HistoSonics’ Edison Histotripsy System Earns CE Mark

HistoSonics revealed that it has secured CE mark approval in Europe for its Edison non-invasive histotripsy system.

The Edison system is a noninvasive, image-guided platform that uses proprietary focused ultrasound (histotripsy) to liquefy and destroy liver tumors in a single treatment, avoiding surgery and radiation while potentially reducing side effects. Edison obtained Taiwanese Food and Drug Administration approval in May.

The approval was supported by the #HOPE4LIVER pivotal trial, which enrolled patients across the U.S. and Europe and achieved a 90% local tumor control rate at 12 months with few complications. Researchers continue to collect long-term follow-up data.

“Receiving CE mark approval marks another historic milestone for HistoSonics and for patients across Europe,” Mike Blue, chairman and CEO of HistoSonics told the press. “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.

The Edison histotripsy system gained FDA de novo clearance in October 2023. HistoSonics said it expects to begin its phased commercial rollout in Europe shortly.

“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 non-invasive treatment option, and especially for patients currently suffering from the tumors in their liver and who have very few if any options,” said Blue.

The recent closing of a financial round led by Reed Jobs, Yosemite, and several new investors valued HistoSonics at $3.75 billion.