HistoSonics has received a CE mark for its Edison Histotripsy System, clearing the way for the company to sell the cancer treatment in Europe. The Edison system delivers pulsed sound waves to destroy tumors, and it’s initially indicated for liver tumors.
The company plans to expand the use of the Edison histotripsy system to other tumor types. HistoSonics received de novo authorization in 2023 to sell the device in the U.S. for the treatment of liver cancer.
How the Edison System Works
The Edison system uses pulsed sound waves to cause bubbles to quickly form and collapse, destroying tissue. By using real-time imaging to guide delivery of the sound waves, physicians can destroy tumors without harming healthy tissue.
Unlike other anticancer techniques, HistoSonics’ noninvasive approach destroys tumors without incisions, radiation, or thermal injury. They received a CE mark for the system based on results from a clinical trial, which enrolled patients in the U.S. and Europe.
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The trial reported a 90% local tumor control rate 12 months after treatment. The Edison system is intended for the noninvasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors using histotripsy.
Expansion Plans
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,” Blue said in a statement.
The company’s phased commercial rollout will initially target centers of excellence specializing in liver tumor treatment. Physicians must complete training provided by HistoSonics before using the Edison system.
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.
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Current Trials
HistoSonics started a trial of Edison in patients with benign prostatic hyperplasia in March. The company is working to expand into kidney cancer in the U.S. while starting a phased commercial rollout of Edison at European liver cancer centers, supported by a $250 million funding round.
As HistoSonics moves forward with its expansion plans, the company’s noninvasive approach to cancer treatment may provide new options for patients with limited alternatives. The Edison system’s ability to destroy tumors without harming healthy tissue is a key benefit of this technology.
HistoSonics’ receipt of the CE mark is a significant step forward for the company, and it’s likely to have a positive impact on the lives of patients with liver cancer in Europe. The company’s commitment to expanding access to this noninvasive treatment option is a notable development in the field of cancer treatment.