CHARLOTTE, N.C., May 14, 2026 (GLOBE NEWSWIRE) -- Sonablate, a global leader in High-Intensity Focused Ultrasound (HIFU) technology, today announced the launch of the SONA FUSION Registry (Sonablate Focused Ultrasound Study for Integrated Outcomes Network), a first-of-its-kind global outcomes initiative designed to unify international real-world evidence collection across prostate cancer and benign prostatic hyperplasia (BPH) treatment using Sonablate HIFU, helping advance clinical understanding, physician collaboration, and future standards in focal therapy. The initiative aims to address one of the most significant barriers to broader adoption of focal therapy: the lack of large-scale, standardized long-term outcomes data across diverse patient populations and clinical settings.
As prostate care continues to evolve toward more personalized and function-preserving approaches, Sonablate defines Precision Sound Medicine™ as the use of targeted, image-guided ultrasound energy to treat disease while preserving function and patient quality of life. It reflects an evolving shift in prostate care, from treating disease alone to achieving the optimal balance between cancer control, function preservation, and individualized care.
The registry launch comes ahead of Sonablate’s presence at American Urological Association’s Annual Meeting (AUA2026), a pivotal moment for prostate care. As the field increasingly explores incision-free, function-preserving approaches, the need for robust, longitudinal, real-world evidence has become a defining challenge for broader clinical adoption and guideline integration. With decades of experience in focused ultrasound innovation and a growing global network of physicians and academic collaborators, Sonablate remains uniquely positioned as the only focal therapy platform with extensive clinical experience and FDA clinical trial programs spanning both prostate cancer and BPH.
The SONA FUSION Registry is expected to have more than 5,000 patients from over 15 participating sites and more than five countries for the next decade. Anchored initially at Indiana University under the leadership of Principal Investigator Dr. Clint Bahler, the registry is designed to become one of the most comprehensive coordinated global HIFU focal therapy datasets.
“The data Sonablate will gather is critical for prostate cancer and BPH patient outcomes, and for the entire field of urology,” said Dr. Bahler. “The field has lacked a coordinated, large-scale real-world evidence platform capable of evaluating outcomes across institutions and diverse patient populations. The SONA FUSION Registry is designed to help address that gap and generate meaningful insights that can inform future research, and the continued evolution of focal therapy.”
Additional participating academic and clinical centers across the United States, Europe, and Asia are expected to join the initiative throughout 2026 as Sonablate expands the registry’s global network of collaborators and centers of excellence.
The registry will collect long-term, real-world outcomes data related to cancer control, urinary continence, sexual function, retreatment rates, complications, and patient-reported quality-of-life. It will also support the development of more consistent benchmarks for focal therapy, inform patient selection and treatment approaches, and contribute to the evolving evidence base considered in clinical practice and guidelines globally.
The initiative reflects a broader industry shift toward evidence-driven, function-preserving prostate care and greater collaboration across academic institutions, physicians, and healthcare systems worldwide. As demand grows for alternatives to surgery, radiation, and prolonged active surveillance, the registry is designed to address one of the most significant gaps in modern prostate cancer: the need for long-term, multi-center outcomes data demonstrating how focal therapy performs in real-world clinical practice.
“The future leaders in medtech will be the organizations capable of pairing innovative technology with scalable evidence generation,” said Brad Saar, Sonablate board member and former president of Stryker’s Medical Division. “What Sonablate is building through the SONA FUSION Registry has the potential to accelerate how focal therapy is understood, evaluated, and integrated into mainstream prostate care globally.”
Unlike traditional clinical trials limited by strict protocols and narrow patient populations, the SONA FUSION Registry will capture data across diverse healthcare systems, physician approaches, and patient profiles to help identify best practices in patient selection and procedural optimization.
The registry will evaluate outcomes for patients treated with Sonablate HIFU for both prostate cancer and BPH, making it one of the first global initiatives to examine oncologic control and functional preservation across both diseases within a single coordinated ecosystem. Initial analyses from the registry are expected to begin in late 2026, with ongoing interim reviews planned every six months to support future scientific presentations and publications.
“Prostate care is at an inflection point, where the conversation is shifting from simply treating disease to treating patients more precisely and with greater consideration for long-term quality of life and function,” said Richard Yang, CEO of Sonablate. “However, for focal therapy to realize its full potential within mainstream care, the field must continue to build a more unified and durable clinical intelligence platform. With the launch of the SONA FUSION Registry, we are building the global evidence infrastructure needed to advance focal therapy from an emerging approach to a standardized part of mainstream care. Technology initiates adoption, but evidence ultimately defines standards of care.
Sonablate representatives will be available during AUA2026 at booth 826 to share more information about the launch of the registry.
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
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/64db807c-9ef4-4759-950c-34c3ef3d84a2
