TORONTO, Oct. 15, 2015 (GLOBE NEWSWIRE) -- Profound Medical Corp. ("Profound" or "Company") (TSXV:PRN), a medical device company developing and commercializing a unique, minimally invasive treatment to ablate the prostate gland in prostate cancer patients, is pleased to announce that Dr. Ionel Valentin Popeneciu of the University Hospital Heidelberg in Germany, today presented 12-month data of the TULSA-PROTM Phase I Clinical Trial in an abstract entitled, Heidelberg First Clinical Experience with Profound Medical Inc.'s MRI guided TULSA-PRO.

TULSA is a novel, minimally invasive technology to ablate normal and cancerous prostate tissue, which combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop temperature feedback control.

Thirty (30) patients with low/intermediate risk, organ confined prostate cancer were enrolled in this multi-jurisdictional trial. Inclusion criteria included ages 65 years or older, clinical stage T1-T2a; PSA ≤ 10 ng/ml; Gleason Score ≤ 3+3 (USA/Europe) and ≤ 3+4 (Canada). Treatment planning was performed under MRI visualization with therapeutic intent of conservative whole-gland ablation, including 3 mm safety margins around the periphery and at the apex. These safety margins were included due to the nature of this first-in-human Phase I safety and feasibility study, leading to approximately 10% residual viable tissue expected around the gland periphery. Ultrasound treatment was delivered under real-time active MRI thermometry feedback control.
Highlights of study results:

MRI-guided TULSA provides accurate treatment planning, real-time thermal dosimetry and precise control of prostate ablation to +/- 1.3 mm, with a well-tolerated side-effect profile.
There were no intraoperative complications, no rectal injury or fistula, no Grade 4 or higher adverse events, only one attributable Grade 3 adverse event (GU infection, resolved within 2 weeks), and an erectile dysfunction rate of 8% (IIEF item 2 ≥ 2).
At 12 months, 1/30 (3.3%) patients had Grade 1 urinary urge incontinence, meaning that it was occasional (with coughing, sneezing) and does not require pads. Functional quality-of-life outcomes showed a favourable, anticipated trend of initial deterioration with subsequent improvement in performance back to baseline levels, within 3 months (IPSS, UCLA-PCI-SF Bowel Habits) and 12 months (IIEF).
Exploratory endpoints of treatment efficacy (including PSA and biopsy) showed median PSA decreasing 87% to 0.80 ng/ml, and overall absence of clinically significant disease in 69% of patients, in spite of the deliberately conservative safety margin.

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