Amid reports of an acquisition by one of the leading players in the medical device space, HistoSonics’ Edison histotripsy system has been granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA).
The US company received the UCNA under the UK’s Innovative Devices Access Pathway (IDAP), launched by the UK Government in 2023 to help fast-track ‘transformative medical technologies’ into the healthcare system.
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Designed for the non-invasive destruction of liver tumours, the Edison system delivers focused ultrasound to target and eliminate cancerous liver tissue. The device received de novo clearance from the US Food and Drug Administration (FDA) in 2023.
HistoSonics’ president and CEO Mike Blue said the company was “honoured” to work alongside the National Health Service (NHS) to bring histotripsy to UK patients, many of whom have “limited options”.
He states: “Securing 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.”
HistoSonics’ authorisation comes as reports emerge that potential buyers are considering acquiring the company.
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By GlobalDataAccording to a 1 May report by the Financial Times, HistoSonics is seeking a valuation of more than $2.5bn, with Medtronic, GE HealthCare and Johnson & Johnson (J&J), a longtime backer of HistoSonics, among the interested parties evaluating the business.
J&J most recently participated in the company’s $102m Series D funding round.
HistoSonics was selected for a UCNA under the IDAP programme after the UK Medicines and Healthcare products Regulatory Agency (MHRA) determined that histotripsy devices may provide “public health value” for patients with primary or metastatic liver tumours.
Other companies awarded part of a £10m funding package from the MHRA last year to expedite their medical devices’ entry onto the UK market included Upfront Diagnostics for a portable blood test, and Lenus Health for an AI-based tool to predict patients’ risk of hospitalisation for chronic obstructive pulmonary disease (COPD).
Earlier this month, healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network became the first US medical insurer to cover non-thermal histotripsy using HistoSonics’ Edison system.
