Profound Medical Inc.
Treatment for Localized Prostate Cancer
Factsheet
Our Solution: TULSA
One and Done:
Single session procedure; actual treatment time of less than 40 minutes
Ablate Prostate from Inside-Out:
Inherently safer than outside-in
Robotic Applicator:
Robotically controlled rotation position and speed
Precise Ablation With Millimeter Accuracy:
Robotic applicator, real-time MRI Guidance, real-time temperature guidance and control
Actively Protect:
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
“This is an exciting time in the treatment of localized prostate cancer. TULSA-PRO™ is a unique therapy that is showing to be effective and accurate. It appears to be well-tolerated by patients and has to date shown to have low side effects, with minor or no impact to erectile and urinary function. This helps patients quickly get back to their normal quality of life, which is a critical outcome when evaluating their treatment options. Although the precise role of TULSA-PRO™ in the management of localized prostate cancer still needs to be confirmed by larger and more extensive studies, the results from our first trial are very encouraging.”
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
The Profound Medical team is committed to the effort to achieve a new therapeutic standard in prostate cancer. For the millions of men currently living with prostate cancer, and the thousands more who are diagnosed with it every year, current treatment options often mean having to make difficult choices based on potential side effects that can significantly impact quality of life. Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate cancerous prostate tissue with precision, while actively protecting critical anatomy from potential side effects; a tomorrow where patients have access to a safe, fast and effective treatment option, so they can quickly return to their daily lives.
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