies for urology and oncology. Founded in 1979 and headquartered in Lyon, France, EDAP has built a four-decade legacy as a leader in therapeutic ultrasound innovations. The company is best known for introducing High-Intensity Focused Ultrasound (HIFU) as a revolutionary, non-invasive treatment for prostate cancer, transforming the way physicians approach focal therapy and organ-preserving interventions. With a strong research foundation and global reach, EDAP has positioned itself as a trusted innovator at the intersection of robotics, imaging, and therapeutic energy, offering technologies that improve precision, reduce recovery time, and enhance patient quality of life.
At the heart of EDAP’s innovation is its flagship product, the Focal One® Robotic HIFU platform — the first and only fully robotic, image-guided HIFU system designed for the precise ablation of prostate tissue. Focal One® integrates real-time ultrasound, MRI, and 3D biopsy mapping to deliver unparalleled accuracy in tumor targeting, setting a new benchmark for personalized prostate cancer therapy. This breakthrough technology provides patients with a non-invasive alternative to radical surgery or radiation, offering shorter recovery times and minimal side effects, while giving clinicians advanced control over treatment planning and execution. The company’s commitment to continuous innovation has earned it recognition as the global leader in robotic energy-based focal therapies, serving as the catalyst for a growing paradigm shift in prostate cancer management worldwide.
In addition to its leadership in HIFU, EDAP maintains a robust portfolio of medical technologies across the urology spectrum. Its extracorporeal shock wave lithotripsy (ESWL) systems remain a cornerstone for non-invasive treatment of kidney stones, while its ultrasound diagnostic and therapy devices serve a variety of clinical applications. By combining robotics, energy-based therapy, and advanced imaging integration, EDAP has created a comprehensive ecosystem of solutions that bridge the gap between precision engineering and real-world medical practice. The company’s long-standing partnerships with hospitals, research institutions, and clinical networks have enabled widespread adoption of its technologies in over 50 countries, reinforcing its role as a global standard-bearer in minimally invasive urologic care.
EDAP’s expansion into the United States and other major global markets has accelerated over the past decade, fueled by rising demand for focal therapy and the increasing acceptance of HIFU as a viable alternative to conventional treatments. The company’s U.S. operations, headquartered in Austin, Texas, have played a crucial role in driving adoption among leading medical centers and urology specialists. As reimbursement coverage and clinical awareness continue to expand, EDAP’s footprint in North America is poised for exponential growth. The company’s ongoing investment in education, awareness, and clinical collaboration demonstrates its long-term commitment to transforming patient outcomes through innovation and technology.
With a clear mission to redefine how localized cancers are treated, EDAP TMS stands at the forefront of the global movement toward minimally invasive, patient-centered medicine. Its unique combination of robotic precision, energy-based therapy, and imaging-guided accuracy continues to push the boundaries of what is possible in modern urology. As the demand for personalized, non-invasive treatment solutions grows, EDAP’s pioneering work in robotic HIFU positions it not only as a market leader but also as a driving force shaping the future of medical technology in the 21st century.
The third quarter of 2025 marked a transformative period for EDAP, with 167% year-over-year growth in Focal One® system placements and 15% growth in U.S. procedure volumes, underscoring the clinical momentum of HIFU technology in minimally invasive prostate cancer management. These results reaffirm EDAP’s leadership in focal therapy, the fastest-growing segment in early-stage prostate cancer treatment. The company’s unique blend of robotic precision, real-time imaging, and non-invasive energy-based ablation continues to gain traction as physicians and patients increasingly seek alternatives to traditional surgery and radiation.
EDAP’s third quarter revenue reached €13.9 million (US $16.1 million), a 6% overall increase year-over-year, driven primarily by the success of its HIFU business. Gross profit climbed to €6.0 million (US $6.9 million), with margins improving to 43% compared to 39% in the prior year, reflecting a favorable shift toward high-margin HIFU procedures and system sales.
Focal One® HIFU Platform: Driving a Paradigm Shift in Prostate Cancer Care
At the heart of EDAP’s success is its flagship Focal One® Robotic HIFU system, the world’s most advanced platform for precise, non-invasive ablation of prostate tissue. Focal One integrates three critical imaging modalities—ultrasound, MRI, and 3D modeling—to enable personalized, targeted prostate cancer therapy with minimal side effects. Its robotic guidance system ensures sub-millimeter precision, delivering maximum efficacy while preserving urinary and sexual function—two key patient outcomes that traditional surgery often compromises.
The company’s commercial success is underpinned by an accelerating shift in prostate cancer management toward minimally invasive focal therapy. According to CEO Ryan Rhodes, “More urologists want to offer their patients both an effective and non-invasive treatment option for early-stage prostate cancer.” This global trend has translated directly into growing sales and higher procedure volumes, especially in the U.S., where expanded insurance coverage and hospital adoption are unlocking significant market potential.
