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HistoSonics’ Histotripsy System Demonstrates 90% Local Tumor Control at 12 Months in #HOPE4LIVER Trials

via Business Wire

Durable local control and favorable safety profile position histotripsy as a non-invasive alternative to standard of care locoregional therapy

HistoSonics, the developer of the Edison Histotripsy System, announced today 12-month follow-up clinical data from its prospective #HOPE4LIVER trials, designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular cancer-HCC) and metastatic liver tumors.

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The Edison System, which received U.S. Food and Drug Administration (FDA) De Novo clearance in October 2023, uses focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors without the invasiveness or toxicity of traditional procedures. These latest data reinforce histotripsy’s potential to emerge as a new category of non-invasive therapy for patients suffering from liver tumors.

The #HOPE4LIVER trials enrolled 47 patients across 14 centers in the United States, United Kingdom and Europe, with tumors either originating in the liver or metastasizing to the liver, primarily from colorectal origins. The initial trial results published in 2024 were utilized by the FDA to support the De Novo marketing authorization in the US. In the trials, all patients treated with histotripsy had previously failed, were deemed ineligible for or were intolerant of standard therapies such as surgery, radiation, and ablation. As previously reported, the primary efficacy endpoint was successfully achieved in 95.5% of tumors treated as measured by the number of tumors where complete tumor coverage was achieved (42/44). Additionally, the co-primary safety endpoint of the trial was also achieved with only 3/44 (6.8%) of patients reporting a major complication. Adding to the strong safety profile, there was only a single Adverse Device Effect (ADE) reported beyond 30-days, and it was classified as non-serious, resolving on its own.

Nineteen patients had tumors originating from the liver (HCC) and 28 had metastatic tumors of the liver, with the most frequent originating from the colon or rectum (39.3%). A key finding in the 12-month follow-up analysis is a 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin which compares favorably to current standard of care local regional therapies at one year.

The 12-month evaluation highlighted histotripsy's unique tendency to preserve critical collagen-rich structures, such as blood vessels and bile ducts, within the treated area due to its non-thermal, mechanical mechanism of action. An independent imaging core laboratory conducted post hoc radiographic assessments of all follow-up imaging to account for preserved vascular structures and ensured precise interpretation of treatment outcomes. Overall survival was analyzed using the Kaplan-Meier method, showing survival rates comparable to current systemic or combination therapies. Full interim 12-month results are published in the May 2025 issue of Annals of Surgery.

“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. “As important as the initial report of #HOPE4LIVER was to the world of liver-directed therapy, it was absolutely necessary to follow those very early observations with longer-term data. We are not yet at a point where we can fully characterize the longitudinal effects of this brand-new technology, but these data confirm that the excellent local control and safety profile hinted at in our first #HOPE4LIVER paper are still there one year later. We will continue to do our due diligence with longer-term follow up, but I think these findings strongly support the rapid clinical adoption that we have seen for histotripsy.”

“The one-year outcome data for the #HOPE4LIVER trials are truly remarkable as the safety profile was maintained throughout the first year of follow-up and, as we gained understanding of the imaging findings post-histotripsy, it became clear that the treatment effect was durable,” said Tim Ziemlewicz, M.D., Professor of Radiology at the University of Wisconsin and Co-Principal Investigator of the #HOPE4LIVER trials. “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. This speaks to the broad applicability of histotripsy and ensures that patients will have access to expert-level treatment from the earliest clinical adoption. This expands the number of patients we can successfully treat with local therapies, particularly for patients with tumors in critical locations, such as along central bile ducts, where histotripsy is rapidly becoming a leading treatment option.”

Histotripsy harnesses focused sound energy to create controlled acoustic cavitation, mechanically destroying and liquefying targeted liver tumors at the sub-cellular level. The HistoSonics platform uniquely enables physicians to plan, target, treat, and monitor tumor destruction with continuous real-time visualization and control—capabilities unmatched by any existing modality. Following FDA De Novo clearance in October 2023, the Edison Histotripsy System has been successfully adopted across leading U.S. academic centers, integrated health systems, and community hospitals eager to offer this breakthrough, non-invasive treatment to patients. Additional clinical trials are ongoing to evaluate the safety and efficacy of histotripsy in the non-invasive treatment of kidney tumors (#HOPE4KIDNEY Trial NCT05820087) and pancreatic tumors (GANNON Trial NCT06282809) in advance of planned regulatory submissions in both organs.

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, 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/.

“The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes” published in Annals of Surgery by Ziemlewicz, et.al. is licensed under CC BY-NC-ND.

“The one-year outcome data for the HOPE4LIVER trial are truly remarkable as the safety profile was maintained throughout the first year of follow-up ... and it became clear that the treatment effect was durable," Tim Ziemlewicz MD.

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