#HOPE4KIDNEY Trial Enrollment Complete

HistoSonics Inc. has completed patient enrollment in its pivotal #HOPE4KIDNEY trial, which aims to determine the safety and effectiveness of its Edison Histotripsy System in destroying kidney tumor tissue.

The prospective, multi-site trial enrolled patients with a single, non-metastatic solid kidney mass ≤3 cm, confirmed by imaging and biopsy. Subjects will be followed for five years after their procedure, with evaluations at multiple time points, including 14-day, 30-day, 90-day, 180-day, and annual assessments. The Edison System remains in investigational use for kidney applications and is not yet approved by the U.S. Food and Drug Administration for this indication. Data from the #HOPE4KIDNEY trial is expected to support a future submission for regulatory clearance to expand the use of histotripsy to treat kidney tissue/tumors.

“Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,” HistoSonics President/CEO Mike Blue said. “Completing enrollment in our 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 Edison System is touted as the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumors without surgery, radiation, or systemic therapies. Unlike invasive surgical approaches, histotripsy does not require incisions and enables real-time imaging and treatment monitoring, allowing physicians to target and control tissue destruction while sparing surrounding structures.

“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,” stated William C. Huang, M.D. professor and vice chair of Urology at the NYU Grossman School of Medicine, and principal investigator at the NYU Langone Medical Center (the top enrolling trial site).

“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,” added Dr. Michael McDonald, assistant professor of Urology at the University of Central Florida College of Medicine and urologic surgeon at AdventHealth at Celebration Florida. He is a principal trial investigator at one of the participating sites.

The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, five-year survival or overall survival).

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