HistoSonics’ Edison® System, an ultrasound-based tool that employs histotripsy to non-invasively destroy tumours without relying on surgery or radiation, is expected to become available to select National Health Service (NHS) facilities in the UK this summer.
This early market access approval was granted on May 29, 2025 and was issued under the Unmet Clinical Need Authorisation (UCNA), a component of the UK’s Innovative Devices Access Pathway (IDAP). The decision allows limited clinical deployment of the Edison® Histotripsy System, offering a non-invasive treatment option for patients with few available alternatives.
Origin and overview of HistoSonics
Headquartered in Plymouth, Minnesota, HistoSonics was founded in 2009 as a start-up spin-off from the University of Michigan, based on research in histotripsy—a non-invasive ultrasound technology that uses focused sound waves to mechanically destroy targeted tumors. Initially, the company focused on prostate disease before shifting its attention to solid tumor treatments, particularly liver cancer.
The development of the histotripsy system started as early as 2001 at the University of Michigan under the leadership of Professor Zhen Xu. Following the formation of HistoSonics, a prototype device, called the Vortx RX™, was created for treating Benign Prostatic Hyperplasia (BPH) using the technology. In May 2013, the U.S. FDA approved a human pilot trial using the device, with 28 patients treated from July 2013 to June 2016.
During the 38th J.P. Morgan Healthcare Investment Conference held in January 2020, The Observer recognized HistoSonics as one of the notable U.S. healthcare companies for its next-generation iteration of the histotripsy platform—the Edison® System—introduced as part of its own commercialization efforts. In 2023, HistoSonics received clearance from the U.S. Food and Drug Administration’s (FDA) through a De Novo Classification Request to treat liver tumors in humans using its Edison® System. Since then, the start-up has expanded clinical use and raised capital to support commercialization efforts.
In this article, we further examine HistoSonics’ patenting activity and explore the underlying concepts and intellectual property behind the Edison® System to better understand the company’s portfolio on histotripsy.
HistoSonics: Patenting activity
HistoSonics’ patent filings from 2018 to 2025 reveal notable trends that align with key clinical and financial milestones The initial wave of filings in 2018 coincided with the company’s presentation of its Robotically Assisted Sonic Therapy (RAST™) at the CED Life Science Conference, marking a significant step in its transition from research to clinical readiness.
Patent activity resumed in 2020, supported by the $40M Series C-1 financing that happened in June. Building on the momentum from a $54 million Series C financing in 2019, these filings likely reflect advancements in the Edison® System such as imaging, targeting precision, and user interface design. This was further continued in October 2020, when HistoSonics received FDA approval to conduct its #HOPE4LIVER U.S. clinical study, marking a key step toward using histotripsy for the treatment of liver tumors.
In January 2021, the company also received approval to conduct its #HOPE4LIVER clinical study in Europe. Later that year, HistoSonics achieved a major milestone in the U.S., where the first patient was treated in the domestic arm of the study. Subsequently, the first patient was also treated in the European trial. In 2022, patent activity peaked, coinciding with the publication of results from its THERESA (Phase I) liver tumor trial. Patent filings continued in 2023, aligning with FDA’s clearance for the company to use the Edison® System. This period also aligns with HistoSonics’ reported focus on the commercialization of the Edison® System, followed by a $102 million Series D funding round in August 2024.
HistoSonics: Top Jurisdictions
The majority of HistoSonics’ patents are filed in the United States. This aligns with the company being headquartered in Minnesota and the concentration of its clinical studies conducted in the country. This is followed by the PCT System, which suggests an interest in maintaining options for broader international protection. Other jurisdictions with multiple filings include Australia, the European Patent Office, Canada, and China. Additional filings in Brazil and Singapore indicate some level of future consideration in those countries.
HistoSonics: Top Technology Areas
The patents filed by HistoSonics fall under the CPC classifications A61N, A61B, G16H, and B06B, reflecting the company’s focus on non-invasive therapeutic technologies. Together, these classifications illustrate a technological approach that combines therapeutic ultrasound, precision guidance, and control systems. A61N relates to ultrasound therapy, directly covering the company’s use of the technology for non-invasive tissue destruction while A61B represents HistoSonics’ imaging and robotic targeting systems. G16H, which covers health data, suggests integration of software for monitoring and planning, and B06B supports the core mechanism behind histotripsy.
HistoSonics: Top Law Firms
The top law firm representing HistoSonics is Shay Glenn, indicating its primary involvement in managing the company’s intellectual property in the United States. This is followed by J A Kemp, which handles patents filed in Europe, reflecting HistoSonics’ growing presence in the region. RnB IP is associated with four patents filed in Australia, which suggests an effort to maintain IP protection in a market where future clinical or commercial initiatives could be considered. Additionally, King & Wood Mallesons is responsible for patents filed in Asia, specifically in China.
