08.19.2025 – SONIRE Therapeutics (Headquarters: Tokyo, Japan; President and CEO: Tohru Satoh) received approval from the U.S. Food and Drug Administration on August 1, 2025 for its Investigational Device Exemption (IDE).With this approval, clinical trials for unresectable pancreatic cancer in the United States can now be conducted.
SONIRE develops next-generation high-intensity focused ultrasound (HIFU) systems for oncology, with an initial focus on unresectable pancreatic cancer, where treatment options remain limited. The IDE authorizes a U.S. clinical study of Suizenji, its ultrasound-guided HIFU device, in patients with unresectable pancreatic cancer.
FTI continues to be committed to the success of SONIRE through supporting its strategy development, implementation, and external collaborations as the company advances HIFU as a new treatment option in oncology.
Other related news: https://us.fasttrackinitiative.com/sonire-therapeutics-receives-fda-breakthrough-device-designation-for-hifu-pancreatic-cancer-treatment/
About SONIRE Therapeutics: SONIRE was established in February 2020 to develop the next-generation High-Intensity Focused Ultrasound (HIFU) system using the technology and clinical know-how has been built by Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected as a new cancer treatment because it is non-invasive with no risk of radiation, so patients can receive the treatment repeatedly. SONIRE has developed the HIFU therapy system as a new treatment modality targeting intractable cancers such as pancreatic cancer. Visit our homepage here: https://www.sonire-therapeutics.com/en/
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