HistoSonics has announced the enrollment of the first patients in its BOOMBOX master study, a prospective evaluation of histotripsy for the treatment of liver tumors. This post-market study will assess the real-world application of histotripsy, a novel, non-invasive therapy, across a diverse range of patients and clinical settings.
BOOMBOX Study Details
The BOOMBOX study is designed to enroll up to 5,000 patients, providing a comprehensive dataset for understanding the impact of histotripsy on liver tumors. The study will capture treatment data across various tumor types and disease stages, accommodating patients with varying interventional needs and clinical specialties. According to Amanda Cafaro, VP of Clinical Affairs at HistoSonics, the study's design will accelerate the company’s understanding of a wide range of research questions and expedite access to this innovative therapy.
Histotripsy Technology
HistoSonics' Edison system employs advanced imaging and proprietary sensing technology to deliver personalized, non-invasive treatments with precision. Histotripsy utilizes high-amplitude, short pulses of focused ultrasound to create a "bubble cloud" that mechanically destroys and liquefies targeted liver tumors. This approach offers a potential alternative to traditional treatments such as surgery, radiation, and chemotherapy.
Regulatory and Clinical Milestones
The Edison system received FDA investigational device exemption in February 2023, followed by the first kidney tumor treatment using histotripsy in March 2023. In the fall of the same year, the FDA granted de novo authorization for the Edison system.
Study Endpoints and Versatility
The primary endpoint of the BOOMBOX study is to examine histotripsy’s capability as a versatile tool. Subsequent sub-studies will evaluate additional endpoints to demonstrate increasingly specific treatment goals. According to Joe Herman, MD, VP of Medical Affairs at HistoSonics, the data captured will provide insights into how histotripsy may impact patients across many diseases and patient conditions, reinforcing the company's commitment to improving the lives of patients suffering from liver tumors.
