BOOMBOX, a post-market master study, evaluates the real-world use of histotripsy to treat liver tumors. Minneapolis-based HistoSonics expects the study to provide important data for up to 5,000 patients treated across multi-disciplinary providers.
HistoSonics said BOOMBOX represents a unique study in the medical device industry as it captures treatment data across diverse tumor types and disease stages in patients with varying interventional needs and amongst multiple clinical specialties. VP of Clinical Affairs Amanda Cafaro said the design can accelerate the company’s understanding of a wide range of research questions. Cafaro said it could expedite access to HistoSonics’ innovative therapy.
Edison, its image-guided therapy system, uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. Histotripsy, a novel form of focused ultrasound, uses high-amplitude, very short pulses to create a “bubble cloud.” That cloud mechanically destroys and liquefies targeted liver tumors. Histotripsy could offer an alternative to treatments like surgery, radiation and chemotherapy.
The system received FDA investigational device exemption in February 2023. A month later, HistoSonics announced the first kidney tumor treatment with its novel therapy system. Last fall, the FDA granted de novo authorization for the Edison system.
BOOMBOX has a primary endpoint examining histotripsy’s capability as a versatile tool. Subsequent sub-studies evaluate additional endpoints to demonstrate increasingly specific treatment goals.
“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.
