Profound Medical Presents Successful 12-Month Phase I Outcomes at the European Symposium on Focused Ultrasound Therapy

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-PRO^TM 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.

The primary endpoints of the Phase I Clinical Trial at 12-month follow-up were met, and results support the objectives of conservative whole-gland prostate ablation. The upcoming Pivotal Clinical Trial will aim to eliminate the safety margin and completely ablate the prostate to the capsule, measuring oncological outcomes while maintaining a similar well-tolerated safety profile.

"This prospective Phase I study demonstrated clinical safety and precision of TULSA-PRO for whole-gland prostate ablation, with low toxicity and a well-tolerated safety profile. We are pleased to be moving on to our next milestone of a larger multi-jurisdictional study of 110 patients at 10 clinical trial sites in 2016," said Steve Plymale, CEO, Profound Medical Corp.

Profound Medical CEO, Steven Plymale, and members of the clinical team will host a teleconference to review and discuss these results:

An audio file of the teleconference and Dr. Popeneciu's presentation will be available on the Company's website, profoundmedical.com, under Presentations and Papers in the Investor Relations section.
 

About Profound Medical Corp.

Profound Medical is a Canadian medical device company that has developed a unique and minimally invasive treatment to ablate the prostate gland in prostate cancer patients. Profound's novel technology combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop thermal feedback control. It provides a highly precise treatment tailored to patient-specific anatomy and pathology. This method of prostate ablation offers short treatment times and low morbidity, allowing for fast patient recovery. The potential of this technology is currently being demonstrated in clinical trials. For more information, visit profoundmedical.com

Notice regarding forward-looking statements:

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound's technology in the treatment of prostate cancer. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

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