Sonire Therapeutics has raised $18m towards supporting the ongoing clinical advancement of its non-invasive thermal ablation tumour treatment system.
The Tokyo, Japan-headquartered company’s Series A financing round was led by Santé Ventures, with additional participation from investors including Fast Track Initiative (FTI), Nomura SPARX Investment, and SBI Investment.
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Sonire’s Suizenji high-intensity focused ultrasound (HIFU) platform combines real-time imaging guidance with a robot-assisted positioning platform for the thermal ablation of cancerous tumours. The platform obtained a breakthrough device designation from the US Food and Drug Administration (FDA) in November 2024 and is currently under evaluation in the randomised control SUNRISE-I trial (NCT05601323) in patients with unresectable pancreatic cancer.
Comparing HIFU with chemotherapy versus chemotherapy alone, SUNRISE-I has enrolled patients from seven Japanese hospitals. Prior to this study, an academic-led study of Suizenji 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 (SDT) setting.
Sonire CEO, Tohru Satoh, commented: “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 US clinical and regulatory milestones.”
Non-invasive pancreatic cancer treatment modalities
HIFU represents just one of the emergent non-invasive treatment modalities for pancreatic cancer treatment. In February 2026, Novocure’s Optune Pax device for locally advanced pancreatic cancer treatment obtained FDA clearance, becoming the first clearance by the agency in this indication since Eli Lilly’s Gemzar (gemcitabine) chemotherapy drug in 1996.
Indicated for concomitant use alongside gemcitabine and nab-paclitaxel, Optune Pax delivers tumour-treating electric fields (TTFields) via arrays worn on the abdomen. These target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival.
Optune Pax’s approval was supported by data from the randomised Phase III PANOVA-3 trial (NCT03377491) that evaluated the safety and efficacy of TTFields in combination with gemcitabine and nab-paclitaxel (gem/nab-pac) versus the chemotherapy drugs alone.
The study followed 571 patients for a minimum of 18 months and met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS). Data indicated that 285 patients in the TTFields-gem/nab-pac arm had mOS of 16.2 months, compared to 14.2 months among 286 patients treated with gem/nab-pac alone – reflecting a statistically significant two-month improvement.
