SUNRISE-I
DesignMulticenter randomized studyPopulationUnresectable pancreatic cancerTarget90 participantsPrimary endpointOverall survivalStatusEnrollment completion announced in March 2026
Clinical development
Evidence across
two markets.
SONIRE is advancing its HIFU platform for pancreatic cancer through clinical programs in Japan and the United States.
Two programs
SUNRISE-I + SUNRISE-II.
Instead of scattering trial updates across news releases, the redesigned clinical page puts the core study structure in one place.
SUNRISE-I
SUNRISE-II
Clinical milestones
From Japan study to U.S. entry.
The timeline is designed as a clear progression, making regulatory and clinical momentum visible without turning the page into a press-release archive.
2023
SUNRISE-I begins in Japan
A randomized study is initiated for unresectable pancreatic cancer using the Suizenji platform.
2024
FDA Breakthrough Device Designation
SONIRE’s next-generation HIFU system receives Breakthrough Device designation for pancreatic cancer.
2025
Palo Alto presence established
SONIRE establishes its U.S. subsidiary inside the Japan Innovation Campus in Palo Alto.
2026
SUNRISE-I enrollment completed
SONIRE announces completion of the 90-patient enrollment target in Japan.
2026
SUNRISE-II initiated
The company begins its first U.S. clinical study of ultrasound-guided HIFU therapy for pancreatic cancer.
Regulatory + clinical science
Built from engineering, medicine and regulatory know-how.
SONIRE says the platform draws on more than a decade of technology, clinical know-how and regulatory science developed at Tokyo Women’s Medical University, Tohoku University and Tokyo Medical University.
Company originsContinue
The clinical story starts with the people behind the technology.
Explore SONIRE’s origins, leadership, collaborators and international footprint.