- HistoSonics has received FDA approval to begin a #HOPE4KIDNEY clinical trial in the US to treat primary renal tumors.
- The company’s Edison platform uses histotripsy to noninvasively and mechanically destroy tissue.
- This new trial comes on the heels of the #HOPE4LIVER studies, which have completed enrollment.
The US Food and Drug Administration (FDA) has approved HistoSonics to begin a kidney tumor clinical trial in the US. The study will be called #HOPE4KIDNEY.
The clinical trial will evaluate the safety and efficacy of HistoSonics’ Edison platform – a sonic beam therapy platform using histotripsy – to target and destroy primary renal tumors.
Participant enrollment for the clinical trial is expected to begin in the second half of 2023 at up to 15 sites in the US.
This trial comes after the company submitted results of their #HOPE4LIVER trials, which were conducted in the US and Europe. The initial analyses indicate the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors using histotripsy.
“We are excited to expand on our experiences in successfully targeting and treating in the liver using our enhanced Edison platform that combines advanced imaging and targeting capabilities with real-time treatment monitoring,” said Mike Blue, president and CEO of HistoSonics, in a press release. “The kidney is a logical next application, as treating in the kidney has very similar procedural and anatomical considerations as the liver, and Edison was specifically designed to treat anywhere in the abdomen, as a starting point.”
The Edison platform was granted Breakthrough Device Designation by the FDA in October 2021. The Breakthrough Devices Program was established to allow fast-tracking of novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.