Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

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.

To learn more about SUNRISE-II, visit https://clinicaltrials.gov/study/NCT07033689?term=NCT07033689&viewType=Card&rank=1

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’s HIFU therapy system has been designated as a Breakthrough Device by FDA

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.

For more information about the Breakthrough Device Program, please refer to the FDA website.
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

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.”.

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Announcement of First Patient Enrolled in a Randomized Phase 2 study of SONIRE’s Novel HIFU Therapy System for Unresectable Pancreatic Cancer Patients in Japan

SONIRE Therapeutics Inc. (Headquarters: Shinjuku-ku, Tokyo; President and CEO: Tohru Satoh; hereinafter referred to as “SONIRE”), announces that a randomized phase 2 study for the treatment of unresectable pancreatic cancer with SONIRE’s next-generation High-Intensity Focused Ultrasound (HIFU) therapy system (development code: Suizenji) has been commenced.

The 5-year survival rate of pancreatic cancer is very low at 8.5%*, and the number of deaths in Japan in 2020 was estimated to be 37,677 patients*, ranking fourth after lung cancer, colorectal cancer, and stomach cancer, and increasing every year. In addition, treatment options for pancreatic cancer are limited, and there is a strong need for innovative treatment modalities.

In this clinical trial, the efficacy of Suizenji in combination with second-line chemotherapy will be evaluated in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy, with overall survival as the primary endpoint (Expected Enrollment 90 participants).

Details of the study can be found on the following website

Japan Registry of Clinical Trials (https://jrct.niph.go.jp/en-latest-detail/jRCT2032220428)

ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT05601323?term=NCT05601323&draw=2&rank=1)

SONIRE was established in February, 2020 to develop a next-generation ultrasound-guided HIFU therapy system by utilizing the technology and clinical know-how established by Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected to become a new treatment modality for cancer because it is minimally invasive, less burdensome to the body, and can be performed repeatedly without radiation exposure. SONIRE is developing the HIFU therapy system as a new treatment modality for pancreatic cancer, which is one of the most difficult-to-treat cancers.

*. Data from the National Cancer Center Cancer Information Service, Statistical Information by Cancer Type, Pancreatic (updated on October 05, 2022)

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SONIRE Therapeutics Announces JPY2.35 billion Series B Financing

SONIRE Therapeutics Inc. (Head Office: Shinjuku-ku, Tokyo. President and CEO: Tohru Satoh) announced today that it has raised JPY2.35 billion in Series B financing through a third-party allotment to existing shareholders and new investors for a randomized controlled trial and commercialization of the next-generation HIFU (High-Intensity Focused Ultrasound) system (development code: Suizenji) for the treatment of unresectable pancreatic cancer. This brings the total amount raised by SONIRE to approximately JPY3.1 billion.

List of investors in this round (in no particular order)

New investor：NISSAY CAPITAL CO., LTD.,  Japan Growth Capital Investment Corporation, Daiwa Corporate Investment Co.,Ltd., Resona Capital Co., Ltd., Carbon Ventures Co., Ltd. / QR Investment Co., Ltd., JA MITSUI LEASING, LTD.

Existing Shareholders：Fast Track Initiative, Inc., SBI Investment Co., Ltd., Mitsubishi UFJ Capital Co., Ltd., FFG Venture Business Partners Co., Ltd., Higin Capital Co., Ltd.

【Comment from Mr. Tohru Satoh, President and CEO of SONIRE Therapeutics Inc.】
I am deeply grateful to all the investors who supported us again in this round after supporting Series A last year, and to the new investors who joined this funding round out of their belief in our vision. The funding raised in this round will be allocated to expanding our business, including pancreatic cancer clinical trials in Japan and overseas expansion. Our vision at SONIRE is to bring a new future to cancer patients using sonic technology, and we will spare no effort in making that vision a reality as soon as we possibly can.

【Comment from Dr. Hiroko Kimura of Fast Track Initiative, Inc. 】
We made an additional investment in this round after investing in Series A last year. Since its establishment, SONIRE has, in pursuit of its vision, made definitive progress in laying the groundwork for device development and clinical development. Going forward, they will move ahead with building their operations in preparation for clinical trials, approval and sale. We sincerely anticipate that this revolutionary medical device, developed in Japan, will be used to treat patients all over the world. As a venture capital firm striving for Capital For Life, Fast Track Initiative will continue to support SONIRE.

【Comment from Mr. Junichi Imoto of NISSAY CAPITAL CO., LTD.】
We have invested in SONIRE because the HIFU treatment device they are developing has the potential to provide a new treatment option for patients with intractable cancers. We are happy to join CEO Satoh and his team of specialists as they continue to break new ground. By making this revolutionary technology available for the treatment of pancreatic cancer and other intractable cancers as quickly as possible, we expect that they will make a major contribution to society.

【Comment from Mr. Ichitaro Akita of Nomura SPARX Investment, Inc.※】
NSPI looks forward to SONIRE achieving medium-term growth as it allocates capital efficiently to establish HIFU as a treatment for intractable pancreatic cancer globally, as well as using HIFU therapy in the treatment of other types of cancers.

(※ Nomura SPARX Investment, Inc. is an asset management company of Japan Growth Capital Investment Corporation.)

About SONIRE Therapeutics Inc.
SONIRE was established in February 2020 to develop the next-generation HIFU (High-Intensity Focused Ultrasound) system using the technology and clinical know-how has been built by Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University over the past years. HIFU therapy is expected as a new cancer treatment because it is non-invasive and no radiation risk, so patients can receive the treatment repeatedly. SONIRE has developed the HIFU therapy system as a new treatment modality targeting at intractable cancers like pancreatic cancer. You can see details through our homepage below.

/https://www.sonire-therapeutics.com/en/

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