Sonire Therapeutics

The company was established by three founders: Tohru Satoh serves as President and CEO, bringing experience from Ono Pharmaceutical and Oncolys Biopharma. Dr. Jun Okamoto, the Vice President and COO, has a background in developing surgical assistance robots. Dr. Shin Yoshizawa, the Chief Technology Officer, is a professor at Tohoku University's Graduate School of Engineering with expertise in medical ultrasound and fluid engineering.

SONIRE's core product is the 'Suizenji' system, an ultrasound-guided HIFU device designed for non-invasive cancer treatment. The technology delivers focused ultrasound energy from outside the body to heat and destroy cancerous tissue, eliminating the need for skin incisions and reducing the risks associated with radiation exposure. A key feature is its use of cavitation bubbles to enhance the heating effect, which allows for quicker treatment times and visualizes the treatment area on ultrasound imaging for improved accuracy. The system also incorporates a robotic guidance system for high-precision positioning.

The company's initial focus is on treating unresectable pancreatic cancer, a disease with limited effective treatment options. In October 2024, the U.S. Food and Drug Administration (FDA) granted the Suizenji system a Breakthrough Device Designation, a move expected to expedite its path to clinical use. The company is conducting a multicenter, randomized clinical trial in Japan and received Investigational Device Exemption (IDE) approval in August 2025 to begin clinical trials in the United States. Sonire's business model involves developing this proprietary medical device and navigating the regulatory approval process for commercialization, targeting healthcare professionals in oncology and non-invasive surgery. The company has secured significant funding through multiple rounds, raising a total of approximately JPY 3.1 billion by November 2022 from investors including Fast Track Initiative, SBI Investment, and JA Mitsui Leasing.