In the third quarter, EDAP sold six Focal One systems, doubling the number from the same period in 2024. The company also achieved a 9% increase in worldwide disposables revenue, supported by a double-digit increase in procedure volumes in the U.S. These results reinforce the growing clinical acceptance of HIFU as a mainstream treatment modality and position EDAP as the leading innovator in robotic focal therapy.
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Strengthening Financial Position and European Investment Bank Partnership
Beyond strong revenue growth, EDAP demonstrated strategic financial discipline and expanded its funding capacity to support global expansion. The company finalized a €36 million credit facility with the European Investment Bank (EIB), providing long-term capital to accelerate commercialization of Focal One® and support new clinical indications in urology and oncology. The first tranche of €11 million has already been received, enhancing liquidity and providing flexibility for R&D and marketing investments in 2026.
This partnership with the EIB underscores institutional confidence in EDAP’s technological leadership and growth trajectory. It also provides a clear runway to fund expansion in key global markets—including the U.S., Europe, and Asia—where rising prostate cancer incidence rates and demand for non-invasive options are fueling adoption of HIFU technology.
Global Recognition and Awareness Campaigns Strengthen Brand Equity
EDAP’s momentum extends beyond financial performance—it is gaining recognition from both the medical community and the general public. In September 2025, the company’s Focal One® technology was honored with the 2025 Industry Award for Innovations in Endourological Instrumentation by the Endourological Society at the 42nd World Congress of Endourology and Uro-Technology. This award highlights EDAP’s groundbreaking contribution to the field of urology and further validates Focal One® as the most advanced focal therapy system available today.
Additionally, EDAP’s Prostate Cancer Awareness Month campaign, which aired nationally on Lifetime Network’s “Health Uncensored with Dr. Drew,” reached millions of viewers across the U.S. The campaign featured interviews with patients treated using Focal One®, emphasizing real-world success stories and promoting awareness of focal therapy as a superior treatment option. These outreach initiatives, combined with hospital partnerships and patient education programs, continue to elevate EDAP’s brand presence among both clinicians and patients.
Financial Highlights and Performance Outlook
EDAP’s HIFU segment remains the company’s primary growth driver, delivering €21.3 million (US $23.9 million) in revenue for the first nine months of 2025—a 42% year-over-year increase. In contrast, its legacy non-core businesses in ESWL (lithotripsy) and distribution saw a 23% decline, reflecting EDAP’s strategic pivot toward high-growth, high-margin robotic therapies.
The company’s total year-to-date gross profit improved to €18.5 million (US $20.7 million), representing a 42.5% margin, compared to 39.9% in 2024. Operating expenses remained stable at €35.2 million (US $39.4 million), demonstrating operational discipline despite an expanding commercial footprint. Net loss for the nine-month period was €17.7 million (US $19.8 million), or (€0.47) per share, slightly higher than 2024, primarily due to reinvestment in R&D and sales infrastructure.
Looking ahead, EDAP reaffirmed its 2025 guidance, projecting 26%–34% growth in core HIFU revenue while non-core segments are expected to decline as the company transitions toward its next phase of robotic therapy dominance.
A Multi-Billion-Dollar Opportunity in Minimally Invasive Oncology
EDAP’s growth trajectory aligns perfectly with the global healthcare shift toward precision medicine and non-invasive therapies. The global prostate cancer treatment market is estimated to exceed $13 billion by 2030, with focal therapy expected to be the fastest-growing segment. As Focal One® continues to gain traction, EDAP is ideally positioned to capture market share from traditional modalities like surgery and radiation.
The company’s pipeline expansion into new indications—such as kidney, liver, and gynecological applications—could further multiply its addressable market. Combined with AI-driven imaging advancements and next-generation robotics, EDAP’s technology platform could evolve into a standard of care for organ-preserving cancer therapy worldwide.
Conclusion: EDAP’s Growth Story Is Just Beginning
EDAP TMS S.A. (NASDAQ: EDAP) stands at the forefront of the medical technology revolution. Its record-breaking 49% HIFU revenue growth, expanding U.S. procedure volumes, and growing global recognition highlight a company entering a sustained phase of commercial acceleration. The Focal One® system is not merely a device—it represents a paradigm shift in how prostate cancer is treated, combining robotic precision, imaging integration, and minimally invasive efficiency.
With robust financial backing, a strong innovation pipeline, and a clear market focus, EDAP is emerging as a category-defining leader in robotic focal therapy. For long-term investors seeking exposure to medical robotics, oncology innovation, and AI-powered healthcare solutions, EDAP presents a powerful, growth-driven opportunity that continues to strengthen with every quarter.
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