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 Announces Publication of Joint Research Results with Tokyo University of Pharmacy and Life Sciences

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.

Publication Details
Title: Cavitation bubble-assisted high-intensity focused ultrasound induces abscopal immune responses
Journal: International Immunopharmacology
Article URL: https://www.sciencedirect.com/science/article/pii/S1567576925015565

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.”

Announcement of Establishment of U.S. Subsidiary

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.”

Selected for the Olympus Asia Pacific Innovation Program

SONIRE Therapeutics Inc. (Headquarters: Shinjuku-ku, Tokyo; President and CEO: Tohru Satoh; hereinafter referred to as “SONIRE”), announces that it has been selected for the Olympus Asia Pacific Innovation Program (OAIP), which is organized by Olympus Corporation in cooperation with MedTech Innovator Asia Pacific.

The OAIP is open to startup companies with innovative technologies that contribute to minimally invasive treatments and lesion detection, diagnosis, and treatment in the medical device field and the grand prize winner will receive a mentorship program and reward from Olympus. The OAIP winners will also be selected as one of the MedTech Innovator Asia Pacific 2023 Cohort, which will be hosted by MedTech Innovator Asia Pacific, and will be provided with various support and opportunities to participate in the pitch. For more information, please see the news release regarding the MedTech Innovator Asia Pacific 2023 Cohort.

https://www.businesswire.com/news/home/20230606006132/en/MedTech-Innovator-Asia-Pacific-Names-24-Startups-to-Annual-Accelerator

We 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.”.

Shin Yoshizawa, our CTO, has been promoted to Professor at Tohoku University (Graduate School of Engineering)