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Sonablate Corp. announces publication of clinical data supporting the use of Sonablate HIFU

CHARLOTTE, NC, USA, February 7, 2022 / Sonablate Corp., a world leader in minimally invasive focused ultrasound technologies, today announced the publication of data that supports the use of Sonablate® High Intensity Focused Ultrasound (HIFU) for focal prostate ablation and shows favorable disease control in the medium-term.

The article titled “Cancer Control Outcomes Following Focal Therapy Using High-Intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer: A Multi-institute 15-year Experience” authored by Deepika Reddy, MD (first author), Prof. Hashim Ahmed and Prof. Mark Emberton (joint senior authors), was published in European Urology. This study analyzed 1379 patients with ≥6 months of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centers, which is the largest reported cohort of focal HIFU. The Sonablate device was the sole HIFU device used for treatments.

A total of 1379 patients were evaluated with the median age being 66 years old and prostate-specific antigen was 6.9. Of the patients enrolled, 65% were classified with intermediate-risk prostate cancer and 28% were high-risk. The overall median follow-up was 32 months and for those with ≥5 years of follow-up, it was 82 months.

Key findings from the study include:

  • Metastasis-free survival and prostate cancer-specific mortality at 7 years were 100%
  • 7-year Failure-free survival (FFS) in intermediate- and high-risk cancers was 68% and 65%. FFS at 7 years for patients with at least 5-yr follow-up was 74% (69–80%), with no statistically significant difference demonstrated between intermediate- and high-risk disease.
  • Adverse events** occurred in 0.5% patients

The study limitation included a lack of follow-up data at 10-years.

“This data further supports the power of focal therapy using Sonablate HIFU as an alternative to treating the whole prostate. Carefully selected patients can maintain disease control in the medium-term with minimal side effects.” Says Karen Cornett, VP, Clinical Operations at Sonablate Corp.

“We know that after focal HIFU, men recover quickly and have fewer side effects. We now have excellent long-term cancer control data from the largest and longest study of focal HIFU treatment. We can be confident that HIFU is an effective treatment for prostate cancer that should be offered routinely to men with clinically significant prostate cancer.” Said Professor Hashim Ahmed+, senior author of the study and urologist from the Department of Surgery and Cancer at Imperial College of London.

* Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer-specific mortality.
** Adverse events were reported using Clavien-Dindo classification.
+ Dr. Hashim Ahmed is a paid consultant for Sonablate Corp. but was not compensated for this study. Sonablate Corp. provided funding for the HEAT Registry, but not the compilation of this study.

About Sonablate Corp.
Sonablate Corp. is a world leader in minimally invasive focused ultrasound technologies. Sonablate Corp. is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. Sonablate Corp., with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the Sonablate®, which has 510(K) clearance in the U.S and NMPA clearance in China; and Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 50 countries outside the U.S. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For additional information, visit

Media Contact:
Sonablate Corp.
Nicole Hill