Sonablate highlights 10-year HIFU focal therapy data from 3,477 patients

Sonablate Corp. has drawn attention to a large independent study published in European Urology showing durable oncologic outcomes for focal high-intensity focused ultrasound (HIFU) in localised prostate cancer, with a 10-year follow-up across nearly 3,500 patients treated at UK centres.

The study, which the company acknowledged rather than sponsored, drew on the prospective HEAT and ICE registries and followed 3,477 patients treated between 2004 and 2024. Reported outcomes included a prostate cancer-specific mortality rate of approximately 0.1% at 10 years and a metastatic progression rate of approximately 3% over the same period. The study's authors noted these figures were comparable to published results for surgery and radiation in similar-risk populations, though direct head-to-head comparisons were not part of the registry design.

Around 83% of the cohort received focal HIFU as their primary treatment. The 10-year local retreatment rate was 33%, a figure that reflects the organ-sparing nature of focal approaches, where repeat ablation is often planned. A post-hoc analysis found that patients adhering to a protocol of up to two focal ablation sessions showed an 8.9% rate of conversion to radical treatment, a number clinicians will weigh when counselling patients on the trade-offs between preservation of function and longer-term disease control.

Clinical significance

Professor Naren Sanghvi, Chief Science Officer at Sonablate and founder of the Sonablate HIFU platform, said the publication "represents an important milestone for the field, reflecting long-term follow-up and continued evaluation of focal therapy approaches in prostate cancer." The investigators named in the study include Professor Hashim Ahmed and Professor Mark Emberton, both prominent figures in the UK focal therapy research community.

For prostate cancer, where the slow pace of disease progression makes decade-long follow-up essential for meaningful conclusions, registry data of this scale carry considerable weight. Randomised controlled trials comparing focal therapy directly with radical prostatectomy or radiotherapy remain limited, which means real-world registry findings carry an outsized role in informing treatment guidelines and commissioning decisions.

Market and competitive context

Focal HIFU sits within a competitive landscape of minimally invasive prostate ablation technologies that also includes cryotherapy, irreversible electroporation, and focal laser ablation. Sonablate received FDA clearance in 2015 for prostate tissue ablation, positioning it as the first HIFU system to clear that regulatory threshold in the United States. The company says its technology has since been used in more than 100,000 patients and holds regulatory approvals in more than 50 countries.

The release also flags SONA FUSION, described as an area of ongoing development, though no clinical data or regulatory status for that platform was included in the announcement.

Interest in organ-sparing approaches to localised prostate cancer has grown as clinicians and patients seek to reduce the urinary and sexual function side effects associated with radical surgery and radiation. NICE in the UK has updated its guidance on focal therapy in recent years, and adoption continues to grow in specialist centres. The European Urology publication is likely to support both reimbursement arguments and physician education efforts, areas Sonablate identifies as central to its commercial strategy.