What You Should Know:
– HistoSonics , the developer and manufacturer of the Edison Histotripsy System, announced today they have been awarded an exclusive contract to provide Veteran’s Affairs hospitals across the United States access to their novel non-invasive tumor liquefying platforms.
– The contract, the work of the Veterans Health Administration (VHA) and the Strategic Acquisition Center (SAC) , establishes a $90 million ongoing schedule to develop histotripsy programs at key VA Hospitals. The announced VA contract is the culmination of a multi-year effort by HistoSonics, the company called Project Hero, to ensure meaningful value for Veterans and their families, VHA clinicians, administrators, and caregivers.
HistoSonics Advances Non-Invasive Tumor Treatment with FDA-Cleared Edison Histotripsy System
HistoSonics, a privately held medical device company, is pioneering non-invasive tumor treatment through its proprietary histotripsy technology—a focused ultrasound approach that mechanically destroys and liquefies targeted tissue. The company’s Edison Histotripsy System, now FDA “De Novo” cleared as of October 2023, is aimed at non-invasively treating liver tumors and is being integrated into major U.S. academic centers, community hospitals, and federal healthcare systems in partnership with FIDELIS Sustainability as an exclusive SDVOSB distributor to the Department of Defense and Veterans Affairs medical centers.
Technology Overview
Histotripsy represents a breakthrough in ultrasound therapy by delivering high-amplitude, ultra-short pulses that generate a “bubble cloud” to destroy and liquefy tumor tissue. This process, which occurs within microseconds, generates powerful mechanical forces that selectively break down cells without using heat, offering a non-thermal and non-invasive alternative to traditional surgery or radiation. HistoSonics’ system is typically performed in a single outpatient session, reducing risks such as infection and toxicity often associated with invasive treatments and enabling rapid recovery and resorption at the treatment site.
System Expansion and Future Applications
HistoSonics is actively commercializing the Edison Histotripsy System in the U.S. and the HistoSonics Histotripsy System in select global markets, focusing on liver treatments with plans to expand into additional organs like the kidney and pancreas. Headquartered in Ann Arbor, Michigan, with an office in Minneapolis, MN, the company’s approach is to extend the platform’s potential across a broad range of tumor types and clinical applications.
FDA Approval and Use Guidelines
The Edison System is authorized for the mechanical destruction of liver tumors, targeting partial or complete ablation of tumors that are otherwise unresectable. The FDA has not evaluated this system for specific cancer outcomes (such as local tumor progression or survival rates), and its use is restricted to trained physicians with HistoSonics certification. Comprehensive warnings, precautions, and trial data are included in the device’s Instructions for Use.
Through its innovative approach to focused ultrasound therapy, HistoSonics is transforming the landscape of tumor treatment, offering a promising non-invasive option for patients with liver tumors and charting a path for future histotripsy applications.
“We are pleased that Veterans suffering with tumors will soon have access to this innovative, non-invasive treatment at select VA facilities with interdisciplinary expertise,” said Patrick Malloy MD, Executive Director of the VHA National Radiology Program. Mark Wilson, MD, VHA National Director of Surgery, added, “Histotripsy is an innovative tool that will further enable VA specialists to continue to provide a full continuum of care to Veterans.”
