HistoSonics Edison Histotripsy System Evaluated at 12 Months in #HOPE4LIVER Trials

April 28, 2025—HistoSonics, developer of the Edison histotripsy system, announced 12-month follow-up clinical data from its prospective #HOPE4LIVER trials. The company stated that the Edison system uses focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors, including partial or complete destruction of unresectable liver tumors via histotripsy.

The #HOPE4LIVER trials (one trial in the United States and one trial in the United Kingdom and Europe) are designed to evaluate the safety and efficacy of histotripsy for the noninvasive destruction of primary (hepatocellular cancer [HCC]) and metastatic liver tumors.

Timothy Ziemlewicz, MD, and Clifford Cho, MD, are Coprincipal Investigators of the #HOPE4LIVER trials. Dr. Ziemlewicz is Professor of Radiology at the University of Wisconsin in Madison, Wisconsin. Dr. Cho is Chief Medical Officer at the University of Michigan Health-West in Ann Arbor, Michigan.

According to the company, the data reinforce histotripsy’s potential as a new category of noninvasive therapy for liver tumors. The full interim 12-month results were published by Dr. Ziemlewicz et al in Annals of Surgery.

The initial #HOPE4LIVER results—published by Mishal Mendiratta-Lala, MD, et al in Radiology—were used by the FDA to support de novo clearance, which was granted in October 2023, noted HistoSonics.

As summarized in the company’s press release, the #HOPE4LIVER trials enrolled 47 patients across 14 centers in the United States, United Kingdom, and Europe. Nineteen patients had HCC tumors and 28 patients had metastatic tumors, primarily from colorectal origins (39.3%). All patients treated with histotripsy in the trials had previously failed, were deemed ineligible for, or were intolerant of standard therapies such as surgery, radiation, and ablation.

HistoSonics reported the following findings from the 12-month follow-up analysis:

• 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin. This compares favorably to current, standard of care local regional therapies at 1 year.
• Histotripsy was shown to preserve critical collagen-rich structures—such as blood vessels and bile ducts—within the treated area because of its nonthermal, mechanical mechanism of action.
• Post hoc radiographic assessments of all follow-up imaging were conducted to account for preserved vascular structures and ensured precise interpretation of treatment outcomes. The assessments were done by an independent imaging core laboratory.
• Kaplan-Meier analysis showed overall survival rates were comparable to current systemic or combination therapies.