PROSTATE DISEASE

Innovation is No
Longer Cutting Edge^{1, 2}

• Phased array, piezoceramic transducer with up to 1000 elements
• Advanced focusing algorithms that can be adjusted according to patient’s anatomy helping to avoid critical structures
• Personalized treatment plan utilizing focused ultrasound waves at targeted tissue (lesion)
• MRI real-time imaging guidance allows for precise delivery of energy while sparing healthy tissue
• Continuous circulation of water actively cools rectum
• Advanced software for temperature monitoring and treatment control
• For specific indications for use in each country, please refer to the Regulatory Approvals page here.

¹ The 510(k) Study
² The Phase IIB Study

Transforming Patient Care^{1, 2}

Focused ultrasound treatment is performed in the MRI suite, with the treating physician sitting at a desk using MRI & Ultrasound energy to precisely plan the treatment.

Incisionless

• Outpatient
• Fast return to daily life and activities

MRI Guided & Temperature Control

• Precise ablation
• Helps to avoid critical structures

Tissue Sparing

• Preserve healthy tissue
• Few side effects

Personalized

• Adjust treatment plan according to Prostate movements and deformations
• Individualize treatment to account for non-homogenous prostate tissue

¹ The 510(k) Study
² The Phase IIB Study

Post Treatment

After treatment, the endorectal transducer will be removed and the patient will be moved to recovery per standard of care prior to discharge. If needed, the urinary catheter will remain in the bladder for up to a week, based on the doctor’s decision. Patients may be prescribed medication to prevent potential catheter complications and, if needed, to alleviate pain.

Clinical Evidence

An Insightec-sponsored pivotal trial of 101 subjects, evaluating safety at 12 months and effectiveness at 6 months, showed:

• 91% had a negative biopsy rate at 6 months
• 92% had no erectile dysfunction at 12 months
• No serious adverse events at 6 months
• Highest recorded adverse effects at 12 months include erectile dysfunction and urinary incontinence at 8% and 3.5%, respectively.

Important Safety Information

Patients and physicians should have a detailed conversation regarding risks and complications, also known as adverse events, that patients may experience. This procedure may not be suitable for patients who aren’t eligible for MRI treatment (such as those with a pacemaker), general anesthesia or epidural.

In addition to the information in this brochure, full safety information can be found at here.

Potential Risks Associated with Exablate Prostate

The majority of adverse events (AEs) reported at 6 months in our pivotal trial 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.

Potential risks related to the procedure include pain, bruising, or infection in the area of the IV catheter; soreness/discomfort, blood clot, deep vein thrombosis (DVT) or pulmonary embolism due to lying stationary during the procedure; and risks arising from anesthesia, MRI contrast agent, and urinary catheter used during the procedure.