HistoSonics is expanding its presence in Asia by leveraging TFDA approval to accelerate regional adoption and broaden clinical evidence and training.

The company is pursuing De Novo FDA clearance to extend the Edison system to kidney tumors, supported by the HOPE4KIDNEY trial which enrolled 67 patients and completed enrollment in mid-2025, underscoring nephron-sparing potential.

TFDA awarded approval for the Edison Histotripsy System in Taiwan, marking a pivotal milestone in Asia-focused growth and global expansion.

Edison is currently indicated for non-invasive destruction of liver tumors and is being evaluated for kidney, pancreas, prostate, and other sites as part of ongoing expansion.

National Taiwan University Hospital treated a range of tumors — including liver, kidney, pancreatic cancers, and sarcoma — under research protocols, signaling broad early clinical exploration of histotripsy.

Histotripsy operates via mechanical cavitation from focused ultrasound to liquefy targeted tissue without heat, suggesting potential for outpatient treatment and quick recovery.

NTUH’s ongoing clinical leadership is highlighted as a central driver of HistoSonics’ regional strategy and future applications.

In the US, the Edison system has De Novo clearance since 2023 for liver tumors, becoming the first histotripsy platform in the country with about 90% tumor control in one-year data.

TFDA’s review of the clinical and regulatory package was thorough, culminating in unanimous committee support for approval.

CEO Mike Blue framed the TFDA approval as validation of strong clinical evidence, regulatory rigor, and histotripsy’s potential as a non-invasive therapy platform.

NTUH was the first installation site in Taiwan, where physicians quickly adopted histotripsy under research protocols, reflecting rapid clinical uptake.

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