The Edison® System and the patents behind it
The Edison® System is HistoSonic’s non-invasive therapeutic platform that uses histotripsy, a focused ultrasound technology, to mechanically destroy targeted tissues. In the following sections, we explore key patents that contribute to the development and underlying mechanisms of this technology.
Using ultrasound to destroy liver tumors
Traditional surgical procedures for tumor removal typically involve invasive techniques such as making incisions and using anesthetics, followed by extended recovery periods. These methods can carry risks such as bleeding, infection, and damage to surrounding healthy tissues. While radiation therapy offers a non-invasive approach, it relies on ionizing radiation which can still affect nearby tissues.
U.S. Patent 11,813,484 describes a system and method for delivering focused ultrasound therapy using acoustic cavitation. The system features an array of ultrasound transducers configured to focus energy at specific locations within the tissue. Each transducer element is individually controlled, allowing for adjustable pulse delivery and flexible shaping and steering of the focal zone.
To induce acoustic cavitation, the system sets the pulse repetition frequency (PRF) of the transducer within specific ranges: 400 and 900Hz, 600 and 900Hz, 500 and 700Hz, or exactly 600Hz.
The patent further describes the ability to move the focus of a transducer array to target different treatment locations within a target tissue volume. This targeting treatment can be based on predefined spatial coordinates or other external input sources, depending on the implementation. The system supports treatment patterns such as rectilinear and radial.
The patent was represented by Douglas Limbach, Walter Glenn, Richard Shoop, et al from Shay Glenn LLP. It was filed on November 27, 2019 and granted on November 14, 2023. The listed inventors include Jonathan Cannata, Ryan Miller, Alexander Duryea, Dejan Teofilovic, Zeljko Mladenovic, Aleksandra Rakic, and Joshua Stopek.
Robotics in the fight against liver tumors
U.S. Patent No. 11,980,778 on the other hand discloses a mobile ultrasound therapy system built around a mobile cart-based design that integrates several hardware components. Central to the system is the ultrasound therapy transducer, which was described in the previous patent, connected to the end of a robotic arm, allowing controlled positioning relative to the patient.
The cart structure houses the said robotic arm and therapy transducer, and a control panel with an installed software for the user interface. The transducer also includes an integrated imaging system consisting of an imaging probe to produce real-time images of the cavitation bubble cloud during treatment. The robotic arm provides precise mechanical alignment based on the received control signals and commands from the control system.
The transducer circuitry employs an inductor-capacitor (LC) circuit where the transducer functions as a capacitive element in parallel with an inductor to generate high-voltage pulses. A signal generator initiates the process by sending a low-voltage pulse to an optically isolated insulated gate bipolar transistor (IGBT) driver, which in turn activates the IGBT transistor to control energy flow through the inductor.
In its basic form, the system can deliver up to 3 kV or up to about 4.5 kV peak-to-peak. An alternative version using an autotransformer with a center-tapped inductor can achieve up to 6 kV peak-positive by adjusting the winding ratio and pulse duration. Additional components include capacitors for frequency tuning, diodes for waveform shaping, and fast-acting fuses for overcurrent protection. The circuit also supports a negative voltage supply configuration to enhance handling safety.
The system also incorporates a cooling mechanism designed to manage the thermal load during extended histotripsy procedures. This includes a dynamic transducer motion, which shifts the focal point between different regions of the tissue. As one area receives treatment, adjacent regions are given time to dissipate accumulated heat, preventing localized thermal buildup. Additionally, the system also features one or more displays for real-time monitoring of treatment parameters.
The patent was filed on November 27, 2019 and was granted on November 14, 2023, with HistoSonics represented by Douglas Limbach, Walter Glenn, Richard Shoop, et al from Shay Glenn LLP. Jonathan Cannata, Ryan Miller, Alexander Duryea, Dejan Teofilovic, Zeljko Mladenovic, Aleksandra Rakic, and Joshua Stopek are the listed inventors.
The future of HistoSonics’ histotripsy
Looking ahead, HistoSonics’ histotripsy technology continues to be the subject of ongoing research and clinical evaluations. Current clinical trials from their portfolio are recruiting participants to evaluate the feasibility of using the technology for treating conditions such as renal tumors and pancreatic adenocarcinoma. As clinical data continues to accumulate and regulatory processes advance, the role of histotripsy in the broader field of non-invasive therapies will become clearer, contributing to ongoing developments in image-guided and robotic-assisted medical technologies.
Note: The image used in this article is for illustrative purposes only and does not depict the actual system developed by HistoSonics.
