- TULSA-PROTM Accurately and Effectively Ablates Targeted Prostate Tissue -
TORONTO, Jan. 08, 2016 (GLOBE NEWSWIRE) -- Profound Medical Corp. (“Profound” or “Company”) (TSX-V:PRN), a medical device company developing and commercializing a unique, minimally invasive technology for the clinical management of patients with localized prostate cancer, today announced that the results of their Phase I Clinical Trial have been accepted for publication in European Urology, online at http://bit.ly/1O7LVcv, the official journal of the European Association of Urology.
In the paper, entitled “Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase I Clinical Trial”, Prof. Joseph L. Chin, M.D. and his team from Western University, London Health Sciences Centre, and investigators Dr. Sasha Pahernik (University Hospital Heidelberg), Dr. James Relle (William Beaumont Hospital), and Professor Heinz-Peter Schlemmer (DKFZ) report on the single arm prospective Phase 1 study.
MRI-guided transurethral ultrasound ablation (TULSA) was used to heat and ablate prostate tissue in 30 men with localized prostate cancer. The procedure was delivered using Profound Medical’s TULSA-PROTM, with the objective to determine its clinical safety and feasibility for whole-gland prostate ablation in the primary treatment setting of patients with localized prostate cancer. The 12-month data shows that the TULSA-PRO is spatially accurate and precise to ablate prostate tissue, both malignant and benign, while providing a favourable safely profile and a low rate of erectile dysfunction.
“This is an exciting time in the treatment of localized prostate cancer,” states Dr. Chin. “TULSA-PRO is a unique therapy that is showing to be effective and accurate. It appears to be well-tolerated by patients and has to date shown to have low side effects, with minor or no impact to erectile and urinary function. This helps patients quickly get back to their normal quality of life, which is a critical outcome when evaluating their treatment options. Although the precise role of TULSA-PRO in the management of localized prostate cancer still needs to be confirmed by larger and more extensive studies, the results from our first trial are very encouraging."
Steve Plymale, CEO, remarked, "We are very pleased to see TULSA Phase I data published in such a reputable journal which acknowledges the support we have in the clinical community for this high quality work. As we prepare for our Pivotal Trial of 100 patients, we will continue to monitor our initial 30 patients for 5 years. We are excited about the possibility of providing men with an option that ensures fast recovery and reduces the adverse side effects generally associated with prostate procedures.”
About Profound Medical Corp.
Profound Medical is a Canadian medical device company that has developed a unique and minimally invasive procedure 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.
Before obtaining regulatory approvals for the commercial sale of the TULSA-PRO system in a particular jurisdiction, Profound must demonstrate through preclinical testing and clinical trials that the device is safe and effective for use. Even if Profound’s clinical trials are completed as planned, there can be no certainty that trial results will support Profound’s product candidate claims or that the regulatory authorities will agree with Profound’s conclusions regarding them or agree that they are adequate to support approval. 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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