Sonire Therapeutics, a clinical-stage medical device company, has announced the completion of an $18 million Series A financing round to advance its high-intensity focused ultrasound (HIFU) technology for the treatment of pancreatic cancer. The round was led by Santé Ventures, with participation from Fast Track Initiative (FTI), Nomura SPARX Investment, and SBI Investment.
The company’s proprietary HIFU system is designed for the non-invasive thermal ablation of solid tumors, initially targeting pancreatic cancer—a disease associated with a five-year survival rate of approximately 12% and limited local treatment options. Sonire’s device previously received FDA Breakthrough Device Designation in 2024, reflecting its potential to address a significant unmet clinical need.
Sonire’s approach introduces several operational and clinical differences compared to conventional ultrasound-guided HIFU systems. Its platform incorporates patented noise-cancellation and cavitation bubble visualization technologies, enabling real-time imaging of the treatment site. The procedure can be performed in an outpatient setting in approximately 20 minutes, requires no anesthesia, and is administered by a single physician, reducing both staffing requirements and procedural complexity.
The system also leverages robot-assisted delivery and advanced multi-focus scanning to support precise targeting and ablation of tumor tissue. These features are intended to improve workflow efficiency while maintaining treatment accuracy, particularly in complex anatomical regions such as the pancreas.
Proceeds from the financing will be used to support the ongoing SUNRISE-I randomized controlled trial in Japan, which is evaluating the combination of HIFU therapy with chemotherapy in pancreatic cancer patients. The study represents a first-of-its-kind clinical effort in this indication. Earlier exploratory research using a prototype system demonstrated a 66% disease control rate among patients with advanced pancreatic and biliary tract cancers.
Sonire has built a portfolio of 25 issued patents supporting its technology and is expanding its operational presence from Tokyo to a new headquarters in Palo Alto, California. This expansion aligns with the company’s plans to pursue U.S.-based clinical development and regulatory pathways.
“Our goal is to deliver a new standard of care that gives patients more time and better quality of life,” said Tohru Satoh, President and CEO of Sonire Therapeutics.
Click here for the original news story.