Sonire Therapeutics has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Suizenji high-intensity focused ultrasound (HIFU) system, intended for the treatment of pancreatic cancer. The FDA's decision is based on the potential of the device to offer a more effective treatment option for this aggressive disease, which is estimated to cause over 51,000 deaths in the United States in 2024.
The Suizenji HIFU system utilizes cavitation ultrasound to deliver targeted thermal therapy. According to Sonire Therapeutics, the system's design allows for the use of lower acoustic energy while maintaining image clarity, potentially improving both safety and treatment efficacy. Tohru Satoh, CEO of Sonire Therapeutics, highlighted these features as crucial for achieving optimal safety and treatment throughput.
Ongoing Clinical Evaluation
The Suizenji HIFU system is currently being evaluated in a Phase 2 clinical trial. This trial is comparing the efficacy of the HIFU system in conjunction with second-line chemotherapy against second-line chemotherapy alone in patients with unresectable pancreatic cancer who have become refractory or intolerant to initial chemotherapy regimens. The trial aims to determine if the addition of HIFU therapy can improve outcomes in this challenging patient population.
Mechanism of Action
The Suizenji system's approach involves delivering focused ultrasound energy to the tumor site, inducing thermal ablation and cavitation. This targeted approach aims to destroy cancer cells while minimizing damage to surrounding healthy tissue. The integrated imaging capabilities of the system allow for precise targeting and monitoring of the treatment.
Implications of Breakthrough Designation
The FDA's Breakthrough Device program is designed to accelerate the development and review of medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This designation provides Sonire Therapeutics with increased access to the FDA's expertise and resources, potentially speeding up the regulatory pathway for the Suizenji HIFU system.
