Landmark 10-Year Study Strengthens Long-Term Evidence Supporting Focal Therapy

Independent research from a UK group demonstrates durable long-term tissue ablation, while Sonablate’s extensive clinical use reflects its role in advancing HIFU technology worldwide

CHARLOTTE, N.C., July 27, 2026 (GLOBE NEWSWIRE) -- Sonablate Corp., a medical technology company focused on non-invasive prostate tissue ablation using high-intensity focused ultrasound (HIFU), today acknowledged new long-term data supporting focal therapy for localized prostate disease while highlighting more than 20 years of global experience in advancing HIFU technology.

Published in European Urology, one of the field’s leading peer-reviewed journals, the study represents one of the largest and longest follow-up analyses of focal therapy reported to date. The findings reflect continued clinical interest in treatment approaches that aim to balance oncologic control with preservation of urinary and sexual function.

Key Findings from the Study

The independent study followed 3,477 patients treated between 2004 and 2024 through the United Kingdom’s prospective HEAT and ICE registries, with results revealing:

Clinical Outcomes

• Approximately 83% treated with focal HIFU
• Approximately 0.1% prostate cancer-specific mortality at 10 years
• Approximately 3% metastatic progression at 10 years
   

Significance

• One of the largest prospective registries evaluating focal therapy
• 10-year follow-up in a real-world clinical setting
• The authors reported in the news, oncologic outcomes comparable to published results for surgery and radiation in similar-risk populations
• A 10-year local retreatment rate of 33%, with a post-hoc analysis demonstrating an 8.9% rate of conversion to radical treatment for patients adhering to a protocol of up to two focal ablation sessions.
   

These findings contribute to a growing body of evidence supporting focal therapy as a treatment option for appropriately selected patients. Importantly, the results also reflect the work of independent investigators and add to ongoing efforts across the field to better understand long-term outcomes associated with focal approaches.

A Milestone for the Focal Therapy Community

“This publication represents an important milestone for the field, reflecting long-term follow-up and continued evaluation of focal therapy approaches in prostate cancer,” said Professor Naren Sanghvi, Chief Science Officer of Sonablate Corp. and founder of Sonablate® HIFU technology. “As clinicians continue to explore treatment strategies that aim to preserve quality of life while effectively managing disease, studies of this scale and duration contribute meaningful insight into how focal therapy may be incorporated into evolving care pathways.”

Sonablate also recognized the contributions of the study’s investigators, including Professor Hashim Ahmed, Professor Mark Emberton, Dr. Alexander Light, and Dr. Taimur Shah, along with the physicians, clinical teams, and patients whose participation supported the long-term data collection.

Advancing Real-World Evidence in Focal Therapy

Independent registry efforts, such as HEAT and ICE, contribute to a growing body of real-world evidence evaluating focal therapy in clinical practice. In parallel, Sonablate continues to support data generation through its own clinical registry initiatives, reflecting an ongoing commitment to transparency and long-term outcomes evaluation.

Localized prostate cancer often progresses over many years, underscoring the importance of extended follow-up when assessing treatment approaches. While randomized controlled trials provide important early insights, longer-term real-world data can help inform understanding of durability, safety, and functional outcomes across broader patient populations.

Together, these complementary forms of evidence contribute to a more complete view of how focal therapy may be applied in clinical practice.

More Than Two Decades of Clinical Development in HIFU

For more than 20 years, Sonablate has worked alongside physicians and academic institutions globally to support the development and adoption of HIFU for prostate tissue ablation. Through collaboration on clinical research, physician education and treatment protocols, the company has contributed to the advancement of focal therapy approaches and the generation of long-term outcomes data.

In 2015, Sonablate became the first HIFU system cleared by the U.S. Food and Drug Administration (FDA) for the ablation of prostate tissue. Today, Sonablate HIFU technology has been used to treat more than 100,000 patients worldwide and has received regulatory approvals in more than 50 countries.

Continuing to Advance Focused Ultrasound

Sonablate continues to collaborate with physicians, academic centers, and research partners to support ongoing clinical research, physician education, and technology development in focused ultrasound. Areas of focus include patient selection, treatment planning, real-time monitoring, and long-term outcomes evaluation, including advancements such as SONA FUSION.

As interest in non-invasive, outpatient approaches to prostate care continues to grow, the company remains focused on supporting the responsible adoption of focal therapy through evidence generation and clinical collaboration.

About Sonablate Corp.

Sonablate Corp. is a global leader in non-invasive, focused ultrasound technologies and a pioneer in precision sound medicine. The company’s Sonablate® HIFU system is FDA-cleared in the United States for prostate tissue ablation and has received regulatory approvals in more than 50 countries worldwide.

Media Contact:
Mannon Lindhorst
sonablate@mww.com