Sonire Therapeutics has initiated its first US clinical trial, SUNRISE-II, to evaluate its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of pancreatic cancer, one of the deadliest forms of cancer globally.

The SUNRISE-II trial is designed to assess the safety and feasibility of the company’s ultrasound-guided HIFU platform in patients with pancreatic cancer. The development marks a significant milestone in Sonire’s clinical and regulatory strategy in the US, building on its prior experience in Japan and advancing its efforts to bring innovative treatment options to a wider patient population.

The first patient in the trial was treated in March 2026 at Stanford Medicine by Principal Investigator Pejman Ghanouni, signalling the start of clinical evaluation in a leading research institution.

Pancreatic cancer continues to present major treatment challenges due to its complex nature and late diagnosis, with the American Cancer Society estimating a five-year survival rate of just around 13 percent. Current treatment options remain limited, highlighting the need for more effective and less invasive therapies.

Sonire’s HIFU system uses real-time ultrasound imaging to precisely target and ablate tumours without the need for incisions or general anesthesia. The technology allows physicians to monitor treatment as it is delivered, potentially reducing procedural risks and enabling treatment in outpatient settings. This minimally invasive approach is expected to improve patient comfort while expanding access to care.

The SUNRISE-II trial forms part of the company’s broader strategy to establish a strong clinical evidence base in the US and support future regulatory submissions and global commercialisation. By conducting trials at leading institutions, Sonire aims to accelerate the adoption of its innovative HIFU technology and offer a new therapeutic option for patients with difficult-to-treat cancers.