TORONTO, April 11, 2016 (GLOBE NEWSWIRE) -- Profound Medical Corp. (“Profound” or “Company”) (TSXV:PRN), a medical device company commercializing a unique and minimally invasive therapy in prostate care, today announced that the company has received CE Mark approval for the commercial sale of TULSA-PROTM.
“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with TULSA-PRO,” said Steve Plymale, CEO.
Profound’s novel technology combines real-time Magnetic Resonance (MR) imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control, providing a highly precise treatment tailored to patient-specific anatomy and pathology.TULSA-PRO has demonstrated accurate and precise ablation of prostate tissue, both malignant and benign, while providing a favourable safety profile and a low rate of erectile dysfunction.
Prof. Dr. med. Dipl.-Phys. Heinz-Peter Schlemmer and Prof. Dr. med. Boris Hadaschik of University Hospital of Heidelberg, Germany, lead researchers of the completed Phase l Clinical Trial, acknowledged Profound’s regulatory accomplishment. Prof. Schlemmer remarked: “MRI-guided TULSA-PRO is excellent for planning, guiding and monitoring focal prostate cancer treatment in order to maximize the therapeutic effect and avoid adverse effects.” Prof. Hadaschik added that, “Obtaining a CE Mark for TULSA-PRO is an important step forward to broaden the therapeutic offering for localized prostate cancer.”
Profound Medical GmbH, a subsidiary of Profound Medical Corp., has been established in Hamburg, Germany to support European commercial operations. The commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will commence immediately.
About Profound Medical Corp.
Profound Medical is a Canadian medical device company that has commercialized a unique and minimally invasive procedure to ablate the prostate gland. Profound’s novel technology combines real-time MR 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 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 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.
Investor and media contacts:
Steve Plymale
CEO
Profound Medical Corp.
splymale@profoundmedical.com
T: 647-476-1350, Ext. 401
Rebecca von Goetz
Senior Marketing & Communications Specialist
Profound Medical Corp.
rvongoetz@profoundmedical.com
T: 647-476-1350, Ext. 426
C: 416.917.8650
