OSAKA, Japan– Gunze Limited (Tokyo: 3002) announced that its wholly owned subsidiary, Gunze Medical Limited, has entered into an exclusive distribution agreement with HistoSonics, Inc. of Minneapolis, Minnesota, for the company’s noninvasive ultrasound platform and proprietary sonic beam therapy using histotripsy technology.
Under the agreement, Gunze Medical will serve as the exclusive distributor in Japan for HistoSonics’ histotripsy-based therapeutic devices. The company plans to pursue manufacturing and marketing approval, secure insurance coverage, and establish a comprehensive support and training system in partnership with Japanese medical institutions. These efforts aim to reduce patient burden, enhance treatment precision, and improve efficiency and quality in clinical settings.
Histotripsy technology represents the world’s first noninvasive treatment method that uses focused ultrasound energy to generate microbubbles within targeted tissue. When these microbubbles rapidly expand and collapse, they mechanically disrupt and liquefy cancerous tissue, which the body then naturally eliminates. The technique offers a major advantage over conventional methods by minimizing damage to surrounding blood vessels and healthy tissue.
Traditional liver cancer treatments, such as surgery and radiofrequency ablation (RFA), can be unsuitable for many patients due to impaired liver function, tumor location, or advanced age. Histotripsy offers a new, noninvasive option that has gained significant attention in the United States and Europe. In Japan, it is currently approved for the treatment of liver tumors, including hepatocellular carcinoma and metastatic liver cancer, with potential future applications in kidney and pancreatic cancers as well as benign prostatic hyperplasia.
The HistoSonics platform received Breakthrough Device Designation from the U.S. Food and Drug Administration in 2021 and full market clearance in 2023. It is already in use at leading university hospitals across the United States, with more than 2,000 procedures completed to date. European CE marking is in progress, while expansion into Japan, South Korea, and Taiwan is planned as part of HistoSonics’ broader Asian market strategy.
The collaboration between Gunze Medical and HistoSonics marks a significant step toward bringing next-generation, noninvasive cancer treatment technologies to Japan’s healthcare system.
