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Profound Medical Corp. Announces Chinese Food and Drug Administration Approval for Sonalleve®
TORONTO, May 09, 2018 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX-V:PRN) (OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide a therapeutics platform that provides the precision of real-time Magnetic Resonance (“MR”) imaging combined with the safety and ablation power of directional and focused ultrasound technology for the incision-free ablation of diseased tissue, announced today that the Chinese Food and Drug Administration (“CFDA”) has approved Sonalleve® for the non-invasive treatment of uterine fibroids.
Uterine fibroids, or leiomyoma, are the most common non-cancerous tumors of the female reproductive tract in women. Affecting an estimated 20-50% of women over 30 years of age, the disease can cause painful symptoms and abnormal menstrual bleeding. Currently, the most common medical treatment for this disease is hysterectomy. Involving invasive surgery, hospitalization and extensive recovery time, hysterectomy also results in a women’s permanent inability to have children.
Sonalleve® is an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve® can offer women with uterine fibroids a quick, non-invasive therapy option. Patients usually go home the same day and return to their routines within two days.
“Obtaining CFDA approval for Sonalleve® marks a major milestone for our Company and provides important additional validation of this powerful, patient-friendly new approach to treating uterine fibroids,” said Arun Menawat, Profound’s CEO. “Our distribution partner, Philips, enjoys a strong brand position in China, having installed MR imaging systems in many of the country’s largest hospitals. That, combined with the recent appointment of Ian Heynen to lead our global sales and marketing function, positions us very well to plan and execute the commercial launch of Sonalleve® in this very large and attractive market.”
About Profound Medical Corp.
The Profound Medical Corp. team is committed to creating the powerful combination of real-time MR-guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative tools to clinicians. These key technology pillars, linked with intelligent software and robotics, have the potential to fulfill unmet needs of patients and clinicians in many anatomies and disease states, including prostate cancer, uterine fibroids, and bone metastases. Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.
Profound 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 currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions. The Company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which, if successful, is expected to support its application to the FDA for clearance to market TULSA-PRO® in the United States.
Profound Medical is also commercializing Sonalleve®, an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve® is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The Company is also in the early stages of exploring additional potential treatment markets for Sonalleve®, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application.
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, uterine fibroids and palliative pain treatment. 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), nor the OTCQX accepts responsibility for the adequacy or accuracy of this release.
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Chief Financial Officer and Senior Vice-President of Corporate Development