HistoSonics Receives CE Mark, Unlocking Access Across Europe and Accelerating Global Commercialization of the Edison® Histotripsy Platform

HistoSonics, today announced that the company has received CE Mark approval in Europe for its Edison® System, enabling commercialization of the company’s non-invasive histotripsy technology in Europe and other markets that recognize the CE Mark.

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The Edison System is a novel, non-invasive, image guided platform that is intended for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. It uses the mechanical properties of focused ultrasound, called histotripsy, to liquefy and destroy unwanted tissue and tumors in a single procedure without the need for invasive procedures or radiation, and with potentially fewer side effects than traditional therapies.

CE Mark 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. Clinical studies evaluating the Edison 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 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 months¹ across tumor types treated, with a low complication rate. Additional long-term follow-up are currently being collected to further validate these outcomes in broader real-world use.

“Receiving CE Mark approval marks another historic milestone for HistoSonics and for patients across Europe,” said Mike Blue, Chairman and Chief Executive Officer, HistoSonics. “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 non-invasive treatment option, and especially for patients currently suffering from the tumors in their liver and who have very few if any options.”

Liver tumors remain a significant global health challenge. Many patients are 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 Histotripsy System received FDA De Novo clearance in October 2023.

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.

The device should only be used by physicians who have completed HistoSonics-provided training, and its use should be guided by the clinical judgment of a qualified and appropriately trained physician. For complete warnings, precautions, and clinical trial results, please refer to the device’s Instructions for Use.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, MI, Minneapolis, MN and Madison, WI. For more information on the Edison Histotripsy System please visit: www.histosonics.com. For patient-related information please visit: www.myhistotripsy.com.

References:

¹ The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes published in Annals of Surgery by Ziemlewicz, et.al. is licensed under CC BY-NC-ND.

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