FDA Greenlights HistoSonics' Groundbreaking Edison® Histotripsy System

HistoSonics®, the developer behind the Edison® System and innovative histotripsy therapy platforms, proudly announces the FDA's approval for its groundbreaking "Breakthrough" platform. This milestone is the result of the FDA's De Novo Classification Request process, a rigorous review pathway designed for medical devices without prior predicates. As a result, Edison now stands as the exclusive histotripsy platform accessible in the United States.

The success of histotripsy was clearly demonstrated through a comprehensive analysis of data, which involved the evaluation of 44 subjects for safety and 44 treated tumors for efficacy. Notably, the subjects presented a diverse range, including 18 with hepatocellular carcinoma (HCC) tumors and 26 with metastatic tumors in the liver originating from various primary sources, such as the colon, rectum, breast, and others. There were only three instances of procedure-related adverse events of CTCAE Grade 3 or higher observed within 30 days post-histotripsy, translating to a complication rate of 6.8%. Importantly, these events were consistent with those typically associated with focal liver therapies and not unique to histotripsy.

This achievement represents a significant step forward for patients poised to benefit from the distinctive advantages of histotripsy, and it underscores the commendable efficiency of the FDA throughout the review process.

Histotripsy is rooted in the use of focused sound energy for controlled acoustic cavitation, effectively destroying targeted liver tissue, including tumors, at the sub-cellular level. HistoSonics' Edison System employs proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with unparalleled precision and control. The company believes that the novel mechanism of action of their proprietary technology offers substantial benefits to patients, including the ability of the treatment site to recover and resorb rapidly.

Histotripsy promises to have a meaningful impact on patients grappling with unresectable liver diseases, including liver tumors. The future holds exciting possibilities for the evolving role of histotripsy in treatment strategies.


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