Key Points
- HistoSonics’ Edison histotripsy system has been granted a CE Mark for the treatment of liver tumors.
- The company plans to initiate a phased commercial rollout in Europe, beginning with select centers of excellence.
HistoSonics recently announced that its Edison™ histotripsy system has been granted the CE Mark in Europe for the treatment of liver tumors. The Edison platform uses this form of focused ultrasound to noninvasively and mechanically destroy tissue in the liver.
The approval was based on clinical data from the #HOPE4LIVER pivotal trial, which enrolled patients across the United States and Europe. After 12 months of follow up, participants experienced a 90% rate of local tumor control across all treated tumors regardless of tumor type or origin. Overall survival at one year was 73.3% for patients with primary liver cancer, and 48.6% for patients with metastatic disease.
“Receiving CE Mark approval marks another historic milestone for HistoSonics and for patients across Europe,” said Mike Blue, HistoSonics chairman and CEO. “Histotripsy represents a fundamentally new way to treat patients, using focused ultrasound to mechanically destroy tumors and tissue without the invasiveness or toxicity of traditional procedures. With the Edison System now approved in Europe, we look forward to working with leading clinical centers throughout the EU and UK to expand access to this noninvasive treatment option, and especially for patients currently suffering from the tumors in their liver and who have very few if any options.”
HistoSonics plans to initiate a phased commercial rollout of the Edison system in Europe, beginning with select centers of excellence that specialize in liver tumor treatment.
In October 2023, Edison was granted US Food and Drug Administration (FDA) clearance to treat liver tumors, marking the first time the use of histotripsy earned regulatory approval worldwide. In August 2025, the company was acquired by a group of globally recognized private and public investors, valuing the company at $2.25 billion.
HistoSonics is investigating additional indications, including benign prostatic hyperplasia, kidney tumors, and pancreatic cancer.
Read HistoSonics’ Press Release
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