Trial launches of Edison Histotripsy System for benign prostatic hyperplasia

The first patients have been treated in the WOLVERINE study (NCT07214675), evaluating the Edison Histotripsy System for the management of symptomatic benign prostatic hyperplasia (BPH), HistoSonics announced.¹

Investigators in the prospective feasibility trial successfully treated the first patients at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong.

“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 study investigator Peter Chiu, MBChB (CUHK), FRCSEd (Urol), FCSHK, FHKAM (Surg), an associate professor of The Chinese University of Hong Kong, in a news release.¹ “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.”

WOLVERINE is a prospective, multi-center, single-arm feasibility study designed to enroll up to 20 men with symptomatic BPH. To be eligible for enrollment, patients need to be at least 50 years of age and have an International Prostate Symptom Score of 15 or higher, a prostate volume between 30 to 150 mL, and a Qmax of 15 mL/s or lower with a voided volume of at least 125 mL during a uroflow test.

All patients will undergo the histotripsy procedure, which includes “a non-thermal, mechanical process of focused ultrasound” to induce “mechanical destruction of prostate tissue”.² Following treatment, patients in the trial will undergo imaging within 72 hours to assess the immediate treatment effect. Longitudinal follow-up (conducted at 30 days, 90 days, and 180 days) will then be used to characterize safety and procedural outcomes over time.

The primary objective is evaluation of safety of the Edison Histotripsy System in this population. Final completion of the study is expected in October 2027.

“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 of HistoSonics, in the news release from the company.¹ “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.”

The Edison Histotripsy System is currently cleared in the US for the destruction of liver tumors. The device is also under investigation for use in primary solid renal tumors and pancreatic adenocarcinoma.³

REFERENCES

1. HistoSonics treats first patients evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH). News release. HistoSonics. March 30, 2026. Accessed April 1, 2026. https://www.businesswire.com/news/home/20260330349844/en/HistoSonics-Treats-First-Patients-Evaluating-the-Edison-Histotripsy-System-for-the-Treatment-of-Benign-Prostatic-Hyperplasia-BPH

2. The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy (WOLVERINE). ClinicalTrials.gov. Last updated February 27, 2026. Accessed April 1, 2026. https://clinicaltrials.gov/study/NCT07214675

3. Clinical trials portfolio. HistoSonics. Accessed April 1, 2026. https://histosonics.com/resources/evidence/