Dive Brief:
- HistoSonics said Monday it received a CE mark for its Edison Histotripsy System, clearing the company to sell the cancer treatment in Europe.
- The Edison system delivers pulsed sound waves to destroy tumors. HistoSonics received de novo authorization in 2023 to sell the device in the U.S. for the treatment of liver cancer.
- Supported by a $250 million funding round, HistoSonics is working to expand into kidney cancer in the U.S. while starting a phased commercial rollout of Edison at European liver cancer centers.
Dive Insight:
The pulsed sound waves Edison delivers cause bubbles to quickly form and collapse, destroying tissue. By using real-time imaging to guide delivery of the sound waves, physicians seek to destroy tumors without harming healthy tissue. Unlike other anticancer techniques, HistoSonics’ noninvasive approach destroys tumors without incisions, radiation or thermal injury.
HistoSonics received a CE mark for the system based on results from a pivotal liver cancer clinical trial, which enrolled patients in the U.S. and Europe, including in Germany, Italy, Spain and the U.K. The company reported a 90% local tumor control rate 12 months after treatment.
Edison is intended for the noninvasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors using histotripsy.
HistoSonics CEO Mike Blue outlined the implications of receiving the CE mark.
“With the Edison System now approved in Europe, we look forward to working with leading clinical centers throughout the EU and U.K. 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,” Blue said in a statement.
HistoSonics’ phased commercial rollout will initially target centers of excellence specializing in liver tumor treatment. Physicians must complete training provided by HistoSonics before using Edison.
Launching the device in Europe will continue HistoSonics’ efforts to expand the use of the system. In May, the company said it applied for U.S. de novo authorization of Edison for the treatment of kidney tumors. HistoSonics started a trial of Edison in patients with benign prostatic hyperplasia in March.
