HistoSonics and Cambridge University Unveil Europe’s First Edison™ Histotripsy System Powered by Li Ka Shing Foundation Gift

Milestone marks company’s initial entry into the United Kingdom, following Unmet Clinical Needs Authorization (UCNA) Approval by MHRA

HistoSonics, the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, announced today that Addenbrookes Hospital of Cambridge University Hospital Foundation and Trust will be the first site in the United Kingdom and European continent to offer histotripsy to both NHS and private patients. This was made possible through a generous donation by the Li Ka Shing Foundation (LKSF) as well as the expedited limited market access granted by the MHRA in April 2025.

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The milestone marks HistoSonics’ official entry into the UK and European market. HistoSonics won a coveted place in the Innovative Device Access Pathway pilot in 2024 and through this program, in partnership with the DHSC, MHRA, NIHR, NHSE, and NICE expedited access to patients. HistoSonics will continue to work with UK healthcare stakeholders on our aligned goal of urgently expanding access for all NHS patients.

The Li Ka Shing Foundation, established in 1980 by Hong Kong philanthropist Sir Ka-shing Li, has contributed nearly US$4 billion to advancing education, medical research and services, and poverty alleviation across the USA, UK, Canada, and Asia. Recognizing the transformative potential of technological innovation in healthcare, the Foundation’s latest gift to the University of Cambridge will build upon its previous donations of five Edison systems with three to Hong Kong, one to Singapore, and one recently to Stanford University. This new gift not only heralds the introduction of the first Edison system in the UK and Europe but also celebrates the enduring partnership between the Li Ka Shing Foundation and Cambridge in their collaborative efforts to fight cancer. By supporting cutting-edge medical technologies that can deliver low cost and highly efficient solutions, the Foundation hopes to enhance patient access with improved healthcare around the world.

“This donation is an historic milestone that brings non-invasive treatment of liver tumors using histotripsy to the UK,” said Mike Blue, President and CEO, HistoSonics. “We are grateful to the Li Ka Shing Foundation for their visionary support. With Addenbrookes as our first NHS hospital site under UCNA, we are laying the foundation for future expansion into innovation driven hospitals across the UK.”

The Edison System, which received FDA De Novo clearance in October 2023, uses non-invasive therapeutic focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors without the invasiveness or toxicity of traditional procedures, reducing the risks of bleeding, infection, and damage to surrounding non-targeted tissue. HistoSonics' initial FDA clearance is for the destruction of liver tumors, with ongoing studies focusing on kidney tumors (HOPE4KIDNEY Trial NCT05820087) and pancreas tumors (GANNON Trial NCT06282809).

Professor Deborah Prentice, Vice-Chancellor of the University of Cambridge, said: “We are very fortunate that through the generosity of Sir Ka-shing Li, Addenbrooke's Hospital in Cambridge will be able to use cutting-edge histotripsy technology to improve outcomes for NHS patients. It is technology such as this that allows Cambridge to remain at the forefront of understanding and treating tumors, a position we aim to strengthen further with Cambridge Cancer Research Hospital.”

With installations soon to be in five countries including the US, UK, Hong Kong, Singapore and the United Arab Emirates, HistoSonics is actively expanding access to its histotripsy platform and is working closely with clinical leaders, national health systems, and philanthropic partners to accelerate global adoption of histotripsy as a new category of health care. HistoSonics is also pursuing broader UK and European market access via CE marking.

United Kingdom Intended Use Statement:

The Edison System is intended for the non-invasive mechanical destruction of liver tumours, including the partial or complete destruction of unresectable liver tumours via histotripsy. This includes malignancy linked to primary liver cancer and cases of metastatic disease in the liver. The device should only be used by people who have completed training performed by HistoSonics Inc., and its use guided by the clinical judgement of an appropriately trained physician. Users must read this user guide to understand the warnings, precautions, and clinical trial summary, including reported adverse events.

The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival).

United States Intended Use Statement:

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, prostate, 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.

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