by As reports from an acquisition by one of the leading players in the space of medical devices, Histosonics completed the registration for a crucial test to evaluate his Histotripsyplatform in the treatment of kidney tumors.
The prospective, multi-center, single-arm crucial #hope4kidney (NCT05820087) of the American company is designed to evaluate the effectiveness and safety of the Edison system for the destruction of kidney tissue by treating primary solid kidney tumors.
A total of 67 patients were registered with a single, non-metabetic fixed kidney mass ≤3cm. Patients are treated with the Edison system and followed five years after the procedure, with data at the 90-day evaluation point that must be submitted to support the approval of regulations at the US Food and Drug Administration (FDA).
The Edison system uses a technology called Histotripsy, in which non-thermal, non-invasive targeted ultrasonic waves are issued to focus on and focus and eliminate cancer-like liver tissue. The system received the NOVO approval from the US Food and Drug Administration (FDA) in 2023 and last month obtained its first major insurance coverage from a new health care policy from Healthcare Payor Blue Cross Blue Shield from Michigan (BCBSM) and Health Plan Option Blue Care Network.
The vision of Histosonics is that his Edison system becomes a “fundamental, non-invasive” solution in various clinical applications, explained the CEO of the company, Mike Blue.
“Completing the registration in our crucial kidney tumor study is an important milestone for that purpose and strengthens our confidence in expanding Histotripsy to extra tumor types and indications,” Blue said.
In May, Edison Histotripsy System has received controlled early limited market access in the UK under an unfulfilled clinical needs authorization (UCNA) under the UK’s Innovative Devices Access Pathway (IDAP) launched by the British government ‘in the Health Care system to help TRACK’ TRACK.
As reported for the first time by the Financial times Last month, Histosonics was looking for a rating of more than $ 2.5 billion for an acquisition of the company, with Medtronic, GE Healthcare and Johnson & Johnson (J&J), an old Backer of Histosonics, among the interested parties that evaluate the company. J&J recently participated in the $ 102m Series D finance round of Histosonics.
“Histosonics completes Pivotal Histotripsy System Trial registration” was originally made and published by Medical Device Network, a Global Data brand.
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