HistoSonics’ Edison Histotripsy System Gains Great Britain Early Market Access Under Unmet Clinical Needs Authorisation

HistoSonics, announced today that its Edison Histotripsy System for the non-invasive destruction of liver tumours has been granted controlled early limited market access in Great Britain under a Unmet Clinical Need Authorisation (UCNA). This designation, available through the UK’s Innovative Devices Access Pathway (IDAP) programme, allows controlled early access to histotripsy for certain patients with liver tumours, marking a significant milestone in expanding treatment options for one of the UK’s most urgent unmet medical needs in oncology.

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The IDAP programme, launched by the UK Government to help fast-track transformative medical technologies into the healthcare system, selected the Edison System as one of just eight available application spots in 2024, based on histotripsy’s potential to meaningfully address the UK’s top current and future healthcare needs. Following a rigorous evaluation process, the UK’s medical device regulatory body (the Medicines and Healthcare products Regulatory Agency (MHRA) determined that our histotripsy devices could be made available through an UCNA, highlighting the important public health value this device may provide for patients with primary or metastatic liver tumours.

The Edison System is the first and only platform to use histotripsy, a non-thermal, non-invasive focused ultrasound technology, to mechanically liquefy tumours without surgery, radiation, or systemic therapies. The device received U.S. Food and Drug Administration (FDA) De Novo clearance in October 2023. The HistoSonics platform uniquely enables physicians to plan, target, treat, and monitor tumour destruction with continuous real-time visualisation and control, offering unprecedented control and precision unmatched by any existing modality.

“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,” said Mike Blue, President and CEO, HistoSonics. “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.”

Following FDA De Novo clearance in October 2023, the Edison System has been adopted at major academic centers and hospitals across the US, including integrated health systems and community hospitals who are also eager to offer this breakthrough, non-invasive treatment to patients. Additional clinical trials are ongoing to expand the use of histotripsy to additional indications, including the non-invasive treatment of kidney tumours (HOPE4KIDNEY Trial NCT05820087) and pancreatic tumours (GANNON Trial NCT06282809) in advance of planned regulatory submissions for both indications.

The company believes strong clinical relationships within the UK, developed through multiple pioneering clinical trials conducted over previous years in both the liver and kidney, will help accelerate the adoption of histotripsy in major UK health centers.

As part of the UCNA authorization, HistoSonics will work with the MHRA to evaluate patient outcomes and regularly collect and analyse real-world data on device performance and safety as part of a post-market surveillance programme. HistoSonics is concurrently pursuing European regulatory approval via the European Conformity process (CE marking), which will enable broader commercial availability across the UK and Europe.

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, 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/.

“The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes” published in Annals of Surgery by Ziemlewicz, et.al. is licensed under CC BY-NC-ND.

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