Focal One® - Physicians Clinical Information

Non-Invasive Prostate Tissue Ablation

Prostate Tissue Ablation with HIFU has been used and studied around the world for more than 20 years. Today, more than 100 peer-reviewed publications constitute a solid body of evidence for HIFU prostate ablation in the management of Prostate Cancer.

Low Incontinence, Low Erectile Dysfunction, High Cancer Control

Chief Executive Officer 
Ryan Rhodes

The ablation of prostate tissue with HIFU has shown reproducible results in treating clinically significant cancer and avoiding progression to radical treatment while maintaining high urinary continence and sexual function.  

FocalOne® | Clinical Information​

2023 – Minerva Urology and Nephrology

MRI/real-time ultrasound image fusion guided high-intensity focused ultrasound: a prospective comparative and functional analysis of different ablative techniques

S. De Luca, et al.

“Our study suggests that patients’ specific HIFU tailoring with the MRI/real-time TRUS Guidance by Focal One® device is able to minimize the side effects of treatment.”

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2021 – Prostate Cancer and Prostatic Diseases

Oncological and functional outcome after partial prostate HIFU ablation with Focal-One : a prospective single-center study

M. Dellabella, et al.

“189 prospectively enrolled prostate cancer patients underwent focal ablation with Focal One Robotic. “Index lesion HIFU ablation demonstrated satisfactory early oncological outcome […]. Urinary function was well preserved.”

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2018 – Journal of EndoUrology

Focal Treatment for Unilateral Prostate Cancer Using High-Intensity Focal Ultrasound: A Comprehensive Study of Pooled Data

S. Albisinni, et al.

“In the 366 analyzed cases, […] at one year after HIFU, negative biopsy rate for clinically significant PCa was 87% (79–96), whereas salvage treatment-free survival rate was 92% (85–98). Regarding functional outcomes, reported potency rates were 74% (64–84), and continence 96% (91–100)…”

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 2020 – Journal of Urology

High Intensity Focused Ultrasound Hemigland Ablation for Prostate Cancer: Initial Outcomes of a United States Series

A. Abreu, et al.

“Short-term results of focal high intensity focused ultrasound indicate safety, excellent potency and continence preservation, and adequate short-term prostate cancer control. Radical treatment was avoided in 91% of men at 2 years”

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2017 – British Journal of Urology International

Salvage high-intensity focused ultrasound (HIFU) for locally recurrent prostate cancer after failed radiation therapy: Multi-institutional analysis of 418 patients

S. Crouzet, et al.

Retrospective study of 418 patients with local recurrent disease after EBRT treated with Salvage HIFU in 9 different centers in Europe. “The OS, CSS and MFS rates at 7 years were 72%, 82% and 81%, respectively.”

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2017 – Journal of EndoUrology

Comparing High-Intensity Focal Ultrasound Hemiablation to Robotic Radical Prostatectomy in the Management of Unilateral Prostate Cancer: A Matched-Pair Analysis

S. Albisinni, et al.

“In this matched pair analysis, HIFU hemiablation was comparable to RALP in controlling localized unilateral PCa, with no significant differences in the need for salvage therapies. HIFU was also associated to significantly better functional outcomes.”

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2016 – European Urology

Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients 

P. Rischmann, et al.

“At 1 yr, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 yr.”

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2015 – Prostate Cancer and Prostatic Diseases

A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer

R. van Velthoven, et al.

“Hemiablation HIFU therapy, delivered with intention to treat, for carefully selected patients affords mid-term promising functional and oncological outcomes.”

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2015 – European Urology

Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes

E. Cordeiro, et al.

“This study showed that high-intensity focused ultrasound hemiablation in selected patients with unilateral organ-confined prostate cancer can be used for satisfactory cancer control with minimal effect on genitourinary functions.”

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2014 – British Journal of Urology

Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study

E. Baco, et al.

“Hemi-Salvage HIFU is a feasible therapeutic option in patients with unilateral radiorecurrent prostate cancer, which offers limited urinary and rectal morbidity, and preserves health-related quality of life.”

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2013 – Journal of Urology

Evolution and Outcomes of 3 MHz High Intensity Focused Ultrasound Therapy for Localized Prostate Cancer During 15 Years

S. Thüroff, et al.

“Of 704 study patients 78.5% had intermediate or high risk disease. Mean followup was 5.3 years (range 1.3 to 14). Cancer specific survival was 99%, metastasis-free survival was 95%, and 10-year salvage treatment-free rates were 98% in low risk, 72% in intermediate risk and 68% in high risk patients.”

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2013 – British Journal of Urology

Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer

R. Ganzer, et al.

“The study demonstrates the efficacy and safety of HIFU for localized PCa. HIFU is a therapeutic option for patients of advanced age, in the low- or intermediate-risk groups, and with a life expectancy of ~10 years.”

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2013 – European Urology

Whole-gland Ablation of Localized Prostate Cancer with High-intensity Focused Ultrasound: Oncologic Outcomes and Morbidity in 1002 Patients

S. Crouzet, et al.

“HIFU is a potentially effective treatment of localized PCa, with a low PCa-specific mortality rate and a high MFSR at 10 yr as well as acceptable morbidity.”

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2021 – European Urology Focus

Oncological Long-term Outcome After Whole-gland High-intensity Focused Ultrasound for Prostate Cancer—21-yr Follow-up

J. Bründl, et al.

“Long-term data after whole-gland high-intensity focused ultrasound (HIFU) therapy are crucial to prove its oncological efficacy, and may help derive implications for focal treatment strategies and patient selection. In this context, whole-gland HIFU achieved good long-term cancer control up to 21 yr in low- and intermediate-risk prostate cancer (PCa) patients.”

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Focal One Advantages


Why Physicians Benefit from a HIFU Program

Why Physicians are Adding Focal One to their Prostate Cancer Management Programs and how Focal HIFU  Therapy fills an important gap in Prostate Cancer management programs. Visit the Physician section to review 154 peer-reviewed publications regarding Focal HIFU Therapy.

Prostate Treatment

How Patients Benefit from HIFU

Discover the Patient Benefits of HIFU and how you can change your prostate health without changing your life. Focal One HIFU Prostate Tissue Ablation allow patients maintain their quality of life with minimal side-effects. To find a HIFU Center near you, visit the Patient section.


AUA and Focal One - the Leading Prostate Focal Therapy Controlled by Urologists.

The 2024 AUA Annual Meeting is here. Experience the Leading Prostate Focal Therapy Controlled by Urologists. Join Focal One as Urologists from around the globe attend the 2024 AUA Annual Meeting in San Antonio, Texas.