FDA Grants Breakthrough Device Designation for Emerging High-Intensity Focused Ultrasound Treatment of Pancreatic Cancer

The Food and Drug Administration (FDA) has issued a breakthrough device designation to Sonire Therapeutics for the use of its high-intensity focused ultrasound (HIFU) system (Suizenji) to treat pancreatic cancer, a disease that may claim the lives of 51,750 people in the United States in 2024, according to estimates from the American Cancer Society.^1,2

Through the use of cavitation ultrasound, Sonire Therapeutics said the Suizenji HIFU system facilitates the delivery of thermal therapy with lower acoustic energy in addition to providing image clarity for targeted treatment.³

The high-intensity focused ultrasound (HIFU) system Suizenji (Sonire Therapeutics) has garnered the FDA's breakthrough device designation for pancreatic cancer treatment. The HIFU system is currently being evaluated in a phase 2 trial for the treatment of patients with unresectable pancreatic cancer refractory or intolerant to initial chemotherapy. (Image courtesy of Sonire Therapeutics.)

“These are key features to achieve both safety and treatment throughput in our system,” noted Tohru Satoh, the chief executive officer of Sonire Therapeutics, in a 2023 interview.³

Researchers are currently comparing adjunctive use of the emerging HIFU system with second-line chemotherapy versus chemotherapy alone in a phase 2 trial for the treatment of patients with unresectable pancreatic cancer refractory or intolerant to initial chemotherapy, according to Sonire Therapeutics.

References

1. Sonire Therapeutics. Sonire’s HIFU therapy system designated as breakthrough device by FDA. PR Newswire. Available at: https://www.prnewswire.com/news-releases/sonires-hifu-therapy-system-designated-as-breakthrough-device-by-fda-302277187.html . Published October 16, 2024. Accessed October 16, 2024.

2. American Cancer Society. Key statistics for pancreatic cancer. Available at: https://www.cancer.org/cancer/types/pancreatic-cancer/about/key-statistics.html#:~:text=The%20average%20lifetime%20risk%20of,Cancer%20Survival%20Rates%20by%20Stage. . Accessed October 16, 2024.

3. Focused Ultrasound Foundation. Company profile: Sonfire Therapeutics. Available at: https://www.fusfoundation.org/posts/company-profile-sonire-therapeutics/#:~:text=We%20spoke%20with%20the%20SONIRE's,what%20makes%20their%20device%20unique. . Published February 22, 2023. Accessed October 16, 2024.