Gunze Limited, based in Osaka, Japan, announced that its subsidiary, Gunze Medical Limited, has signed an exclusive distribution deal with HistoSonics, Inc. This medical tech company is located in Minneapolis, Minnesota. Gunze Medical now has exclusive rights to distribute HistoSonics’ noninvasive therapy. This platform uses their special histotripsy technology and will be available across Japan.
Gunze Medical will take charge of getting approval for manufacturing and marketing. They will also work on securing insurance coverage for the histotripsy-based ultrasound therapy devices in Japan. The company plans to create a strong support and training system with medical institutions. This will help ensure safe adoption and clinical excellence. The initiative seeks to lessen patient stress, boost treatment accuracy, and streamline workflows in healthcare settings.
Histotripsy is a groundbreaking, noninvasive method for treating tissue. It uses focused ultrasound energy to create tiny bubbles, known as “bubble clouds,” in the targeted tissue. The quick growth and shrinkage of these microbubbles break apart diseased cells. The body then clears them away naturally. Histotripsy is different from surgery or radiofrequency ablation (RFA). It causes very little damage to nearby healthy tissue and blood vessels. This makes it a great option for patients who can’t have invasive procedures.
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Histotripsy is now approved in Japan to treat liver tumors, like hepatocellular carcinoma and metastatic liver cancer. It is gaining global attention as a groundbreaking noninvasive cancer therapy. Researchers and clinicians anticipate that its applications will soon extend to other diseases such as kidney and pancreatic cancers and benign prostatic hyperplasia.
The HistoSonics platform got Breakthrough Device Designation from the FDA in 2021. It received formal market clearance in 2023. It’s already used at top university hospitals in the U.S. Over 2,000 treatments have been done so far. CE marking efforts are happening in Europe. At the same time, approvals are sought in Japan, South Korea, and Taiwan to increase access in Asia.
Gunze Medical and HistoSonics are joining forces to push noninvasive medical tech in Japan. This partnership helps patients and doctors move toward a future. In this future, ultrasound therapies might take the place of traditional surgeries.