TORONTO, 31 January 2018 (GLOBE NEWSWIRE) - Profound Medical Corp. (TSX-V:PRN) (OTCQX:PRFMF) ("Profound" or the "Company"), the only company to offer a therapeutic platform that provides the precision of real-time MR imaging combined with the safety and accuracy of directional (inside-out) and focused (outside-in) ultrasound technology for incision-free ablation of diseased tissue, today announced the completion of patient enrollment in the TACT (TULSA-PRO® Ablation Clinical Trial) pivotal study designed to further evaluate the safety and efficacy of TULSA-PRO® to ablate prostate tissue in patients with localized, organ-confined prostate cancer.

TACT, a prospective, open-label, single-arm pivotal clinical study, has enrolled 110 prostate cancer patients across 13 research sites in the U.S., Canada and Europe. If successful, TACT is expected to support Profound's application to the U.S. Food and Drug Administration ("FDA") for clearance to market this technology in the United States.

The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific antigen ("PSA") reduction ≥ 75% of their pre-treatment baseline value. The Company's pre-established performance goal for the success proportion is 50% of patients. Based on a preliminary analysis performed by the Company, of the first 63 evaluable patients, the median PSA reduction to-date is 93%, and 92% (58 out of 63) have achieved the PSA reduction success proportion.
The primary safety endpoint is the frequency and severity of adverse events, with additional secondary endpoints focused on quality-of-life side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction and urinary incontinence. As the standard evaluation period for these side effects is 12 months post-treatment, the sample size of evaluable patients is not yet large enough to assess.

"It is very exciting the TACT trial has completed accrual in such a timely manner," said Dr. Scott Eggener, TACT's Principal Investigator, Professor of Surgery and Radiology and the Director of the Prostate Cancer Program at the University of Chicago. "Today, the gap between active surveillance and radical treatments such as surgery and radiation is often too wide for both clinicians and patients. TULSA-PRO® is a minimally-invasive and image-guided option intending to ablate low and intermediate risk prostate cancers with the goal of reducing the risk of side-effects commonly associated with other treatments. There has been a smooth collaboration between the various clinical sites and Profound and we all are looking forward to seeing the final results."

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