Edison Histotripsy System Study Underway

HistoSonics has successfully treated the first patients in a prospective trial evaluating the Edison Histotripsy System for benign prostatic hyperplasia (BPH) treatment. The patients underwent therapy 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 treatment approach in a clinical trial and potentially benefit patients with BPH in the future,” said Dr. Peter Chiu, study investigator and associate professor at 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.”

The Edison System is a 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 study designed to evaluate the safety of the Edison Histotripsy System in treating symptomatic BPH. The trial is expected to enroll and treat up to 20 patients. After treatment, participants will undergo imaging within 72 hours of the procedure to assess the therapy’s immediate 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,” HistoSonics Chairman/CEO Mike Blue stated. “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.”

Benign prostatic hyperplasia is one of the most common urological conditions affecting aging men. Approximately 50% of men older than 50 and up to 80% of men older than 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 destroying liver tumors. The use of the Edison System for treating benign prostatic hyperplasia is currently limited to investigational use.

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy using the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing its Edison System in the United States and select global markets for liver treatment while expanding its histotripsy applications into other organs like the kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Mich., and Minneapolis.