Non-dilutive funding will support the commercialization, development, and expansion strategy for Sonire's Ultrasound-Guided HIFU Platform

Sonire Therapeutics, a U.S.-based clinical-stage medical device company pioneering non-invasive ultrasound therapies for cancer treatment, today announced that Sonire Therapeutics KK, the firm's Japan-based group company, has been selected for the New Energy and Industrial Technology Development Organization's (NEDO) Deep-Tech Startups Support Program, which is one of Japan's largest government-backed initiatives focused on accelerating the commercialization of breakthrough technologies.

Through NEDO, Sonire has been awarded approximately $13 million in non-dilutive funding to support the advancement of its proprietary High-Intensity Focused Ultrasound (HIFU) therapy platform. The funding will support manufacturing scale-up, regulatory approval activities in Japan, expansion into additional clinical indications, and acceleration of the company's ongoing U.S. clinical development efforts.

The award reflects the strength of Sonire's underlying technology and global commercialization strategy, supporting the company's efforts from research and development through commercialization in both Japan and the U.S. The NEDO program is designed to support promising deep technology companies, and help them bridge the gap between development and commercialization. This provides critical support across the full pathway from product development and regulatory approval through manufacturing and market adoption.

"We are honored to have been selected for NEDO's DTSU." said Tohru Satoh, President and CEO of Sonire Therapeutics. "At Sonire, we are committed to advancing new treatment options for patients with pancreatic cancer and other difficult-to-treat diseases through our ultrasound therapy platform. This funding will help accelerate our clinical development, regulatory activities, manufacturing readiness, and commercialization efforts in both Japan and the United States, bringing us closer to making this technology available to patients worldwide."

Sonire's next-generation 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 procedural burden while expanding access to pancreatic cancer treatment in outpatient settings, addressing a significant unmet need in a disease where five-year survival remains approximately 13 percent.

The NEDO award follows significant recent momentum for the company, including the initiation of the SUNRISE-II clinical trial in the U.S., $18 million in Series A financing, and the completion of patient enrollment in SUNRISE-I, a randomized controlled trial evaluating the safety and feasibility of Sonire's HIFU system for pancreatic cancer in Japan. Sonire previously advanced through the STS and PCA phases of the NEDO DTSU Program. The DMP phase represents the program's most advanced commercialization stage, supporting manufacturing readiness and market preparation activities.

By supporting activities that span development, regulatory approval, manufacturing, and commercialization, the program positions Sonire to accelerate the global adoption of its ultrasound-guided HIFU technology and expand access to minimally-invasive treatment options for patients facing difficult-to-treat cancers.