Focal One México:
Robotic Innovation in Precision Urology
Leaders in Robotic Urology and Precision Care
Innovative Technology for Better Health
Focal One Mexico is made up of a team of medical specialists dedicated to advancing men's health through cutting-edge medical care. We are committed to bringing scientific innovation to northwestern Mexico and have established ourselves as pioneers in the region by introducing the first Focal One robotic system in northwestern Mexico, marking a historic milestone in the practice of medicine across the states of Sonora and Baja California.
Our medical practice, located in San Luis Rio Colorado, Sonora, is supported by the expertise, clinical judgment, and board certification of four leading urologists who are highly trained in the use of this state-of-the-art robotic technology.
Dr. Wolfgang Willem L.
Graduated from the Autonomous University of Nuevo Leon, Dr. Willem is a board-certified urologist with more than 33 years of experience and a long-standing commitment to innovation in advanced urologic technology. He is a member of the Mexican College of Urology and the Mexican Society of Urology, as well as a founding member of urological associations in Baja California, San Luis Rio Colorado, and Sonora. He currently serves as Director of Clínica San Agustín, a medical center specializing in advanced urologic procedures.
Dr. Iván Robles
Board-certified urologist and graduate of the Autonomous University of Nuevo Leon (UANL), with advanced fellowship training in Minimally Invasive and Robotic Surgery. He is an active member of Mexico's National System of Researchers (SNII), under the Ministry of Science, Humanities, Technology and Innovation (SECIHTI). He also serves as Co-Editor of the Mexican Journal of Urology (RMU), is the author of more than 35 peer-reviewed scientific publications, and has received multiple national and international awards and recognitions for his contributions to clinical research.
Dr. Gilberto Paz
Board-certified urologist and graduate of the University of Guadalajara. He is a member of several national and international urological associations and serves as a Professor of Clinical and Theoretical Urology at the Autonomous University of Baja California (UABC), Mexicali campus.
Dr. Paz is a pioneer in the use of botulinum neurotoxins for the treatment of male sexual dysfunction and is currently developing a patented therapeutic approach in this field. He has extensive experience in clinical research protocols and is recognized for his pioneering work in the management of urethral complications associated with radical prostate cancer treatments. His broad institutional experience spans clinical practice, research, and academic medicine.
Dr. Juan Sierra
Board-certified urologist and graduate of the Autonomous University of Guadalajara. He is a member of several national and international urological associations and a pioneer in Functional Urology (Urodynamics) in northwestern Mexico.
Dr. Sierra is an investigator in prostate cancer clinical research protocols and has performed more than 500 ultrasound-guided prostate biopsies, making him one of the region's most experienced specialists in this procedure. He has advanced training in the implantation of penile prostheses and previously served as a Professor of Medicine at Universidad Xochicalco, Mexicali campus. He also brings extensive experience in institutional healthcare and academic medicine.
The minimally invasive High-Intensity Focused Ultrasound (HIFU) solution for localized prostate adenocarcinoma. Bring the gold standard in automated focal therapy to your patients across Northwestern Mexico.
FOCAL THERAPY ADDRESSES A CRITICAL UNMET NEED IN THE TREATMENT OF PROSTATE CANCER
Focal One® and HIFUsion™ software seamlessly integrates advanced diagnostic imaging with real-time ultrasound biopsy mapping, enabling highly precise treatment planning. With the advanced capabilities of HIFUsion™, urologists can accurately define the treatment target while preserving surrounding critical structures. Built on an open-platform architecture, HIFUsion™ supports the latest DICOM standard, enhances compatibility with patient-specific imaging, and leverages AI-powered algorithms for optimized treatment planning.
Advantages of the Dynamic Approach
Key Advantages of Focal One HIFU Technology
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Electronic Focal Point Steering: Enables precise, non-invasive destruction of the targeted prostatic tissue while preserving the surrounding healthy structures.
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Treatment of Larger Prostates: Proven efficacy in treating the anterior portion of large prostates, with an anteroposterior (A–P) distance of up to 40 mm.
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Homogeneous Ablation with Real-Time Temperature Control: Delivers uniform tissue ablation while reducing treatment time for larger treatment volumes.
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Personalized Treatment Options: Compatible with focal lesions, hemi-gland, or whole-gland treatment, providing the flexibility to tailor therapy to each patient's specific clinical needs.
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Conformal Treatment: Enables tissue ablation that conforms to the shape of the targeted tumor while preserving adjacent critical structures, minimizing the risk of damage and improving outcomes in partial gland ablation.
The Key Pillars of the Focal One Platform
Robotic Positioning System
The Focal One® robotic positioning system provides submillimeter precision with five degrees of freedom, ensuring accurate targeting while incorporating automated safety features.
Open-Platform Fusion Software
HIFUsion® enables the urologist to import, visualize, and fuse multiparametric MRI with 3D biopsy maps during treatment. This enhances treatment accuracy by precisely defining and targeting lesions while preserving surrounding critical structures.
Integrated Workstation
The cart-mounted Focal One® system is designed to provide seamless compatibility with standard operating room tables, allowing easy integration into virtually any clinical workflow.
Dynamic Focusing Probe
The dynamic focusing probe combines high-resolution, real-time ultrasound imaging with precise HIFU energy delivery, resulting in greater treatment accuracy and shorter procedure times.
