Clinical Research Results on Focused Ultrasound Therapy, the Technological Foundation of SONIRE Therapeutics, Published in “Ultrasound in Medicine & Biology”
SONIRE Therapeutics Inc. (Head Office: Chuo-ku, Tokyo; President & CEO: Tohru Satoh; hereinafter “the Company”) is pleased to announce that the results of clinical research on Sonodynamic Therapy (SDT) using High-Intensity Focused Ultrasound (HIFU), which serves as the technological foundation of our company, have been published in the academic journal Ultrasound in Medicine & Biology.
This paper summarizes the research results conducted prior to the Company’s establishment under a joint research framework led by Tokyo Women’s Medical University, Tohoku University, and Tokyo Medical University. The study was supported by the Medical Device Development Promotion Research Project of the Japan Agency for Medical Research and Development (AMED).
Paper Overview： Tile：First-in-Human Safety and Efficacy Study on Combination of High-Intensity Focused Ultrasound Sonication and Micellar Nanoparticle-Encapsulated Epirubicin, K-912: A Novel Sonodynamic Therapy for the Treatment of Refractory Abdominal Cancers. Journal：Ultrasound in Medicine & Biology URL：https://www.sciencedirect.com/science/article/abs/pii/S0301562925004193
Research Summary： This clinical study is the first-in-human clinical trial to evaluate the safety and efficacy of a new Sonodynamic Therapy (SDT) that combines a focused ultrasound therapy device equipped with a trigger pulse sequence and a specific drug (Epirubicin micelle/K-912). The study was conducted on a total of 12 cases, including unresectable pancreatic cancer (11 cases) and intrahepatic cholangiocarcinoma (1 case).
Future Outlook: The technology and treatment concepts established in this study were created primarily by the founding members of our company. We position this treatment method as one of the future prospects for the focused ultrasound therapy currently under development by the Company.
The Company will use the research results published this time as an important scientific foundation to promote research and development and collaboration with related institutions, aiming for the social implementation of focused ultrasound therapy.
Note: The Sonodynamic Therapy (SDT) reported in this paper is an unapproved treatment currently under development and is not yet approved for clinical or commercial use at this time.
SONIRE Therapeutics Co., Ltd. (Head Office: Chuo-ku, Tokyo; President & CEO: Tohru Satoh; hereinafter “the Company”) is pleased to announce that the results of its joint research with Tokyo University of Pharmacy and Life Sciences have been published in a peer-reviewed academic journal. This research was conducted in collaboration with Associate Professor Rui Tada of the Laboratory for Immunopharmacology of Microbial Products and Professor Yoichi Negishi of the Laboratory of Drug Delivery and Molecular Biopharmaceutics, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences.
In this study, Trigger HIFU for a small-animal model based on the same principle as SONIRE’s HIFU therapy system (development code: Suizenji) was used to evaluate the immune-stimulating effects of HIFU on tumors. Trigger HIFU was applied only to the right-side tumor in mice bearing tumors on both flanks, a significant suppression of tumor growth was also observed in the untreated left-side tumor. Detailed mechanistic analyses revealed an increase in tumor-infiltrating cytotoxic T cells, demonstrating that Trigger HIFU activates CD8+ T cell-dependent anti-tumor immunity and may exert systemic effects even on distant metastatic lesions.
SONIRE will continue to promote our business in order to realize the wish we put in our company name at the time of our foundation: “Sonics brings a hopeful new future to as many cancer patients and their families as possible.”
SONIRE Therapeutics Co., Ltd. (Head Office: Chuo-ku, Tokyo; President & CEO: Tohru Satoh; hereinafter “the Company”) is pleased to announce the establishment of its U.S. subsidiary, SONIRE Therapeutics Inc., effective September 1, 2025.
The U.S. subsidiary is located within the Japan Innovation Campus (JIC) in Palo Alto, California. JIC is a support hub founded under the initiative of Japan’s Ministry of Economy, Trade and Industry and Mori Building Co., Ltd., designed to assist Japanese startups in expanding their businesses in the United States.
Overview of U.S. Subsidiary Company Name : SONIRE Therapeutics Inc. Address : 214 Homer Ave, Palo Alto, CA 94301 (inside Japan Innovation Campus) Representative : Tohru Satoh
SONIRE will continue to promote our business in order to realize the wish we put in our company name at the time of our foundation: “Sonics brings a hopeful new future to as many cancer patients and their families as possible.”
SONIRE Therapeutics Inc. (Headquarters: Tokyo, Japan; President and CEO, Founder: Tohru Satoh; hereinafter referred to as “SONIRE”), announces that Mr. Tohru Satoh will be speaking at the Future of Therapy session of Pitch Event at MEDICA 2024, the world’s largest medical equipment trade fair, to be held in Düsseldorf, Germany from 11th to 14th November 2024. The title of the presentation will be “Cancer treatment using ultrasound technology”.
Date and time: November 13th (Wed) 12:45 – 12:55 (CET) (20:45 – 20:55 (JST)) Place: MEDICA INNOVATION FORUM (MIF) Hall 13 Booth E63
SONIRE will continue to promote our business in order to realize the wish we put in our company name at the time of our foundation: ” Sonics brings new future full of hope to as many cancer patients and their families as possible.”.
SONIRE Therapeutics Inc. (Headquarters: Tokyo, Japan; President and CEO, Founder: Tohru Satoh; hereinafter referred to as “SONIRE”), announces that the next-generation HIFU (High-Intensity Focused Ultrasound) therapy system (development code: Suizenji) developed by SONIRE has been designated as a breakthrough device by the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) for the treatment of pancreatic cancer.
The Breakthrough Device Program supports the development of medical devices that provide more effective treatment or diagnostic of life-threatening or irreversible human diseases.
Through this program, SONIRE will receive an opportunity to interact with FDA experts through different program options to efficiently address topics as SONIRE arises during premarket review phase. Therefore, it is expected that this program accelerates for patients to access the new treatment provided by Suizenji as soon as possible.
SONIRE will continue to promote our business in order to realize the wish we put in our company name at the time of our foundation: ” Sonics brings new future full of hope to many cancer patients and their families as possible.”.
SONIRE Therapeutics Inc. (Headquarters: Shinjuku-ku, Tokyo; President and CEO, Co-Founder: Tohru Satoh; hereinafter referred to as “SONIRE”), announces that NHK WOLRD’s “Medical Frontiers” will focus on HIFU therapy for pancreatic cancer, and the next-generation HIFU (High-Intensity Focused Ultrasound) therapy device, which has been developed by SONIRE, will be introduced in the program.
The program outline is as follows. Title : Destroying Pancreatic Cancer With Ultrasound Program Title : NHK World “Medical Frontiers” Broadcast date and time : January 8 (Mon) 23:30（JST） January 9 (Tue) 05:30（JST） [Rebroadcast] January 9 (Tue) 12:30（JST） [Rebroadcast] January 9 (Tue) 18:30（JST） [Rebroadcast] January 27 (Sat) 04:30（JST） [NHK BS1] Live streaming broadcast : You can watch the live streaming from the official website. https://www.nhk.or.jp/nhkworld/en/live/
SONIRE will continue to promote our business in order to realize the wish we put in our company name at the time of our foundation: ” Sonics（Ultrasound） Brings New Future to Cancer Patients and Families.”.
