TORONTO, May 19, 2016 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX-V:PRN), an emerging medical device company focused on prostate care, today announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.
TULSA-PRO is a unique technology that combines real-time Magnetic Resonance Imaging (MRI) with transurethral robotically-driven ultrasound and closed-loop thermal feedback control providing a highly precise prostate treatment tailored to patient-specific anatomy.
“We are delighted to announce that TULSA-PRO has received IDE approval,” commented Profound CEO, Steve Plymale. “With this approval, clinicians participating in the study will be able to further validate the efficacy of this innovative technology. The commencement of this multijurisdictional Pivotal Trial is a significant milestone for Profound as it aims to establish TULSA-PRO as a minimally invasive alternative to other prostate care therapies. This study is expected to set the path to 510k regulatory approval and we look forward to working with the FDA to bring this unique technology to clinicians and patients across the United States.”
Dr. David Penson, Professor and Chair, Department of Urologic Surgery, and Dr. Sandeep Arora, Assistant Professor of Radiology at Vanderbilt University Medical Center, one of the sites chosen to conduct the Pivotal Trial, said. "We are very pleased to learn about the IDE approval for the TULSA-PRO device. As an institution, we recognize the potential of MR-guided therapeutic ultrasound ablation and are investing a lot of resources in this direction. We expect prostate ultrasound ablation to be an important part of our therapeutic armamentarium in the future. Vanderbilt's team of urologists, radiologists, anesthesiologists, researchers and support personnel is working hard to get this exciting clinical trial off the ground."
Profound expects to initiate patient enrollment in its Pivotal Trial in the coming months. Overall, the study is expected to enroll 110 patients at as many as 15 sites throughout the United States, Europe and Canada.
Earlier this year, the Company was granted CE Mark approval for the TULSA-PRO System. The technology is now commercially available in Europe and other CE Mark jurisdictions.
About Profound Medical Corp.
Profound is a Canadian medical device company that developed a unique and minimally invasive procedure to ablate malignant prostate tissue. The Company’s novel technology combines real-time Magnetic Resonance imaging with transurethral, robotically-driven 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. For more information, visit www.profoundmedical.com
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.
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