Profound Medical Corp. Announces First Patient Treated in TACT Pivotal Clinical Trial at Vanderbilt University Medical Center

TORONTO, Sept. 22, 2016 -- Profound Medical Corp. (TSXV:PRN) (“Profound” or the “Company”) a medical device company focused on prostate care, today announced that the first patient has been treated in the TACT Pivotal Clinical Trial at Vanderbilt University Medical Center in Nashville, TN.

TACT (TULSA-PRO™ Ablation Clinical Trial) is a prospective, single-arm pivotal clinical study of 110 patients aimed at further evaluating the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer. TULSA-PRO combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. Multiple sites throughout the United States, Germany, Netherlands, Spain and Canada will participate in this trial.

Prostate cancer is the second most common cancer among men. With current disease management of prostate cancer, patients often experience side effects such as long-term erectile dysfunction, urinary incontinence and bowel complications that negatively impact quality of life.  

In a previous Phase 1 clinical study, TULSA-PRO demonstrated accurate and precise ablation of targeted prostate tissue, while providing a well-tolerated favorable safety profile with minor impact on urinary, erectile and bowel function at 12 months. The results of this study were published in the September 2016 issue of European Urology.

“Enrolling the first patient in this trial is truly exciting for our institution. We recognize the potential value that TULSA-PRO provides to the clinical community to address the unmet needs associated with current prostate cancer treatments,” said Dr. David Penson, Professor and Chair, Department of Urologic Surgery, principal investigator at Vanderbilt University Medical Center. “We are pleased to collaborate with the other clinical trial sites in the effort to advance this promising therapy.”

Arun Menawat, Chief Executive Officer of Profound, added, “The enrollment of the first patient in the TACT pivotal study is another important milestone for our Company. We believe this study will affirm the results of our Phase l trial, demonstrating that TULSA-PRO is an attractive clinical option for patients with localized prostate cancer.”

About Profound Medical Corp.

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.

About TACT Pivotal Clinical Trial

TACT (TULSA-PRO Ablation Clinical Trial) is a prospective, single-arm pivotal clinical study of 110 patients aimed at further evaluating the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer. The primary endpoints are safety, as defined by frequency and severity of adverse events deemed related or possibly related to the device, procedure, or ablative process, described using the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events), and efficacy, as measured by the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value. The study population is male, 45 – 80 years, and diagnosed with organ-confined low or intermediate risk prostate cancer. Multiple sites throughout the United States, Canada and Europe will participate in this trial. For additional information on trial, visit clinicaltrials.gov  

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 Profound. 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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact:

Stephen Kilmer
Tel.: + 1.647.872.4849
E-mail: [email protected]