HistoSonics Moves to Advance Additional Histotripsy Applications Announcing FDA Submission for Kidney Tumors

HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced it 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 (renal) tumors.

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HistoSonics Edison® Histotripsy System

This milestone marks a significant step forward in the company’s mission to transform the treatment of solid tumors with a completely non-invasive technology that harnesses focused ultrasound to mechanically liquefy and destroy targeted tissue, reducing the risk of many complications and side effects associated with surgery, radiation, and other common therapies.

“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. “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.”

The submission is supported by clinical evidence from the ongoing #HOPE4KIDNEY Trial (NCT05820087), a prospective, multi-center, single-arm pivotal trial evaluating the safety and effectiveness of the Edison® System in destroying targeted kidney tumors. The trial enrolled 67 patients and continues to generate promising insights into the potential of histotripsy in kidney applications.

“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. 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,” said Dr. William Huang, Urologic Oncologist at NYU Langone Health and Principal Investigator for the #HOPE4KIDNEY Trial.

Kidney tumors represent a significant and growing clinical challenge, with approximately 680,000 people living with kidney tumors in the United States and an estimated 80,000 new cases will be diagnosed in 2026. Current standard-of-care treatments—such as partial nephrectomy and thermal ablation—are invasive and may carry risks including bleeding, infection, and unintended damage to surrounding tissue. Histotripsy offers a compelling new alternative: a non-invasive, non-thermal approach designed to precisely target tumors while helping to preserve critical kidney function.

Currently, the Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using histotripsy, a non-thermal, mechanical process of focused ultrasound. The system is currently being evaluated by the FDA for the destruction of kidney tumors, and its use in kidney applications remains investigational.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, MI, Minneapolis, MN and Madison, WI. For more information on the Edison Histotripsy System please visit: www.histosonics.com. For patient-related information please visit: www.myhistotripsy.com.

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