MINNEAPOLIS — Medical device company HistoSonics has completed patient enrollment for its #HOPE4KIDNEY clinical trial, a pivotal study evaluating the use of its Edison® Histotripsy System to non-invasively destroy kidney tumors. The trial marks a major step forward in the company’s push to establish histotripsy as a surgery-free alternative for treating solid kidney tumors.
The single-arm, multi-center study enrolled patients diagnosed with a single, non-metastatic solid kidney tumor measuring 3 cm or less. The trial will track patient outcomes over five years, with scheduled assessments at intervals ranging from 14 days to annual follow-ups. While the Edison System remains investigational for kidney tumor applications, the data from this study is expected to support a future FDA submission seeking clearance for expanded use.
Histotripsy is a novel non-thermal, non-invasive focused ultrasound technology that mechanically liquefies tumors without incisions, radiation, or systemic drugs. Unlike traditional surgical approaches, it allows physicians to visualize and control tissue destruction in real time, minimizing risk to nearby healthy structures.
“This milestone is a critical step toward making histotripsy a foundational treatment option across a broad range of solid tumors,” said HistoSonics CEO Mike Blue. “Completing enrollment in the #HOPE4KIDNEY trial reflects the dedication of our team and partners and moves us closer to transforming cancer treatment through non-invasive innovation.”
Leading urologists involved in the trial highlighted the system’s precision and potential to reduce treatment-related complications. Dr. William C. Huang, Professor and Vice Chair of Urology at NYU Grossman School of Medicine and principal investigator at the top-enrolling site, praised the technology for its ability to treat tumors while preserving critical surrounding structures.
Dr. Michael McDonald, Assistant Professor of Urology at the University of Central Florida and surgeon at AdventHealth, added, “HistoSonics proves that the most effective treatments don’t have to be the most invasive. Destroying tumors without scalpel or scar represents a fundamental shift in how we think about surgical intervention.”
While the Edison System has not yet been approved for any specific disease outcomes, the completion of enrollment in this trial signals growing momentum behind histotripsy as a transformative tool in tumor treatment.
