HistoSonics, the developer of the Edison® Histotripsy System, has announced the enrollment of the first patients in its novel BOOMBOX study, a prospective master protocol designed to assess the real-world application of histotripsy for treating liver tumors. This post-market study will collect data from up to 5,000 patients treated by a growing network of multidisciplinary histotripsy providers worldwide. BOOMBOX is a pioneering study in the medical device industry, capturing treatment data across various tumor types, disease stages, and patient needs, all under one comprehensive protocol.
“We designed this master protocol to streamline the research process and accelerate access to histotripsy for patients,” said Amanda Cafaro, VP of Clinical Affairs at HistoSonics. “Rather than requiring multiple individual protocols over years, BOOMBOX allows us to efficiently address a range of important clinical questions, speeding up patient access to this innovative therapy.”
The primary endpoint of the BOOMBOX study is to evaluate the versatility of histotripsy as a treatment tool. Subsequent substudies will focus on specific treatment goals, such as using histotripsy alone, in combination with other therapies, as a curative approach, or as a preparatory step for further treatments. Patient enrollment is underway at clinical centers in the United States, with plans to expand globally.
“Histotripsy offers a novel and effective treatment option for liver tumor patients, with an improved benefit-risk profile,” said Dr. Juan P. Rocca, Surgical Director of the Liver Cancer Program at NewYork-Presbyterian and Weill Cornell Medicine, one of the first centers offering histotripsy. “By participating in the BOOMBOX study, we are contributing to real-world research that will drive the future of this groundbreaking treatment.”
Dr. Joe Herman, VP of Medical Affairs at HistoSonics, added, “The BOOMBOX study will generate invaluable insights into the impact of histotripsy across a broad range of liver tumor cases. It reflects our commitment to advancing the understanding of how histotripsy can improve outcomes for patients suffering from liver tumors and related symptoms.”
The BOOMBOX study builds on the data from the landmark #HOPE4LIVER clinical trials, which supported the company’s New Drug Application to the U.S. FDA. In October 2023, the FDA granted de novo approval for the Edison System for non-invasive liver tumor destruction using histotripsy. In addition to BOOMBOX, HistoSonics has launched an ongoing investigator-sponsored research program to support independent studies and promote the safe and effective use of histotripsy.
The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including those that are inoperable. However, the FDA has not evaluated the system for the treatment of specific diseases or long-term outcomes such as survival rates. It should only be used by trained healthcare professionals and in accordance with clinical judgment.
About HistoSonics
HistoSonics is a privately held medical device company specializing in histotripsy, a non-invasive therapeutic platform that uses focused ultrasound to destroy and liquefy unwanted tissue. The company’s Edison® System is currently used in the U.S. and select international markets for the treatment of liver tumors, with plans to expand its use to other organs, including the kidney and pancreas. HistoSonics operates offices in Ann Arbor, Michigan, and Minneapolis, Minnesota.
