Sonire Therapeutics announced it has raised $18 million in a Series A financing round to advance its high-intensity focused ultrasound (HIFU) therapy for pancreatic cancer and expand clinical development efforts in the United States. The round was led by Santé Ventures, with participation from Fast Track Initiative (FTI), Nomura SPARX Investment (Japan Growth Capital Investment Corporation), SBI Investment, and other Japanese investors.
The funding will support completion of the SUNRISE-I randomized controlled trial in Japan, accelerate U.S. clinical programs, and advance regulatory and commercialization efforts following the company’s 2024 FDA Breakthrough Device Designation.
Sonire is developing a non-invasive HIFU therapy system that integrates real-time imaging guidance with proprietary technologies such as noise cancellation, cavitation bubble visualization, and a robot-assisted positioning platform. The system also features rapid multi-focus scanning capabilities designed to enable precise thermal ablation of tumors.
Unlike conventional ultrasound-guided HIFU systems, Sonire’s platform provides clear real-time visualization of the treatment area and does not require anesthesia. The procedure can be performed in an outpatient setting in approximately 20 minutes and requires only one physician, reducing both cost and operational burden for healthcare providers.
Pancreatic cancer remains one of the deadliest cancers, with a five-year survival rate of approximately 12%. Current treatment options are limited, and there is no widely established standard for local therapy. Sonire’s approach aims to improve overall survival when used in combination with chemotherapy, while offering a less invasive alternative to surgery and radiation.
Earlier research using a prototype HIFU system demonstrated a 66% disease control rate in patients with advanced or refractory pancreatic and biliary tract cancers in a sonodynamic therapy setting. These findings informed the development of Sonire’s current system. The ongoing SUNRISE-I study is evaluating HIFU combined with chemotherapy versus chemotherapy alone across seven hospitals in Japan. The company currently holds 25 issued patents and 22 pending.
Founded in February 2020 in Tokyo and now headquartered in Palo Alto, California, Sonire Therapeutics is focused on developing patient-friendly, non-invasive cancer treatments using advanced acoustic engineering.
KEY QUOTES:
“We are grateful for the strong support from our investors, which validates the transformative potential of our sonic technology. 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.”
Tohru Satoh, President and CEO, Sonire Therapeutics
“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. 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.”
Dennis McWilliams, Managing Director, Santé
“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.”
Koji Yasuda, Principal, Fast Track Initiative (FTI)
