HistoSonics announced today that it has completed patient enrollment of its pivotal #HOPE4KIDNEY trial to evaluate its Edison histotripsy system in treating kidney tumors.
The Edison system has already received FDA de novo clearance for treating liver tumors; HistoSonics says major academic centers and hospitals across the U.S are adopting it. The Edison system uses focused ultrasound energy. Delivered via a robotic arm, histotripsy mechanically destroys and liquifies targeted tissue and tumors — without the invasiveness or toxicity of traditional procedures.
The #HOPE4KIDNEY trial represents Plymouth, Minnesota–based HistoSonics seeking to expand the use of Edison to treat tumors in other parts of the body, with trial results expected to support future regulatory submissions to achieve clearance for histotripsy to treat kidney tumors. The new clinical trial has enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years post-procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments.
“Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,” HistoSonice CEO Mike Blue said in a news release.
“Completing enrollment in our pivotal kidney tumor trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumor types and indications. This achievement reflects the dedication of our team and clinical partners and brings us closer to transforming the treatment of solid tumors without the need for surgery.”
The NYU Langone Medical Center is the top enrolling site in the trial, with Dr. William C. Huang, professor and vice chair of urology at the NYU Grossman School of Medicine, serving as a principal investigator. Said Huang: “Histotripsy offers a novel, completely non-invasive treatment paradigm for kidney tumors that precisely images and treats tumors while preserving surrounding critical structures, thereby minimizing the morbidity associated with traditional surgical and thermal ablative techniques.”
Dr. Michael McDonald, assistant professor of urology at the University of Central Florida College of Medicine and urologic surgeon at AdventHealth at Celebration Florida, is another principal investigator. He said: “HistoSonics represents a paradigm shift proving that the most profound treatments for both benign and malignant diseases need not be the most invasive. The ability to precisely target and destroy tumors without scalpel or scar is the next step in the evolution of non-surgical intervention.”
HistoSonics has been generating a lot of buzz lately, with The Financial Times reporting a month ago that several major medtech companies are considering an acquisition.
