1st Patients Enrolled in HistoSonics’ BOOMBOX Master Study

HistoSonics has enrolled the first patients in its BOOMBOX prospective master protocol study. The study will evaluate real-world use of histotripsy to treat liver tumors.

The company’s Edison system provides non-invasive, mechanical liver tumor destruction, including partial or complete destruction of unresectable liver tumors via histotripsy.

The study, according to HistoSonics, will offer important data for up to 5,000 patients treated among a global base of multi-disciplinary histotripsy providers. The master study’s design will capture treatment data across diverse tumor types and disease stages in patients with differing interventional needs, among multiple clinical specialties.

BOOMBOX’s primary endpoint will assess histotripsy’s capability as a versatile tool. Subsequent sub-studies will evaluate other endpoints to show specific treatment goals: as a monotherapy, a combination therapy, for curative intent as well as priming for additional treatments.

The study begins HistoSonics’ post-market evidence generation efforts in the liver after a recent publication of its pivotal #HOPE4LIVER trials was submitted to the U.S. Food and Drug Administration (FDA) as part of the company’s market access submission, which led to an FDA de novo grant in October 2023.

“Traditionally, this complexity would require multiple individual study protocols over a prolonged period of time, delaying access to histotripsy for patients in need,” said Amanda Cafaro, VP of Clinical Affairs, HistoSonics. “We designed this post-market master protocol study and its accompanying sub-studies to accelerate our understanding of a wide range of clinically relevant research questions, expediting access to this innovative therapy.”

“The depth and breadth of data we will capture as part of the BOOMBOX study will provide us and our histotripsy program partners with insight on how histotripsy may impact patients across many diseases and patient conditions. BOOMBOX is our long-term commitment to learning how histotripsy can best improve the lives of patients suffering from liver tumors and the debilitating symptoms these patients face,” said Joe Herman, MD, VP of Medical Affairs, HistoSonics.