HistoSonics seeks FDA authorization to expand focused ultrasound system to kidney tumors

HistoSonics has submitted a De Novo request to the U.S. Food and Drug Administration seeking authorization to expand the use of its Edison Histotripsy System to include the destruction of kidney tumors, the company announced.

The company said the filing marks a step toward broadening the use of histotripsy, a non-invasive focused ultrasound technology designed to mechanically liquefy and destroy targeted tissue without surgery, radiation or thermal energy.

The Edison System is currently indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using histotripsy. Its use for kidney tumors remains investigational while under FDA review.

“This submission is an important milestone in expanding histotripsy beyond the liver and into the kidney, an area where patients and physicians are seeking organ-preserving and nephron-sparing alternatives,” said Mike Blue, chairman and CEO of HistoSonics, in a statement.

Blue said the company believes histotripsy could “fundamentally change” how solid tumors are treated by delivering precise, non-invasive therapy while helping preserve patient quality of life.

The submission is supported by data from the ongoing #HOPE4KIDNEY Trial, a prospective, multicenter, single-arm pivotal study evaluating the safety and effectiveness of the Edison System in destroying targeted kidney tumors. According to the company, the trial enrolled 67 patients.

William Huang, a urologic oncologist at NYU Langone Health and principal investigator for the trial, said researchers observed “precise, noninvasive tumor destruction without incisions, radiation, or thermal injury.”

“These findings highlight the potential of histotripsy to expand treatment options for patients with kidney tumors and represent an important step forward for both physicians and patients,” Huang said in a statement.

HistoSonics said kidney tumors represent a growing clinical challenge in the United States, with about 680,000 people currently living with kidney tumors and an estimated 80,000 new cases expected to be diagnosed in 2026.

Current standard treatments, including partial nephrectomy and thermal ablation, can be invasive and may carry risks such as bleeding, infection and damage to surrounding tissue, the company said. Histotripsy is designed as a non-thermal alternative intended to precisely target tumors while preserving kidney function.

Privately held HistoSonics is developing a platform based on histotripsy, which uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. In addition to liver and kidney applications, the company said it is exploring potential uses in organs including the pancreas and prostate.