HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors

Pivotal Study Advances to Establish Histotripsy as a Non-Thermal, Surgery-Free Alternative to Destroy and Liquefy Kidney Tumors

HistoSonics, Inc., the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, today announced the completion of patient enrollment in its pivotal #HOPE4KIDNEY trial. This prospective, multi-center, single-arm trial is designed to evaluate the safety and effectiveness of the Edison System in destroying kidney tissue by treating primary solid kidney tumors.

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Edison Histotripsy System Procedure for Kidney Tumor Animation

The 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 post-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 FDA-approved 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.

The Edison System is 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.

“Our vision is for the Edison System to become a foundational, non-invasive solution across a wide range of clinical applications,” said Mike Blue, President and CEO, HistoSonics. “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.”

Dr. William C. Huang, MD FACS, Professor and Vice Chair of Urology at the NYU Grossman School of Medicine serves as a principal investigator at the NYU Langone Medical Center, the top enrolling site in the trial. Dr. Huang commented, “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, serves as a principal investigator for one of the participating sites in the trial. Dr. McDonald commented, “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.”

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, 5-year survival or overall survival).

United States Intended Use Statement:

The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US 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, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: www.histosonics.com. For patient-related information please visit: www.myhistotripsy.com.

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