Ultrasound Technology Aims to Replace Invasive BPH Procedures

With prevalence expected to rise as populations age, clinicians continue to seek less invasive, image‑guided options to relieve obstruction and symptoms. A new image‑guided focused ultrasound system is now under clinical evaluation, with first patients treated in a feasibility trial assessing non‑invasive destruction of prostatic tissue.

HistoSonics’ Edison Histotripsy System has been used to treat the first patients in WOLVERINE, a prospective feasibility study evaluating the technology for symptomatic benign prostatic hyperplasia (BPH). The initial procedures were performed at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The study marks the first clinical use of the platform for BPH.

The Edison system delivers histotripsy, a non‑thermal, mechanical form of focused ultrasound that uses the mechanical properties of acoustic energy to destroy targeted tissue under real‑time image guidance. The approach is non‑invasive and does not require incisions or endoluminal instrumentation, with the potential for fewer side effects than traditional, invasive BPH therapies. The platform is designed to ablate unwanted tissue while preserving surrounding structures through precise energy delivery.

Regulatory status for the platform remains indication‑specific. The Edison Histotripsy System is currently cleared in the United States for the destruction of liver tumors. Its use for BPH is limited to investigational settings. WOLVERINE is a prospective, multi‑center, single‑arm feasibility trial designed to evaluate safety in up to 20 patients. Post‑procedure imaging within 72 hours will assess immediate treatment effects, and participants will be followed longitudinally to further evaluate safety and procedural outcomes.

BPH is among the most common urologic conditions in men, with approximately 50% of men over 50 and up to 80% over 80 experiencing associated symptoms. Globally, more than 110 million men are affected, underscoring the need for effective, less invasive treatments.

“BPH affects millions of men worldwide and most of the existing treatment options require invasive procedures or lengthy recovery times,” said Mike Blue, Chairman and CEO, HistoSonics. “We believe histotripsy’s ability to mechanically destroy targeted tissue, completely non‑invasively, has the potential to transform how BPH is treated. In addition, this milestone represents significant progress in our pursuit to expand the unique benefits of histotripsy over a significant number of serious clinical conditions throughout the body.”

“We are excited and extremely proud that Prince of Wales Hospital is the first center in the world to offer this novel treatment approach in a clinical trial and potentially benefit patients with BPH in the future,” said Dr. Peter Chiu, study investigator and Associate Professor of The Chinese University of Hong Kong. “If shown to be safe and effective, the non‑invasive nature of histotripsy has the potential to change how BPH is treated for many patients suffering from lower urinary tract symptoms around the world.”

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