SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach
Palo Alto, CA – May 1, 2026 – Sonire Therapeutics, a U.S.-based clinical-stage medical device company, today announced the initiation of its first U.S. clinical trial, SUNRISE-II, evaluating its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of pancreatic cancer.
The SUNRISE-II trial is designed to assess the safety and feasibility of Sonire’s ultrasound-guided HIFU system in approximately 10 patients with pancreatic cancer. The effort represents a key milestone in the company’s U.S. clinical and regulatory strategy, building on prior development experience in Japan, and marks an important step toward advancing treatment options for one of the leading causes of cancer-related deaths in the United States.
“Treatment options for pancreatic cancer remain extremely limited due to the complexity and location of the disease,” said Tohru Satoh, President and CEO of Sonire Therapeutics. “Initiating SUNRISE-II in the United States is a defining milestone for our company. It enables us to begin building clinical evidence in a new market while advancing a treatment approach designed to be less invasive and more accessible for patients.”
In March 2026, the first patient treated using the HIFU system was by Pejman Ghanouni, MD, PhD, at Stanford Medicine. Ghanouni is the principal investigator of the SUNRISE-II clinical trial.
According to the American Cancer Society, pancreatic cancer’s five-year survival rate remains approximately 13 percent, significantly lower than many other major cancers. Sonire’s HIFU therapy system leverages real-time ultrasound guidance to enable precise, minimally invasive tumor ablation. The platform allows physicians to monitor treatment in real time while delivering targeted energy to the tumor site, without the need for general anesthesia. This approach has the potential to reduce procedural burden on patients and providers while expanding access to treatment in outpatient settings.
The SUNRISE-II trial reflects Sonire’s broader strategy to expand into the U.S. clinical development program and generate high-quality evidence to support future regulatory submissions and global commercialization. By initiating clinical development at leading institutions, the company aims to accelerate the adoption of a new, less invasive treatment option for patients with difficult-to-treat tumors.
About Sonire Therapeutics Sonire Therapeutics Inc. is a clinical-stage medical device company pioneering sonic technology to treat cancer in a way that is not only more effective but less invasive for patients. The company’s next-generation HIFU therapy system is designed to provide precise, non-invasive, outpatient treatment for solid tumors, beginning with pancreatic cancer. Founded in February 2020 in Tokyo and now headquartered in Palo Alto, CA, Sonire is committed to transforming oncology through innovative, patient-centered acoustic engineering. For more information, visit www.sonire-therapeutics.com.
Sonire Therapeutics Closes $18 Million Series A Financing to Advance Breakthrough HIFU Therapy for Pancreatic Cancer, Expands U.S. Clinical Development
Led by Santé, the funding will support completion of the world’s first randomized HIFU trial for pancreatic cancer, and accelerate U.S. clinical programs for the company’s anesthesia-free, outpatient sonic therapy
Palo Alto, CA – April 15, 2026 – Sonire Therapeutics, a U.S. based clinical-stage medical device company, today announced $18M in Series A financing. The round was led by Santé Ventures with participation from Fast Track Initiative (FTI), Nomura SPARX Investment (Japan Growth Capital Investment Corporation), and SBI Investment, as well as other Japanese investors. The proceeds will accelerate clinical development, support U.S. regulatory progress following the company’s 2024 FDA Breakthrough Device Designation, and advance global commercialization efforts for its innovative non-invasive cancer treatment.
Sonire’s proprietary High-Intensity Focused Ultrasound (HIFU) therapy system combines real-time imaging guidance with patented technologies, including a noise-cancellation system, cavitation bubble visualization, and a robot-assisted positioning platform, along with advanced capabilities such as rapid multi-focus scanning, to enable precise, effective thermal ablation of tumors. Unlike conventional ultrasound-guided HIFU systems, Sonire’s solution provides clear real-time visualization of the treatment site, requires no anesthesia, and can be performed on an outpatient basis in approximately 20 minutes. Additionally, this system requires only one physician to administer treatment, which lowers the cost and staff burden for hospitals.
“We are grateful for the strong support from our investors, which validates the transformative potential of our sonic technology,” said Tohru Satoh, President and CEO of Sonire Therapeutics. “This funding enables us to complete our landmark SUNRISE-I randomized controlled trial in Japan, which will be the world’s first of its kind for HIFU in pancreatic cancer, while preparing for U.S. clinical and regulatory milestones. Our goal is to deliver a new standard of care that gives patients more time and better quality of life, without the burdens of invasive procedures or anesthesia.”
Pancreatic cancer remains one of the most lethal diseases, with a 5-year survival rate of only 12%. Existing treatments are limited, and to date, there is the still high unmet medical needs due to a lack of established standard local therapy options. Sonire’s approach is designed to prolong overall survival when combined with chemotherapy while offering a safer, more patient-friendly alternative to surgery or radiation.
Foundational work from an academic-led study using a prototype HIFU system (MoonShot-2) demonstrated a 66% disease control rate in patients with advanced or refractory pancreatic and biliary tract cancers in a sonodynamic therapy (SDT) setting. These findings have informed the development of Sonire’s current system. The SUNRISE-I study (HIFU with chemotherapy vs. chemotherapy alone) is ongoing across seven leading Japanese hospitals with Sonire’s current system. The company holds 25 issued patents and 22 pending.
“Sonire has engineered a genuine leap forward in next generation HIFU by solving the core challenges of visualization, precision, and workflow that so far have limited the field,” noted Dennis McWilliams, Managing Director for Santé. “Santé is excited to lead this round to expand Sonire’s corporate footprint to the United States and build upon their solid clinical foundation in Japan.”
“Sonire’s differentiated approach is well positioned to bring meaningful benefit to patients globally. We look forward to continuing our support of the team as they advance U.S. clinical development” noted Koji Yasuda, Principal at Fast Track Initiative (FTI)
About Sonire Therapeutics Sonire Therapeutics Inc. is a clinical-stage medical device company pioneering sonic technology to treat cancer in a way that is not only more effective but less invasive for patients. The company’s next-generation HIFU therapy system is designed to provide precise, non-invasive, outpatient treatment for solid tumors, beginning with pancreatic cancer. Founded in February 2020 in Tokyo and now headquartered in Palo Alto, CA, Sonire is committed to transforming oncology through innovative, patient-centered acoustic engineering. For more information, visit www.sonire-therapeutics.com/en.
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.”.
