Profound Medical Inc.
Treatment for Localized Prostate Cancer
Factsheet
Our Solution: TULSA

Single session procedure; actual treatment time of less than 40 minutes

Inherently safer than outside-in

Robotically controlled rotation position and speed

Robotic applicator, real-time MRI Guidance, real-time temperature guidance and control

Via cooling rectum and urethra to avoid long term side effects
Automated, Precise Ablation from the Inside-Out

MRI Guided Device Positioning

Precise Treatment Planning by Urologist

Automated Temperature Feedback Controlled, Robotically driven
• Controlled Algorithm Target, Temp 570 Celsius
• Ablation in 40 minutes

Confirmation of Ablation Margin with MRI
Phase I Clinical Trial: Completed
OBJECTIVE | Determine safety and feasibility of MRI-TULSA for whole-gland prostate ablation in a primary treatment setting of localized prostate cancer |
SUBJECTS | 30 Patients (Inclusion criteria: Men ≥ 65 yr, organ confined PCa, PSA ≤ 10 ng/ml, Gleason score 3+3 or 3+4) |
OUTCOMES | • 30 patients treated with at least 12 month follow-up • No intraoperative complications, no rectal injury or fistula • Erectile dysfunction rate of 8% (IIEF item 2 ≥ 2) • At 12 months, only 1 patient (3%) with Grade 1 urinary incontinence (no pads) • Functional quality-of-life outcomes back to baseline levels • Accuracy of thermal ablation +/- 1.3 mm |
TACT Pivotal Trial
OBJECTIVE | Further evaluate safety and efficacy of TULSA-PROTM intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer |
SUBJECTS | 110 Patients (Inclusion criteria: Males, age 45-80 yrs, organ confined PCa, PSA ≤ 15 ng/ml, Gleason score ≤ 3+4) |
SITES | 16 Sites, first patient September 2016 |
OUTCOMES | Primary Endpoints • Safety • Efficacy Secondary Endpoints • Frequency and Severity of Adverse Events • Rate of Erectile Dysfunction • Rate of Urinary Incontinence • PSA Levels and Stability • Prostate Volume Reduction • Prostate Biopsy (TRUS-guided 10-core) • IPSS, IIEF, EPIC changes • Targeting Accuracy • CE-MRI and mpMRI • Procedure Efficiency |
Changing the Therapeutic Prostate Paradigm
Dr. Joseph L. Chin
Chief of Surgical Oncology – Western University, London Health Sciences Centre
“Everything has returned to normal and in some cases is better that what it has been for five years.”
Brian Denter, patient

Dr. Chin and world’s first TULSA-PRO™ patient
Established in 2008, Profound Medical is commercializing a novel technology, TULSA-PRO™, which combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO™ is CE Marked and Profound is sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology.
For more details please visit our website: http://www.profoundmedical.com/about-us/
Media
Dr. Laurence Klotz