HistoSonics Secures CE Mark Approval for Edison® Histotripsy System, Expanding Non-Invasive Liver Tumor Treatment Across Europe
HistoSonics has achieved a significant regulatory milestone with the receipt of CE Mark approval for its Edison® Histotripsy System, paving the way for commercialization of the company’s groundbreaking non-invasive focused ultrasound technology throughout Europe and other international markets that recognize the CE Mark. The approval represents a major step in expanding access to histotripsy, an innovative treatment approach designed to mechanically destroy liver tumors without surgery, radiation, or thermal energy.
The regulatory authorization follows growing global recognition of histotripsy technology and builds on previous approvals, including the U.S. Food and Drug Administration’s De Novo clearance for the Edison System. With CE Mark certification now in place, HistoSonics is positioned to introduce its platform to healthcare providers across the European Union, the United Kingdom, and additional regions that accept the CE Mark as evidence of compliance with medical device safety and performance standards.
The company believes this approval marks an important advancement not only for its commercial strategy but also for patients with liver tumors who have limited treatment options because they are not eligible for surgery or conventional local therapies.
Introducing a New Approach to Tumor Treatment
The Edison System is built around histotripsy, an emerging non-invasive therapeutic technology that uses highly focused ultrasound energy to mechanically break down targeted tissue. Unlike traditional thermal ablation techniques that destroy tumors through heat or cold, histotripsy employs precisely controlled acoustic energy to generate microscopic bubble clouds within the targeted tissue.
These bubbles rapidly expand and collapse, creating mechanical forces that liquefy unwanted tissue while preserving surrounding healthy structures. Because the treatment relies on mechanical rather than thermal destruction, it has the potential to reduce collateral damage and minimize many of the complications associated with conventional procedures.
The Edison System combines this technology with advanced image guidance, enabling physicians to visualize the treatment area in real time and accurately target liver tumors during a single non-invasive procedure.
The system is intended for the mechanical destruction of liver tumors, including the partial or complete treatment of unresectable liver tumors that cannot be removed surgically.
Expanding Treatment Options for Liver Tumor Patients
Liver tumors continue to represent one of the most challenging areas in oncology. Both primary liver cancers and metastatic tumors frequently require complex multidisciplinary treatment strategies, and many patients are unable to undergo surgery due to tumor size, location, underlying liver disease, or other medical conditions.
Traditional local treatment options include:
- Surgical resection
- Radiofrequency ablation
- Microwave ablation
- Cryoablation
- Radiation therapy
- Systemic drug treatments
While these therapies can provide meaningful clinical benefits, they are not suitable for every patient and may involve invasive procedures, hospitalization, or risks associated with thermal injury to surrounding tissues.
Histotripsy introduces an entirely different therapeutic approach by mechanically destroying tumors without incisions, needles, or ionizing radiation.
Because the procedure is non-invasive, physicians may potentially treat carefully selected patients while reducing recovery time and avoiding some of the risks associated with surgical intervention.
CE Mark Supported by Growing Clinical Evidence
The European approval was supported by an expanding body of clinical evidence demonstrating the safety and effectiveness of the Edison Histotripsy System in treating liver tumors.
Multiple clinical investigations have shown that histotripsy can accurately target tumor tissue while maintaining a favorable safety profile.
Researchers have reported that the technology enables highly localized tissue destruction with minimal impact on adjacent healthy liver tissue, an important consideration when treating patients with compromised liver function or tumors located near critical anatomical structures.
The growing evidence base has played an important role in supporting regulatory approvals and increasing physician interest in the technology as a potential addition to existing liver cancer treatment strategies.
HOPE4LIVER Trial Provided Key Clinical Support
A major component of the regulatory submission was data generated from the HOPE4LIVER pivotal clinical trial.
The international study enrolled patients across both the United States and Europe and included leading hospitals in:
- Germany
- Italy
- Spain
- United Kingdom
The multicenter design allowed investigators to evaluate the Edison System across diverse clinical environments and patient populations.
According to HistoSonics, the trial demonstrated:
- A 90% local tumor control rate at 12 months across the tumor types treated.
