HistoSonics has secured early market access for its Edison Histotripsy System in Great Britain (GB), targeting liver tumours under the Unmet Clinical Need Authorisation (UCNA).
This access is part of the UK’s Innovative Devices Access Pathway (IDAP) programme, which aims to integrate transformative medical technologies into the healthcare system quickly.
The Edison System is one of eight devices selected for this programme in 2024, reflecting its potential to address critical healthcare requirements in the UK.
The UCNA designation permits controlled early use of the Edison System for patients with primary or metastatic liver tumours. The Medicines and Healthcare products Regulatory Agency (MHRA) is said to have conducted a comprehensive evaluation before approving the device, acknowledging its potential public health benefits.
According to HistoSonics, the Edison System is the first device using histotripsy, a non-invasive focused ultrasound technology that mechanically liquefies tumours without surgery, radiation, or systemic therapies.
The system was cleared by the US Food and Drug Administration (FDA) in October 2023 through the De Novo pathway. It allows physicians to plan, target, and monitor tumour destruction with real-time visualisation and control.
Following FDA clearance, major academic centres and hospitals in the US have adopted the Edison System, including integrated health systems and community hospitals. Clinical trials are underway to expand histotripsy’s applications to kidney and pancreatic tumours, with future regulatory submissions planned for these indications.
HistoSonics said that it is working to strengthen clinical relationships in the UK based on previous pioneering trials in liver and kidney treatments. These relationships are expected to support histotripsy’s adoption in major UK health centres.
As HistoSonics implements UCNA authorisation, it expects to collaborate with MHRA to assess patient outcomes through a post-market surveillance programme. Concurrently, the company is seeking European regulatory approval via the European Conformity process (CE marking), which would facilitate broader commercial availability across Europe.
HistoSonics president and CEO Mike Blue said: “Securing GB controlled access through the IDAP pilot programme is a tremendous milestone for HistoSonics and signals clear recognition of our technology’s potential to transform healthcare.
“We are honoured to work alongside the NHS and UK regulatory and access partners to bring histotripsy to patients across the UK, many of whom have limited options. This progress builds on our strong clinical track record in the US, and our growing base of clinical evidence globally.”
