HistoSonics announced compelling 12-month follow-up data from its #HOPE4LIVER trials, demonstrating that the Edison Histotripsy System achieved 90% local tumor control across all treated liver tumors, positioning the non-invasive technology as a promising alternative to standard locoregional therapies for patients with primary and metastatic liver cancer.
The prospective trials enrolled 47 patients across 14 centers in the United States, United Kingdom, and Europe, treating tumors either originating in the liver or metastasizing to the liver, primarily from colorectal origins. All patients had previously failed, were deemed ineligible for, or were intolerant of standard therapies such as surgery, radiation, and ablation.
Strong Efficacy and Safety Profile Maintained
The 12-month analysis revealed sustained therapeutic benefits from the initial trial results that supported FDA De Novo clearance in October 2023. The primary efficacy endpoint was achieved in 95.5% of tumors treated, measured by complete tumor coverage (42/44 tumors). The co-primary safety endpoint was also met, with only 6.8% of patients (3/44) reporting major complications.
"It's very exciting to see these interim 12-month data," said Clifford Cho, M.D., Chief Medical Officer at the University of Michigan Health-West and Co-Principal Investigator of the #HOPE4LIVER trials. "These data confirm that the excellent local control and safety profile hinted at in our first #HOPE4LIVER paper are still there one year later."
The study population included 19 patients with hepatocellular carcinoma (HCC) and 28 with metastatic liver tumors, with 39.3% originating from colorectal cancer. Notably, there was only a single Adverse Device Effect reported beyond 30 days, which was classified as non-serious and resolved independently.
Unique Mechanism Preserves Critical Structures
The Edison System's non-thermal, mechanical mechanism of action demonstrated a unique ability to preserve collagen-rich structures such as blood vessels and bile ducts within the treated area. An independent imaging core laboratory conducted post hoc radiographic assessments to account for these preserved vascular structures and ensure precise interpretation of treatment outcomes.
"Local therapies have a long history of a steep learning curve before optimal outcomes can be achieved, while outcomes more equivalent to experienced users were achieved in this trial despite only a single investigator having prior experience treating patients with histotripsy," explained Tim Ziemlewicz, M.D., Professor of Radiology at the University of Wisconsin and Co-Principal Investigator of the trials.
Overall survival analysis using the Kaplan-Meier method showed survival rates comparable to current systemic or combination therapies. The complete 12-month interim results were published in the May 2025 issue of Annals of Surgery.
Expansion into Kidney Cancer Treatment
Building on the liver cancer success, HistoSonics has completed enrollment in its pivotal #HOPE4KIDNEY trial, evaluating the Edison System's safety and effectiveness in treating primary solid renal tumors. The prospective, open-label, single-arm trial enrolled 67 adult patients across 15 clinical sites in the United States.
The kidney trial targets patients with single, non-metastatic solid kidney masses of 3 cm or less, confirmed by imaging and biopsy. Participants must have an ECOG performance score of 0 to 2 and an estimated glomerular filtration rate of 45 mL/min or higher.
"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," said trial investigator William C. Huang, MD, FACS, professor and vice chair of urology at the NYU Grossman School of Medicine.
Technology Platform and Future Applications
The Edison Histotripsy System harnesses focused sound energy to create controlled acoustic cavitation, mechanically destroying and liquefying targeted tumors at the sub-cellular level. The platform enables physicians to plan, target, treat, and monitor tumor destruction with continuous real-time visualization and control.
Primary completion of the kidney trial is expected in September 2025, with final completion planned for July 2030. The company is also conducting the GANNON trial for pancreatic tumors in advance of planned regulatory submissions.
"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 of 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."
