Key Points
- SONIRE Therapeutics’ focused ultrasound system uses cavitation bubbles that increase the heating efficiency and visualization in treating pancreatic cancer.
- The FDA’s Breakthrough Devices Program allows fast-tracking of certain novel devices and expedites patient access to treatments.
Focused Ultrasound company SONIRE Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its next-generation high-intensity focused ultrasound (HIFU) therapy system (development code : Suizenji) for the treatment of pancreatic cancer.
Pancreatic cancer is notoriously challenging to treat, and, according to the National Cancer Institute, the five-year survival rate is only about 12%.
SONIRE’s Suizenji system was developed based on a device used in a clinical study for pancreatic cancer in Japan in 2017. It uses cavitation bubbles that increase the heating efficiency, enabling effective thermal therapy with lower acoustic energy. The bubbles also aid in visualizing the treatment area on ultrasound imaging.
Last year, the company launched a multicenter, randomized clinical trial for unresectable pancreatic cancer in Japan. The trial is assessing whether participants who receive HIFU therapy in addition to chemotherapy experience prolonged survival when compared with participants who receive chemotherapy alone.
The Breakthrough Devices Program was established by the FDA in 2018 to fast-track novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process,” explains Jessica Foley, PhD, the Foundation’s chief scientific officer and managing director of government affairs. “The goal is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval.”
Five other focused ultrasound companies have earned Breakthrough Device Designation for their products: HistoSonics for its EdisonTM histotripsy platform, Acoustiic for its ultrasound arrays, Carthera for its SonoCloud-9 device for glioblastoma, Cordance Medical for its NeuroAccess liquid biopsy device, and EDAP TMS for its Focal One platform.