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Sonire Therapeutics KK
Realization of Manufacturing for a Next-Generation Ultrasound Therapeutic Device, Domestic Regulatory Approval, and U.S. Market Expansion

As of April, 2026

City Year of Establishment Founder
Chuo-ku, Tokyo 2020 Tohru Satoh
Jun Okamoto
Shin Yoshizawa
Partner VC Latest round of Fundraising Valuation
— Series C Non-Disclosure

Program name

Deep-Tech Startups Support Program

Research theme

Realization of Manufacturing for a Next-Generation Ultrasound Therapeutic Device, Domestic Regulatory Approval, and U.S. Market Expansion

Business Plan

This project aims to develop and manufacture a minimally invasive HIFU-based therapeutic device for pancreatic cancer and other indications, obtain regulatory approval in Japan, and advance clinical development in the U.S. toward global expansion.

By integrating proprietary cavitation-based visualization technology, the device enables safe treatment under real-time monitoring and supports scalable manufacturing to accelerate clinical adoption.

Research Outline

In this R&D initiative, we will develop a next-generation HIFU device that advances conventional ultrasound-guided approaches by incorporating a novel cavitation-based focal visualization technology.

Through the following PoC milestones, we aim to obtain regulatory approval for difficult-to-treat cancers and enable global deployment:

  1. Clinical data acquisition for pancreatic cancer treatment in Japan
  2. Safety and efficacy evaluation through exploratory clinical studies in the U.S.
  3. Design transfer to mass production and establishment of consumables manufacturing processes
Phase Business Area/Field Research Period Research Grant Amount
DMP Healthcare 2026-2027FY JPY 1,999 million

International collaborative technology demonstration

Countries/Regions Collaborative activity outline
United States Expansion
  • - Local base establishment
We will build a clinical development framework in the U.S. to accelerate the global adoption of therapies for difficult-to-treat cancers.
In the U.S., we will conduct an exploratory clinical study (SUNRISE-II) of a next-generation HIFU device for pancreatic cancer, complete patient enrollment, and evaluate its safety and efficacy.

Last Updated : October 5, 2026