Insightec Ltd. announced that the Exablate Prostate system received CE Mark for treating locally-confined prostate cancer with MR-guided Focused Ultrasound (MRgFUS).
One in six men will be diagnosed with prostate cancer during their lifetime. Many patients are diagnosed with locally-confined disease with low or intermediate risk for progression. In these cases, patients may choose active surveillance or an intervention. Currently available treatments including prostatectomy, which surgically removes the entire prostate, and radiation therapy, targeting the full prostate, demonstrate good cancer control, however there is high risk of impotency and incontinence.
The Exablate Prostate system is based on Insightec's proprietary MRI-guided focused ultrasound technology. It uses focused ultrasound waves to precisely target and ablate (destroy), the targeted tissue in the prostate, while minimizing damage to adjacent structures. The treatment is done under magnetic resonance imaging (MRI) guidance for high resolution visualization of the patient's anatomy as well as real-time temperature monitoring. The treatment does not require incisions, is performed in a single session, allowing patients to quickly return to normal activity.
"Focused ultrasound treatment for prostate cancer may offer a novel method to re-think the management of locally-confined prostate cancer in select patients," said Behfar Ehdaie, M.D., MPH Surgeon, Memorial Sloan Kettering Cancer Center. "MR imaging allows real-time visualization and temperature feedback to surgeons to allow for precision in tissue ablation and preservation of healthy tissue," he concluded.
"Insightec has reached another important strategic milestone. We remain focused on expanding the Exablate technology platform to address multiple clinical indications and treat more patients worldwide," said Maurice R. Ferré, M.D., Insightec 's CEO and Chairman of the Board.
The Exablate Prostate system features an endorectal probe integrated into a treatment bed which is compatible with GE MRI 1.5 and 3T. Ultrasound energy is delivered by a high frequency, 1,000-element phased array transducer which delivers focal therapy under MRI guidance and real time thermal feedback. This enables the physician to control and personalize the therapy.
For more information: www.insightec.com.
December 10, 2025 
