Prostate tumor treatment HIFU ablation system EXABLATE

MRI-guided

Exablate® Prostate delivers up to 1000 ultrasound waves to precisely heat and ablate Prostate tissue with no surgical incisions or radiation. Treatment is guided by MR imaging for patient-specific planning, real-time temperature monitoring as well as immediate confirmation of treatment outcome. First, the clinical team will use best in class MRI to visualize the prostate throughout the treatment. The Exablate system utilizes specialized software to create a personalized plan to deliver energy effectively to target from a transrectal approach. The clinical team monitors the treatment in real-time using thermometry data to optimize the outcome and then uses a contrast image at the end of the treatment to confirm the delivery. Important Safety Information You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience. Potential Risks associated with Exablate Prostate The majority of AEs reported were either mild (86.5%) or moderate (13%). There was one AE categorized as Severe for a UTI event, which resolved in less than a week. At 12 months, the most common recorded adverse events included erectile dysfunction (16%) and urinary incontinence (7%). The remaining unresolved AEs at 24 months were less than 1% and included ejaculation disorder, urinary frequency, hematospermia, urinary hesitancy, urinary urgency, prostate cyst, and urethra stricture. The number in parenthesis is the percentage of subjects experiencing the event based on a 101 subject study.