- A low overall complication rate.
- Favorable procedural safety.
- Successful treatment delivery across participating centers.
The company continues to collect longer-term follow-up data to further evaluate patient outcomes and validate the technology under broader real-world clinical conditions.
These additional data may provide further insight into long-term treatment durability and future clinical applications of histotripsy.
Building on Global Regulatory Momentum
The CE Mark approval follows a series of important regulatory achievements for HistoSonics over the past several years.
In October 2023, the Edison Histotripsy System received FDA De Novo clearance in the United States, recognizing the technology as a novel medical device category.
Since then, interest in histotripsy has continued to expand among clinicians, researchers, and healthcare institutions seeking innovative approaches for treating solid tumors.
European approval significantly broadens the company’s global commercial opportunity by opening access to healthcare systems that collectively treat large numbers of patients with liver cancer each year.
It also provides additional validation for histotripsy as an emerging therapeutic modality within image-guided oncology.
Company Highlights Importance of European Expansion
Mike Blue, Chairman and Chief Executive Officer of HistoSonics, described the CE Mark approval as another historic milestone for both the company and patients throughout Europe.
He emphasized that histotripsy represents a fundamentally different way of treating tumors by using focused ultrasound to mechanically destroy tissue without requiring invasive surgery or exposing patients to radiation.
According to Blue, the approval enables HistoSonics to begin working closely with leading hospitals and clinical centers across Europe to expand patient access to the technology.
He noted that many individuals with liver tumors currently have few effective treatment options, making the introduction of histotripsy particularly meaningful for this patient population.
Blue added that the company looks forward to collaborating with physicians throughout the European Union and the United Kingdom as commercialization progresses.
Phased Commercial Rollout Planned
Rather than launching broadly across all markets simultaneously, HistoSonics intends to introduce the Edison System through a phased commercialization strategy.
The initial rollout will focus on carefully selected centers of excellence specializing in liver tumor treatment.
These institutions are expected to serve as early clinical adoption sites where physicians can receive specialized training while generating additional real-world experience with the technology.
This phased approach is designed to support:
- Physician education
- Clinical implementation
- Collection of real-world evidence
- Development of treatment protocols
- Expansion of referral networks
As clinical experience grows, the company expects to broaden availability across additional hospitals and treatment centers.
Importance of Physician Training
HistoSonics emphasizes that successful implementation of histotripsy requires comprehensive physician education.
The Edison System should only be operated by healthcare professionals who have completed company-provided training programs.
These educational initiatives are intended to ensure physicians understand:
- Patient selection
- Device operation
- Image guidance techniques
- Treatment planning
- Safety procedures
- Clinical workflow integration
The company notes that treatment decisions should always remain based on the independent clinical judgment of qualified physicians.
Current Intended Use
Although the Edison System has received regulatory authorization for mechanical destruction of liver tumors, HistoSonics emphasizes that the device is not approved for the treatment of any specific disease, including cancer itself.
Similarly, regulatory authorities have not evaluated the system based on endpoints such as:
- Overall survival
- Five-year survival
- Cancer cure rates
- Long-term disease progression
Instead, the authorization focuses on the device’s intended use for mechanically destroying targeted liver tissue through histotripsy technology.
Clinical outcomes beyond tissue destruction continue to be evaluated through ongoing research and post-market clinical experience.
A Growing Role for Histotripsy
The CE Mark approval reflects increasing momentum behind non-invasive therapeutic technologies that seek to improve precision while reducing treatment-related morbidity.
As healthcare systems continue to emphasize minimally invasive interventions, image-guided procedures, and personalized oncology care, histotripsy may emerge as an important complementary option alongside surgery, systemic therapies, and conventional ablation techniques.
With commercialization now beginning across Europe, HistoSonics plans to work closely with hospitals, physicians, and research institutions to expand clinical experience and further evaluate the technology across broader patient populations. Continued clinical studies and real-world evidence collection will help define the long-term role of histotripsy in liver tumor management while supporting future innovation in non-invasive focused ultrasound therapies.
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 liquefy 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, MI, Minneapolis, MN and Madison, WI.