Osaka-Gunze Limited (Headquarters: Osaka, Japan; President: Toshiyasu Saguchi) [TOKYO:3002] is pleased to announce that its wholly owned subsidiary, Gunze Medical Limited (Headquarters: Osaka, Japan; President: Shojiro Matsuda) and HistoSonics, Inc. (Headquarters: Minneapolis, MN USA; CEO: Mike Blue) have entered into an agreement to exclusively distribute a noninvasive platform and proprietary sonic beam therapy utilizing the histotripsy technology.
Under this agreement, Gunze Medical will assume exclusive distribution responsibility in Japan for non-invasive ultrasound therapy devices equipped with Histotripsy technology developed by HistoSonics. Moving forward, the company will work to obtain manufacturing and marketing approval and insurance coverage in Japan, while also establishing a support and training system in collaboration with medical institutions. This will contribute to reducing the physical burden on patients through more accurate treatment and improving efficiency and quality in medical settings.
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Gunze Medical and HistoSonics Enter into Exclusive Distributor Agreement in Japan for Noninvasive Platform and Proprietary Sonic Beam Therapy Using Histotripsy Technology
About noninvasive histotripsy platform
This medical device uses histotripsy technology, the world's first noninvasive treatment method that utilizes microbubbles generated by ultrasound. Histotripsy is a novel technology that uses ultrasound energy to physically disrupt cancerous tissue without the need for surgical intervention. Focusing ultrasound at a single point creates a cluster of microbubbles called a "bubble cloud" within water-rich tissue. The rapid expansion and collapse of this bubble cloud precisely and selectively destroys and liquefies cancerous tissue. The destroyed cells are then excreted from the body as waste. A major advantage is the minimal damage to surrounding blood vessels and healthy tissue.
Conventional treatments for liver cancer, such as surgery and radiofrequency ablation (RFA), have been the mainstream approaches. However, many patients have difficulty undergoing treatment due to factors such as impaired liver function, tumor location, complications, or advanced age. Histotripsy is gaining attention in Europe and the United States as a groundbreaking technology that offers a new treatment option for these patients.
In Japan, histotripsy is currently approved to treat liver tumors, including hepatocellular carcinoma and metastatic liver cancer. However, it is expected to be used in the future to treat a wide range of diseases, including kidney and pancreatic cancers and benign prostatic hyperplasia.
The Histotripsy platform received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2021 and obtained formal market clearance in 2023. It has already been introduced at renowned university hospitals in the US and has accumulated over 2,000 treatment cases. In Europe, efforts are underway to obtain CE marking. In Asia, approval is planned for Japan, South Korea and Taiwan.
Histotripsy Platform developed by HistoSonics (Image courtesy of HistoSonics)
About Gunze Medical Limited
Gunze Medical was founded in 1986 in Osaka, Japan. It is a wholly owned subsidiary of Gunze. Its product lines are sales of medical devices (plastic and reconstructive surgery, neurosurgery, oral surgery, cardiovascular surgery, cosmetic surgery, pediatric surgery, dermatology, etc.) and consulting for opening medical facilities. Gunze Medical delivers a better future for patients by providing innovative "Biomaterials x Devices".
About HistoSonics, Inc.
HistoSonics is a privately held medical device company developing a noninvasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify 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, and others.
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