The groundbreaking histotripsy therapy platform, developed by the US medical device company HistoSonics, Inc.(USA), uses focused ultrasound to liquefy and destroy targeted liver tumours under real-time image guidance, without the invasiveness or toxicity of traditional oncological treatments. Pulsed sound energy waves induce micro-bubbles, which form and collapse in microseconds creating mechanical forces strong enough to destroy liver tissue at cellular and sub-cellular levels, non-invasively without the need for surgery, radiation, or chemotherapy.
 

This represents a powerful and unique therapeutic approach that is redefining the current paradigm of cancer treatment. However, as with any new medical device, it must undergo preclinical validation and safety assessments to meet regulatory requirements before clinical application. During its preclinical stage, part of the validation phases of the Edison™ Histotripsy System for liver tumour treatment in animal models were conducted at the state-of-the-art facilities of the Comparative Medicine and Bioimage Centre of Catalonia (CMCiB)-Germans Trias i Pujol Research Institute (IGTP), hosting HistoSonics US R&D engineering team and KOL's, helping them advance this technology to the #HOPE4LIVER and THERESA clinical trials (US & EU/UK). Several Catalan hospitals participated in the THERESA feasibility study (first-in-human) trials, which demonstrated safety and technical success for histotripsy in patients with unresectable liver tumours.
 

"Thanks to the facilities, the team, and the collaborative spirit of the CMCiB we have been able to move forward in areas of significant unmet medical needs", shares Carolina Alemany, Clinical and R&D engineer at HistoSonics, Inc.
 

The company is currently focused on commercialising their system in select global markets for liver treatment (US, United Arab Emirates, UK, and Hong Kong) while expanding histotripsy applications into other organs like kidney, for instance. Their technology has already treated over 2,500 patients worldwide following the Food and Drug Administration (FDA) clearance for the destruction of liver tumours in October of 2023.
 

Although HistoSonics is actively pursuing CE marking to enable broader commercialisation in Europe a crucial milestone has been reached in the UK, by treating the first patient in Europe. The technology was fast-tracked in May 2025 by the UK's Innovative Devices Access Pathway through the Unmet Clinical Need Authorisation (UCNA) regulatory program. Overseen by the Medicines and Healthcare products Regulatory Agency (MHRA), NHS patients have already early access to histotripsy prior to full regulatory approval.
 

HistoSonics' success story marks a turning point in how tumours are already being treated and how cancer will be addressed in the future, bringing forth a hopeful new era for patients with limited therapeutic options and for society as a whole. Its cutting-edge, disruptive technology is paving the way for safer, more precise, and truly transformative interventions in oncology, and will undoubtedly drive meaningful medical progress in the years to come.
 

Image credit: HistoSonics. Image source: Saint John's Cancer Institute Blog. 

Related links

• HistoSonics Announces Published Results of Phase I Liver Tumor Trial
• HistoSonics Completes Enrollment in #HOPE4KIDNEY Trial Evaluating Non-Invasive Histotripsy to Treat Kidney Tumors
• HistoSonics' Edison Histotripsy System Gains Great Britain Early Market Access Under Unmet Clinical Needs Authorisation