TORONTO, July 09, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide customizable, incision-free therapies which combine real-time Magnetic Resonance Imaging (“MRI”), thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue, today announced that it has sold its first TULSA-PRO® system in Japan. The system was purchased by Hokuyu Hospital in Sapporo via Japan's Pharmaceutical and Medical Device (“PMD”) Act’s expanded access program.
The PMD Act, regulated by Japan’s Pharmaceutical and Medical Device Agency (“PMDA”) and Ministry of Health, Labour and Welfare (“MHLW”), allows physicians to import, with permission from the MHLW, an unapproved medical device directly from the distributor in cases where there is a clinical urgency and there are no alternatives in Japan.
“We are very encouraged by the sale of our first TULSA-PRO® system in Japan, enabled by Japan’s expanded access program for medical devices,” said Arun Menawat, Profound’s CEO. “This order from the Sapporo Hokuyu Hospital is a testament to the TULSA-PRO® technology and reflects the Japanese market’s increasing interest in safe, effective, incision-free procedures that are efficient to perform and result in shorter patient recovery times.”
“We are pleased to work with Profound to bring Japan’s first TULSA-PRO® system to Sapporo Hokuyu Hospital,” said Dr. Masayoshi Miura, the Director of the Department of Urology and Renal Transplantation Surgery at Sapporo Hokuyu Hospital. “The decision to procure this system was based on the compelling TACT U.S. pivotal trial data, particularly the high proportion of patients demonstrating significant reduction of prostate-specific antigen levels post-treatment with TULSA-PRO®, as well as the procedure’s favorable safety and functional side effect profile. We are currently preparing the site for the unit, and are looking forward to offering prostate cancer patients safe and effective prostate tissue ablation beginning in September 2019.”
According to the Organization for Economic Co-operation and Development (“OECD”), Japan has the highest number of MRI units per person of all OECD countries. The latest figures show that Japan has 51.7 MRI units per 1 million inhabitants, followed by the U.S. with 37.6 units per 1 million inhabitants.1
Every year, more than 70,000 men are diagnosed with prostate cancer in Japan2, with incidence rates expected to increase by approximately 6% annualy.3
“Japan is an important market for TULSA-PRO® and one in which we are seeking regulatory approval for longer-term value generation,” Dr. Menawat added. “We plan to use this opportunity to collect additional clinical data for TULSA-PRO®, which we intend to combine with the data from our TACT trial to pursue regulatory approval in Japan.”
The U.S. Food and Drug Administration (“FDA”) recently accepted Profound’s 510(k) application for premarket clearance for TULSA-PRO®, which is currently under substantive review. The Company’s TACT clinical trial, designed to support the 510(k) application, demonstrated that treatment with TULSA-PRO® provides safe and effective prostate tissue ablation in men with intermediate-risk and low-risk cancer, with little impact on men’s natural functional ability compared to standard of care radical prostatectomy. The TACT study also demonstrated a favorable risk-benefit profile when compared to other ablative approaches, including radiation therapy, whole-gland HIFU and cryotherapy.
About Profound Medical Corp.
Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a novel technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities.
TULSA-PRO® is CE marked and commercially launched in key European and other CE mark jurisdictions. TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH).
Profound recently announced positive topline results from a multicenter, prospective clinical trial, TACT, which is expected to support its recent application to the FDA for 510(k) clearance to market TULSA-PRO® in the United States.
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
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, 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.
For further information, please contact:
Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
1OECD (2019), Magnetic resonance imaging (MRI) units (indicator). doi: 10.1787/1a72e7d1-en (Accessed on 30 May 2019)
2Globocan 2018
3Baade, P. D., Youlden, D. R., Cramb, S. M., Dunn, J., & Gardiner, R. A. (2013). Epidemiology of prostate cancer in the Asia-Pacific region. Prostate International, 1(2), 47-58. doi:10.12954/pi.12014