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.