Sonire Therapeutics, a U.S.-based clinical-stage medical device company, 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 commercialisation 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 visualisation, and a robot-assisted positioning platform, along with advanced capabilities such as rapid multi-focus scanning, to enable precise, effective thermal ablation of tumours. Unlike conventional ultrasound-guided HIFU systems, Sonire's solution provides clear real-time visualisation of the treatment site, requires no anaesthesia, 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 randomised 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 anaesthesia."
Pancreatic cancer remains one of the most lethal diseases, with a 5-year survival rate of only 12 per cent. Existing treatments are limited, and to date, there are 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.
