Edison Histotripsy System submitted to FDA for kidney tumor indication

HistoSonics has submitted a de novo request to the FDA seeking authorization to expand the indication for its Edison Histotripsy System to include destruction of renal tumors, according to a company announcement.¹

The Edison system is already FDA authorized for noninvasive destruction of liver tumors using histotripsy, a focused ultrasound technology that mechanically liquifies and destroys targeted tissue. The kidney application remains investigational. If authorized in this indication, the system would represent a new noninvasive option for select patients with renal masses, aiming to preserve kidney function.

“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 the company release.¹ “We believe histotripsy has the potential to fundamentally change how solid tumors are treated, delivering precise, non-invasive therapy that preserves what matters most—including patient quality of life.”

Study of the Edison Histotripsy System

The de novo submission is supported by data from the prospective, multicenter, single-arm pivotal #HOPE4KIDNEY study (NCT05820087), which is evaluating the use of focused ultrasound–based histotripsy in patients with primary solid renal tumors.² The study enrolled 67 patients with nonmetastatic solid renal masses measuring 3 cm or smaller as confirmed by imaging or biopsy.³ Participants were enrolled through clinical trial sites across the US.

Related: Pivotal trial of histotripsy system for kidney tumors reaches enrollment goal

All patients underwent the histotripsy procedure and will be followed longitudinally for up to 5 years, although the primary analysis submitted to regulators is based on 90-day data.²

Eligibility criteria for the study included biopsy-confirmed renal tumors, ECOG performance status of 0 to 2, and the ability to tolerate general anesthesia. Patients with bilateral kidney tumors, solitary kidneys, hereditary renal cancer syndromes, or tumors overlapping critical structures were excluded.

“Histotripsy represents a fundamentally novel approach to treating kidney tumors. In the #HOPE4KIDNEY Trial, we observed precise, noninvasive tumor destruction without incisions, radiation, or thermal injury,” said principal investigator William C. Huang, MD, urologic oncologist at NYU Langone Health, in the new release.¹ “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.”

Final completion of the trial is expected in July 2030.

REFERENCES

1. HistoSonics moves to advance additional histotripsy applications announcing FDA submission for kidney tumors. News release. HistoSonics, Inc. May 11, 2026. Accessed May 11, 2026. https://www.businesswire.com/news/home/20260511268688/en/HistoSonics-Moves-to-Advance-Additional-Histotripsy-Applications-Announcing-FDA-Submission-for-Kidney-Tumors

2. The HistoSonics Edison™ System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY) (#HOPE4KIDNEY). ClinicalTrials.gov. December 22, 2025. Accessed May 11, 2026. https://clinicaltrials.gov/study/NCT05820087

3. HistoSonics completes enrollment in #HOPE4KIDNEY trial evaluating non-invasive histotripsy to treat kidney tumors. News release. HistoSonics, Inc. June 6, 2025. Accessed May 11, 2026. https://www.businesswire.com/news/home/20250606659747/en/HistoSonics-Completes-Enrollment-in-HOPE4KIDNEY-Trial-Evaluating-Non-Invasive-Histotripsy-to-Treat-Kidney-Tumors