Focal One Robotic HIFU: Evolution and Expansion
Key Points
- EDAP TMS has transitioned its branding and public-facing identity to become Focal One, the name of both its flagship device and its operating brand.
- Focal One’s primary clinical application is prostate cancer, but the company has been expanding into several new clinical areas.
Over the past three years, EDAP TMS has transitioned its branding and public-facing identity to Focal One, which is the name of both its flagship device and its operating brand. While the legal name, EDAP TMS, remains unchanged due to its publicly traded status on the NASDAQ Index (EDAP), Focal One now represents the company’s broader mission and evolving technology platform.
Founded in 1979 and headquartered in Lyon, France, Focal One specializes in high-intensity focused ultrasound (HIFU), which it initially developed for the management of prostate cancer. From receiving CE Marking for its first HIFU platform to the US Food and Drug Administration (FDA) clearance of the Focal One device in 2018, the company has become a leader in noninvasive ultrasound therapy, with a strong and growing global footprint. Beyond its headquarters in Lyon, Focal One maintains United States (U)S offices in Austin, Texas, and Los Altos, California, with additional subsidiaries in Germany, Switzerland, Korea, Japan, and Malaysia.
Leadership and Team
Ryan Rhodes now leads the company as CEO, bringing more than 30 years of experience in medical devices. He was instrumental in the successful launch of the global urology franchise at Intuitive Surgical and now heads the leadership team at Focal One with deep expertise in healthcare innovation.
Focal One employs around 300 people, with approximately 25% of them based in the US—the company’s fastest-growing market.
Expanding Beyond Men’s Health
Though Focal One’s original focus was prostate cancer, the company has been expanding into new clinical areas, including:
Endometriosis
The company has received CE Marking in Europe and FDA Breakthrough Device Designation for the treatment of deep infiltrating rectal endometriosis. Focal One also recently completed a Phase 3 double-blind, randomized controlled trial for the condition. Encouragingly, 85% of trial participants in the control group chose HIFU treatment after unblinding. The investigators are currently preparing to publish the full results.
Pancreatic Cancer
A new Phase I/II clinical trial (called “PULS”) has been launched in France to evaluate HIFU for the treatment of pancreatic tumors. The system uses a unique HIFU technology that has been designed to target tumors that are inoperable due to their location in the pancreas and/or their proximity to critical structures (like arteries). This work aligns with Focal One’s broader goal of applying HIFU technology to a wider range of solid organ tumors.
Benign Prostatic Hyperplasia (BPH)
A combined Phase I/II, multicentric, clinical trial is currently underway in France to evaluate optimized HIFU protocols for the treatment of BPH. In the US, Focal One’s FDA clearance is for ablation of prostate tissue, which could apply to both prostate cancer and BPH. In Europe, the CE marking is specific only to prostate cancer. While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. This clinical approach in addressing BPH represents a logical next step in expanding Focal One’s Robotic HIFU technology beyond the application in prostate cancer.
Products and Innovation
Focal One
The primary system in use today, the Focal One, was FDA-cleared in 2018. It was the first device dedicated specifically to focal therapy in the management of prostate cancer, and it now has numerous global regulatory approvals.
Focal One i
The latest evolution of the Focal One i platform, Focal One i, was launched in 2025, and has several new feature highlights.
It brings expanded HIFUsion® capabilities to enhance prostate cancer treatment planning through the integration of advanced diagnostic imaging and biopsy mapping with real-time ultrasound. Built as an open-platform solution, HIFUsion supports the latest Digital Imaging and Communications in Medicine (or “DICOM”) standards and incorporates artificial intelligence (AI)-driven algorithms for intelligent, data-informed treatment planning. Additionally, Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) integration enables the fusion of PSMA PET scans with Focal One’s best-in-class live ultrasound. This cutting-edge feature allows for more personalized and accurate treatment plans, leveraging the latest in diagnostic imaging to optimize outcomes. The Focal One i also offers a streamlined, step-by-step guided workflow that improves fusion accuracy, reduces distortion, and ensures consistency across treatments. The result is greater surgeon confidence and enhanced efficiency in the operating room. An embedded video content library has been added to provide in-system video content that supports real-time learning, giving users access to procedural refreshers and best practices on demand. The system’s new treatment streaming and recording* feature also enhances education and collaboration through remote proctoring and peer-to-peer support. It allows collaboration with peers worldwide, expanding patient access regardless of location. Lastly, Focal One i is designed to support additional clinical indications, including endometriosis.* As mentioned above, Focal One’s robotic HIFU system received CE Mark certification in March 2025 for the treatment of posterior deep endometriosis infiltrating the rectum and surrounding structures.
*Not available in all markets. May require additional purchase.
Clinical Research
Focal One’s ongoing collection of clinical data continues to position HIFU as a compelling alternative to traditional surgical treatment for localized prostate cancer.
HIFI Study
This landmark prospective study enrolled more than 3,000 participants and compared HIFU to surgery for localized prostate cancer. The results, which were published in European Urology, showed comparable cancer control to radical prostatectomy with significantly better functional outcomes in terms of urinary continence and sexual function.
FARP Study
The Focal Ablation versus Radical Prostatectomy (FARP) study was a randomized controlled trial comparing HIFU focal ablation with robotic prostatectomy surgery. The final results were recently presented at the American Urological Association’s 2025 meeting. The FARP findings reinforced those from the HIFI study, which was that HIFU provides noninferior oncologic control while preserving better continence, erectile function, and quality of life. A peer-reviewed publication is expected in the coming months.
Market Expansion and Global Presence
Focal One has seen rapid worldwide adoption, particularly in the US, Europe, the Middle East, Asia, and Latin America.
As of June 2025, more than 73 Focal One systems have been installed in the US. In Europe, more than 300 clinical sites now offer the Focal One procedure. The company has also been actively expanding across Taiwan, Korea, Malaysia, Brazil, Chile, Panama, the United Arab Emirates, and Saudi Arabia.
A Breakthrough in Telemedicine
In April 2025, Focal One i enabled the world’s first remote transatlantic robotic HIFU procedure for prostate cancer, when it connected a Cleveland Clinic team in the US with treating physicians in Abu Dhabi, United Arab Emirates (UAE). The Cleveland Clinic–based physician remotely mapped and supervised a prostate cancer procedure that was being performed on patient by a local team in the UAE—a major step forward in remote surgical collaboration.
Supporting Physicians and Partners
Focal One collaborates with manufacturers that develop the ultrasound transducers and scanners that are integrated into its systems. Another key collaborator is LabTAU in France for foundational research and clinical trial development. The company also supports physicians who are interested in establishing HIFU centers by offering clinical, regulatory, and operational guidance.
Overcoming Challenges
Focal One has navigated the complex path of medical device innovation – from research and development to clinical trials, regulatory approvals, and market access. One of the company’s biggest ongoing challenges is reimbursement, which is essential for widespread adoption. In 2021, Focal One achieved a major milestone by securing a CPT Category I code, which led to nationwide Medicare coverage. Work continues to expand reimbursement to commercial insurers.
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