TORONTO, March 27, 2017 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSXV:PRN) (OTCQX:PRFMF) (“Profound” or the “Company”), an emerging medical device company focused on prostate care, today announced that the first TULSA-PRO® patient paid procedure has been successfully conducted at the ALTA Klinik (“ALTA”) in Bielefeld, Germany under the supervision of Dr. Agron Lumiani.
TULSA-PRO combines real-time Magnetic Resonance Imaging (“MRI”) 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. The technology has demonstrated accurate and precise ablation of malignant prostate tissue, while providing a favourable safety profile, with low rates of serious or long-term adverse events.
The procedure was administered by Dr. Lumiani, founder of the ALTA Klinik, a leading German radiologist and an early adopter of MRI diagnostics and MRI-targeted prostate biopsy. Dr. Lumiani intends to leverage TULSA technology for focal therapy in the treatment of patients with localized prostate cancer, and also believes that TULSA-PRO holds promise for ablation in other prostate conditions.
“ALTA was established as a state-of-the-art clinic offering the most innovative diagnostic procedures and treatments,” commented Dr. Lumiani. “MRI continues to become a more trusted tool for diagnostics and biopsy of prostate cancer. Since 2009, the clinic has specialized in MRI diagnostics and MRI-targeted prostate biopsy. Profound’s TULSA-PRO system aligns well with this concept, now enabling treatment under real-time MR guidance and control. TULSA-PRO can complete this paradigm shift, potentially offering patients a therapy that is safe and effective, with minimal side effects. I am optimistic about the technology and look forward to making it available to our patients.”
“This is a great step forward in Profound’s journey to commercialize the TULSA-PRO system in Europe and build awareness about the technology as an attractive clinical option for patients with localized prostate cancer,” commented Arun Menawat, Profound’s CEO. “We also believe it will act as a strong catalyst for further adoption of the therapy as we continue our penetration into other European and international markets. We look forward to working with Dr. Lumiani to address the unmet needs of patients who suffer from this disease.”
Profound is currently conducting a pilot commercial launch of TULSA-PRO in key European and other CE mark jurisdictions. The Company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology. If successful, TACT is expected to support Profound's application to the FDA for approval to market TULSA-PRO in the United States.
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.
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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