Sonablate Corp.

Sonablate Corp. manufactures the Sonablate® HIFU (High-Intensity Focused Ultrasound) system, an FDA-cleared minimally invasive device for focal ablation of prostate tissue. The system provides customizable focal therapy with robotic accuracy and real-time ultrasound feedback, positioned as a precision alternative between active surveillance and surgery or radiation. The device incorporates multiple safety features including Tissue Change Monitoring, Total Acoustic Power tracking, and Reflexivity Index Monitoring to enable physician-controlled, safe ablation procedures. Sonablate HIFU received FDA clearance as the first focused ultrasound device approved for prostate tissue ablation in the United States and is available in more than 50 countries worldwide. The company supports clinical evidence demonstrating medium-term disease control in treated patients and provides educational resources and webinar series to assist healthcare institutions in developing focal therapy programs. The system is restricted to sale by or on the order of a physician per federal law.