HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics

MINNEAPOLIS -- HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies.

WOLVERINE is a prospective, multi-center, single-arm feasibility trial designed to evaluate the safety of the Edison® Histotripsy System for the treatment of symptomatic benign prostatic hyperplasia (BPH). The trial is expected to enroll and treat up to 20 patients. Following treatment, participants will undergo imaging within 72 hours of the procedure to assess the immediate treatment effect. Patients will then be followed longitudinally to further evaluate safety and procedural outcomes.

“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.”

Benign prostatic hyperplasia is one of the most common urological conditions affecting aging men. Approximately 50 percent of men over the age of 50 and up to 80 percent of men over the age of 80 experience symptoms associated with BPH. Globally, more than 110 million men are affected by the condition, and its prevalence is expected to continue increasing as populations age.

The Edison Histotripsy System is currently cleared in the United States for the destruction of liver tumors. The use of the Edison System for the treatment of benign prostatic hyperplasia is currently limited to investigational use.