SONIRE Therapeutics Inc. (hereinafter referred to as "SONIRE"), based in Tokyo, Japan, announces that its self-developed next-generation HIFU (High-Intensity Focused Ultrasound) therapy system (development code: Suizenji) has been designated as a breakthrough device by the U.S. Food and Drug Administration (hereinafter referred to as "the FDA") for the treatment of pancreatic cancer.

The FDA's Breakthrough Device Program supports the development of medical devices that provide more effective treatment or diagnostic of life-threatening or irreversible human diseases. Through the program, SONIRE will receive an opportunity to interact with FDA experts through different program options to efficiently address topics as they arise during a premarket review phase. Therefore, it is expected that the program will prompt patients to access the new treatment provided by Suizenji as soon as possible.