FDA Deems SONIRE's HIFU Therapy a Breakthrough Device

SONIRE Therapeutics Inc., a Tokyo-based company, announced on October 16, 2024, that its advanced HIFU (High-Intensity Focused Ultrasound) therapy system, codenamed Suizenji, has been granted breakthrough device designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

The FDA's Breakthrough Device Program aims to accelerate the development of medical devices that offer significant advantages in treating or diagnosing life-threatening or irreversibly debilitating diseases. This designation will enable SONIRE to engage closely with FDA experts through various program pathways, facilitating a more streamlined premarket review process. As a result, patients are expected to gain quicker access to the innovative treatment provided by Suizenji.

SONIRE remains committed to advancing its business objectives to fulfill the vision behind its establishment: to leverage sonic technology to bring hope and a better future to numerous cancer patients and their families.