On May 1, 2026 Sonire Therapeutics, a U.S.-based clinical-stage medical device company, reported the initiation of its first U.S. clinical trial, SUNRISE-II, evaluating its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of pancreatic cancer.

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The SUNRISE-II trial is designed to assess the safety and feasibility of Sonire’s ultrasound-guided HIFU system in patients with pancreatic cancer. The effort represents a key milestone in the company’s U.S. clinical and regulatory strategy, building on prior development experience in Japan, and marks an important step toward advancing treatment options for one of the leading causes of cancer-related deaths in the United States.

"Treatment options for pancreatic cancer remain extremely limited due to the complexity and location of the disease," said Tohru Satoh, President and CEO of Sonire Therapeutics. "Initiating SUNRISE-II in the United States is a defining milestone for our company. It enables us to begin building clinical evidence in a new market while advancing a treatment approach designed to be less invasive and more accessible for patients."

In March 2026, the first patient treated using the HIFU system was by Pejman Ghanouni, MD, PhD, at Stanford Medicine. Ghanouni is the principal investigator of the SUNRISE-II clinical trial.

According to the American Cancer Society, pancreatic cancer’s five-year survival rate remains approximately 13 percent, significantly lower than many other major cancers. Sonire’s HIFU therapy system leverages real-time ultrasound guidance to enable precise, minimally invasive tumor ablation. The platform allows physicians to monitor treatment in real time while delivering targeted energy to the tumor site, without the need for general anesthesia. This approach has the potential to reduce procedural burden on patients and providers while expanding access to treatment in outpatient settings.

The SUNRISE-II trial reflects Sonire’s broader strategy to expand into the U.S. clinical development program and generate high-quality evidence to support future regulatory submissions and global commercialization. By initiating clinical development at leading institutions, the company aims to accelerate the adoption of a new, less invasive treatment option for patients with difficult-to-treat tumors.

To learn more about SUNRISE-II, visit View Source;viewType=Card&rank=1

(Press release, SONIRE Therapeutics, MAY 1, 2026, View Source [SID1234665012])