HistoSonics Receives CE Mark for Edison Histotripsy System

HistoSonics has received CE Mark approval for its Edison System, enabling commercialization of the company’s non-invasive histotripsy technology across Europe and other markets that recognize the CE Mark. The approval follows an increasing number of regulatory clearances and was supported by a growing body of clinical evidence demonstrating the safety and effectiveness of histotripsy for the treatment of liver tumors.

The Edison System is a non-invasive, image-guided platform intended for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. It uses focused ultrasound to mechanically liquefy and destroy unwanted tissue and tumors in a single procedure without the need for invasive surgery or radiation, with potentially fewer side effects than traditional therapies. Clinical studies evaluating the system have demonstrated the ability to precisely target and destroy liver tumors while maintaining a favorable safety profile and avoiding many of the complications associated with conventional thermal ablation or surgical approaches.

The CE Mark approval was based in part on clinical data from the #HOPE4LIVER pivotal trial, which enrolled patients across the United States and Europe, including hospitals in Germany, Italy, Spain, and the United Kingdom. The trial demonstrated a 90% local tumor control rate at 12 months across tumor types treated, with a low complication rate. Additional long-term follow-up data are currently being collected to further validate these outcomes in broader real-world use.

Liver tumors remain a significant global health challenge, with many patients not candidates for surgery or traditional ablation procedures due to tumor location, underlying liver disease, or other clinical factors. Histotripsy offers a potential new treatment option that can precisely target tumors while minimizing damage to surrounding healthy tissue. The Edison System received FDA De Novo clearance in October 2023.

Mike Blue, Chairman and Chief Executive Officer of HistoSonics, said receiving CE Mark approval marks another historic milestone for the company and for patients across Europe. He noted that 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, he added that the company looks forward to working with leading clinical centers throughout the EU and UK to expand access to this non-invasive treatment option, especially for patients currently suffering from liver tumors 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 specializing in liver tumor treatment. The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors using histotripsy. The device is not approved for the treatment of any specific disease, including cancer, nor have regulatory agencies assessed outcomes such as local tumor control, five-year survival, or overall survival.