On June 1, 2026 Sonire Therapeutics, a U.S.-based clinical-stage medical device company, reported the completion of patient enrollment in SUNRISE-I, a randomized controlled trial evaluating the safety and efficacy of its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of pancreatic cancer.

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This multi-center study was conducted across seven leading clinical sites in Japan with a total of 90 patients with overall survival (OS) as the primary endpoint. The study represents one of the few randomized controlled trials (RCTs) conducted in the HIFU space for pancreatic cancer treatment, one of the most intractable cancers in the world today.

"Patients facing pancreatic cancer need treatment options that are less invasive, more accessible, and easier to integrate into real-world clinical practice," said Tohru Satoh, President and CEO of Sonire Therapeutics. "SUNRISE-I reflects our efforts to develop treatment approaches that reduce the burden on patients and address some of the limitations of existing treatment options. We believe the future of oncology will be shaped by therapies that are better suited to the needs of both patients and healthcare providers."

Sonire’s HIFU therapy system leverages real-time ultrasound guidance to deliver precise, non-invasive tumor ablation, allowing physicians to monitor treatment as it is administered without the need for general anesthesia. The approach is designed to reduce the procedural burden while expanding access to treatment in outpatient settings.

SUNRISE-I forms the basis of Sonire’s ongoing U.S.-based clinical development program, including SUNRISE-II, which is currently evaluating the company’s HIFU system in the United States. Together, these studies form a global clinical strategy aimed at advancing minimally invasive treatment options for pancreatic cancer.

Atsushi Sofuni, MD, Professor of Gastroenterology at Tokyo Medical University and physician who treated the first patient in the SUNRISE-I study, said, "Pancreatic cancer remains one of the most difficult cancers to treat, with a significant unmet medical need. HIFU therapy represents an innovative approach that is distinct from existing treatments. We hope the SUNRISE-I study will contribute to expanding future treatment options for patients with pancreatic cancer."

"The completion of enrollment in SUNRISE-I is a step forward for the broader field exploring ultrasound-based approaches for pancreatic cancer treatment and highlights the growing clinical interest in advancing new therapeutic options for patients," said Pejman Ghanouni, MD, PhD, Principal Investigator of Sonire Therapeutics’ U.S.-based SUNRISE-II study. Ghanouni is also a Professor of Radiology at Stanford Medicine.

By generating the clinical evidence from randomized, multi-center clinical trial with overall survival as a primary endpoint, Sonire aims to strengthen the body of data supporting the safety and efficacy of its HIFU platform and advance toward future regulatory submissions and global commercialization.

(Press release, SONIRE Therapeutics, JUN 1, 2026, View Source [SID1234666329])