Dynamic Focusing Probe Technology
The patented dynamic focusing probe delivers high-resolution, real-time ultrasound imaging throughout the procedure using the most advanced imaging transducer available in any HIFU platform. It enables precise HIFU energy delivery at treatment depths from 5 mm to 40 mm, in 5-mm increments along the anteroposterior (A–P) axis, expanding the treatment range beyond that of conventional transrectal HIFU systems.
No Surgery.
No Incisions.
No Radiation.
The Focal One robotic HIFU system harnesses high-performance High-Intensity Focused Ultrasound (HIFU) technology to accurately target and ablate prostate tissue while preserving surrounding healthy structures and minimizing treatment-related side effects. This non-invasive approach reduces the risk of complications commonly associated with conventional treatment options.
The Most Advanced Prostate Treatment Available Today
Focal One Robotic HIFU is trusted by leading urologists worldwide and supports more than 4,000 procedures each year.
50,000+
Treatments Performed Worldwide
100+
Peer-Reviewed Publications
300+
HIFU Centers Worldwide
Advantages of the Focal One® Robotic Positioning System
Five Degrees of Freedom offers unrestricted movement across five degrees of freedom (three linear and two rotational axes), allowing both manual and motorized positioning.
Automated Probe Positioning ensures optimal probe placement while protecting the rectal wall throughout HIFU energy delivery for enhanced treatment precision.
Robotic Execution of the Treatment Plan accurately executes the planned ablation with exceptional precision, delivering safe, effective, and highly reproducible clinical outcomes.
Evidence from large clinical studies has shown that robotic HIFU provides favorable oncologic outcomes while preserving urinary continence and sexual function in many patients.
The Principle of HIFU
High-Intensity Focused Ultrasound (HIFU) focuses ultrasound energy at a precise target to deliver high-intensity acoustic waves. The concentrated ultrasonic energy rapidly elevates the temperature at the focal point, inducing coagulative necrosis while sparing surrounding healthy tissue and adjacent structures outside the treatment zone.
Comparing Focal One Robotic HIFU
with Other Treatment Options
Focal One Robotic HIFU enables precise ablation of targeted prostatic tissue while minimizing exposure of adjacent critical structures. Clinical studies have demonstrated preservation of urinary continence and sexual function following treatment.
The Prospective Non-inferiority Comparative Clinical Trial of Prostate Cancer Treatments
ClinicalTrials.org NCT#04307056 | Sponsored by AFU
HIFU vs Radical Prostatectomy For the Treatment of Prostate Cancer
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HIFI is the largest prospective comparative multi-center clinical study ever conducted evaluating oncologic and functional outcomes of localized prostate cancer treatments
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3,328 prospective patients enrolled, including 1,967 consecutive HIFU patients and 1,361 Radical Prostatectomy (RP) patients across 46 centers.
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Study met both primary endpoint (non-inferior salvage treatment-free survival at 30 months) and secondary endpoint (favorable functional outcomes at 12 months)
Comparable Oncologic Outcomes
Non-Inferior Salvage Treatment-Free Survival Rate
at 30 months (Primary Endpoint)
Prostate Cancer Control
Salvage Treatment is defined by the use of any salvage treatments such as Radical Prostatectomy (RP), Radiation Therapy (RT) and/or Androgen Deprivation Therapy (ADT) due to cancer progression.
Superior Functional Outcomes
Favorable Urinary Continence and Erectile Function Preservation
at 12 months (Secondary Endpoint)
“This nationwide trial is the first to prospectively comparing HIFU and surgery for the treatment of localized prostate cancer. The results demonstrate that medium-term salvage treatment-free outcomes are comparable with a better safety profile favoring HIFU.” – HIFI Study Authors
Prospective Study Design
3,328 patients: The Largest Prospective Comparative Study in Prostate Cancer Treatment
PATIENT INCLUSION CRITERIA
The patient inclusion criteria was defined following the 2014 recommendations from the National Prostate Cancer Committee:
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Localized, low- to intermediate risk PCa
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Clinical Stage T1-2 NxM0
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Prostate Specific Antigen (PSA) dosage < 15 ng/mL
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Gleason score ≤ 3 + 4 (Grade Group 1 or 2)
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Not eligible for active surveillance (AS)
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Maximum of 4 invaded sextants out of 6 on biopsies performed following multiparametric MRI (mpMRI)
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HIFU was restricted to patients over 69 years old with at least a 5-year life expectancy
“The primary endpoint, 30-month STFS adjusted on the variable used to propensity score construction, was in the HIFU group 90% versus RP group 86%. Non-inferiority analysis showed that HIFU had a lower risk of ST compared to RP (HR=0.71[ 95%CI, 0.52-0.97], p=0.008). This result remains when focusing on GG2 (HR=0.66[ 95%CI, 0.50-165 0.86], p=0.001).”
– HIFI Study Authors
Patient Cancer Characteristics
Baseline disease characteristics are balanced between the two groups
HIFI Study Conclusion
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The HIFI Study Successfully met the primary endpoint of non-inferior Salvage Treatment-free
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Survival (STFS) after HIFU compared to Radical Prostatectomy (RP) at 30 months:
Patients treated with HIFU had a significantly higher adjusted STFS at
30 months of 90% versus 86% STFS in patients who underwent RP. -
Functional outcomes demonstrated better results with respect to urinary continence and erectile function in patients receiving HIFU therapy versus patients receiving RP.