HistoSonics Edison System to Treat Kidney Tumors Completes Pivotal Trial Enrollment

June 11, 2025—HistoSonics, Inc. recently announced the completion of patient enrollment in the #HOPE4KIDNEY pivotal trial of its Edison histotripsy system. The Edison platform uses a nonthermal, noninvasive focused ultrasound technology to mechanically liquefy tumors without surgery, radiation, or systemic therapies.

According to the company, the prospective, multicenter, single-arm #HOPE4KIDNEY trial is designed to evaluate the safety and effectiveness of the Edison system in destroying kidney tissue by treating primary solid kidney tumors.

HistoSonics reported that the trial enrolled patients with a single, nonmetastatic solid kidney mass ≤ 3 cm, confirmed by imaging and biopsy. The patients will be followed for 5 years postprocedure, with evaluations at 14, 30, 90, and 180 days as well as annually.

“Histotripsy offers a novel, completely noninvasive 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,” commented William C. Huang, MD, in the company’s press release.

Michael McDonald, MD, added, “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 nonsurgical intervention.”

HistoSonics advised that the Edison system is not yet FDA approved for kidney applications and remains an investigational device for this indication. Data from the #HOPE4KIDNEY trial are expected to support a future submission for regulatory clearance to expand the use of histotripsy to treat kidney tissue/tumors.

In the United States, the Edison system is intended for the noninvasive mechanical destruction of liver tumors, including partial or complete destruction of unresectable liver tumors via histotripsy. It has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes.