Technology & Science

Precision. Power. Healing.

Histotripsy Enterprises is redefining oncologic care through the world’s first non-invasive, non-thermal focused ultrasound platform for precise tissue ablation.

Built on decades of research pioneered at the University of Michigan and commercialized by HistoSonics, histotripsy represents a fundamental leap forward in how solid tumors can be treated — without incisions, heat, or radiation.

What Is Histotripsy?

Histotripsy is a novel therapeutic ultrasound technique that uses focused acoustic energy to mechanically destroy targeted tissue through controlled cavitation.

Unlike thermal ablation, radiofrequency, or ionizing radiation, histotripsy leverages short, high-amplitude sound pulses to generate a precise “bubble cloud” within the treatment zone. The rapid expansion and collapse of these microbubbles mechanically disintegrate cellular structures, turning tumor tissue into acellular debris that is naturally cleared by the body.

This purely mechanical mechanism of action eliminates collateral thermal damage, preserves vital structures such as vessels and ducts, and enables treatment near sensitive anatomical regions.

Mechanism of Action

Step 1: Image-Guided Targeting

Real-time ultrasound imaging identifies the tumor volume and surrounding anatomy.
The treatment focus is defined with millimeter precision.

Step 2: Acoustic Cavitation

Microsecond-duration, high-pressure ultrasound pulses converge at the focal point.
Cavitation nuclei form a transient bubble cloud inside the target tissue.

Step 3: Mechanical Tissue Fractionation

The violent collapse of the bubble cloud induces localized mechanical stress, disrupting cellular membranes and extracellular matrix.
The targeted volume is liquefied into acellular fragments, leaving surrounding tissue intact.

Step 4: Physiologic Clearance

The body’s immune and lymphatic systems resorb the debris naturally, often within days.

This precise, image-guided process allows physicians to visualize, control, and verify each treatment in real time.

The Edison® Histotripsy Platform

The Edison® System, developed by HistoSonics, is the first commercial histotripsy platform cleared by the U.S. FDA for liver tissue ablation.

It integrates advanced imaging, acoustic beam-forming, and feedback algorithms to ensure safe, reproducible treatment delivery.

Key System Features

Real-time imaging and monitoring for treatment visualization and endpoint validation.
Non-invasive delivery — no needles, catheters, or incisions required.
Precision beam control — treatment zone confined to the targeted volume.
Automated feedback — acoustic signatures confirm completion of ablation.
Scalable design — adaptable for different organ systems and clinical settings.

Regulatory Milestones

U.S. FDA clearance for liver tumor ablation (2023).
Ongoing clinical evaluation in kidney, pancreatic, and metastatic disease applications.
Global expansion initiatives underway in collaboration with leading research centers.

Clinical Evidence & Outcomes

Histotripsy has undergone extensive preclinical validation and multicenter clinical evaluation in hepatocellular carcinoma and metastatic liver lesions.

HOPE4LIVER Pivotal Trial Highlights

90 % technical success rate at 12-month follow-up.
High local tumor control with minimal post-procedural complications.
Mean treatment time significantly shorter than thermal ablation.
Patients reported rapid recovery and minimal discomfort.

Ongoing Research

Investigations into immune activation following mechanical tumor disruption.
Early data suggest histotripsy may induce systemic anti-tumor effects by releasing tumor antigens and stimulating immune recognition.

These outcomes reinforce histotripsy’s potential as both a curative local therapy and a systemic immunologic adjunct.

Advantages Over Conventional Therapies

Attribute	Histotripsy	Thermal Ablation	Radiation	Surgery
Mechanism	Mechanical (acoustic cavitation)	Heat-based	Ionizing radiation	Resection
Invasiveness	Non-invasive	Minimally invasive	Non-invasive	Invasive
Precision	Millimeter-level focus	Limited by heat diffusion	Limited by radiation spread	Dependent on access
Collateral Damage	Minimal	Moderate	Variable	High
Recovery	Rapid, outpatient	1–3 days	Variable	Weeks
Repeatability	High	Limited by tissue scarring	Moderate	Limited
Immunologic Effect	Potential stimulation	Thermal necrosis	Variable	Variable

Research & Development

Academic Foundation Histotripsy originated from decades of acoustic physics and biomedical engineering research at the University of Michigan, led by the Histotripsy Research Group. Their work established the foundational physics of bubble dynamics, pulse sequencing, and tissue interactions that underpin current clinical systems.

Current R&D Focus

Extending applications to kidney, pancreas, breast, and brain tumors.
Optimizing dual-frequency pulse regimes to enhance cavitation precision.
Integrating AI-driven treatment mapping and acoustic feedback loops.

Studying immune modulation effects in combination with checkpoint inhibitors.

Integration with the Hope Centers

The deployment of the Edison® histotripsy platform forms the technological backbone of our Hope Centers.

Each site will feature fully equipped histotripsy suites with certified operators, image-guided control systems, and a care model that integrates cutting-edge technology with compassionate, patient-centered delivery.

Hope Center Technology Advantages

Uniform clinical protocols and data capture across all centers.
Continuous physician training and certification programs.
Centralized monitoring and quality assurance for safety and reproducibility.
Integration with ongoing clinical trials and post-market registries.

Through this distributed model, Histotripsy Enterprises ensures consistent quality, regulatory compliance, and scalability as the network expands nationwide.

Future Outlook

Histotripsy stands at the intersection of biomedical engineering, oncology, and patient experience.

With continued collaboration between academia, industry, and healthcare partners, the therapy is poised to expand into multi-organ indications and broader therapeutic applications.

Our long-term vision is to make histotripsy a frontline therapeutic modality, offering patients safe, effective, and humane treatment options — and giving physicians a precise, controllable tool to transform outcomes across cancer care.