As reports of an acquisition by one of the leading players in the medical device space percolate, HistoSonics has completed enrolment in a pivotal trial to evaluate its histotripsy platform in treating kidney tumours.
The US company’s prospective, multi-centre, single-arm pivotal #HOPE4KIDNEY (NCT05820087) trial is designed to evaluate the effectiveness and safety of the Edison system for the destruction of kidney tissue by treating primary solid renal tumours.
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A total of 67 patients have been enrolled with a single, non-metastatic solid kidney mass ≤3cm. Patients will be treated with the Edison system and followed for five years post-procedure, with data at the 90-day evaluation point to be submitted in support of regulatory approval with the US Food and Drug Administration (FDA).
The Edison system uses a technology called histotripsy, involving the delivery of non-thermal, non-invasive focused ultrasound waves to target and eliminate cancerous liver tissue. The system received de novo clearance from the US Food and Drug Administration (FDA) in 2023 and last month secured its first major insurance coverage from a new healthcare policy from Healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network.
HistoSonics’ vision is for its Edison system to become a “foundational, non-invasive” solution across a range of clinical applications, the company’s CEO, Mike Blue stated.
“Completing enrolment in our pivotal kidney tumour trial represents a significant milestone toward that goal and reinforces our confidence in expanding histotripsy into additional tumour types and indications,” said Blue.
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By GlobalDataIn May, Edison histotripsy system has been granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (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.
As first reported by the Financial Times last month, HistoSonics is seeking a valuation of more than $2.5bn for a takeover of the company, 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 HistoSonics’ $102m Series D funding round.
