HistoSonics

HistoSonics is a medical device company that develops non-invasive platforms utilizing histotripsy, a novel focused ultrasound therapy. The company's primary product is the Edison Histotripsy System, which received FDA De Novo clearance in October 2023 for the non-invasive destruction of liver tumors. Histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquefies targeted tissue at sub-cellular levels without damaging surrounding healthy tissue. The Edison System combines proprietary technology with advanced imaging to deliver personalized, non-invasive treatments with precision and control. It allows physicians to monitor tissue destruction in real-time, offering visualization and control not available with existing modalities. The system achieved a 95.5% technical success rate in clinical trials for precisely targeting and destroying liver tumors. HistoSonics is currently focused on commercializing the Edison System for liver treatments in the US and select global markets while exploring expanded applications for histotripsy in other organs such as the kidney, pancreas, and prostate.

Key customers and partnerships

HistoSonics has partnered with leading institutions across the US and internationally to develop multi-disciplinary histotripsy liver programs. The company conducted clinical trials at 13 sites across the US and Europe, including Mutua Terrassa Hospital and Vall D'Hebron Hospital in Barcelona, Spain. HistoSonics also maintains research collaborations with the University of Michigan, where histotripsy was originally developed, and the University of Wisconsin, which provides critical product development capabilities and validation of the company's non-invasive approach across multiple applications. In August 2024, HistoSonics announced plans to initiate the BOOMBOX Master Study to further evaluate the Edison System for liver tumor treatment across multidisciplinary users.