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, 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 Japan,2 with incidence rates expected to increase by approximately 6 percent 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.
Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO, a 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, a 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.
1 OECD (2019), Magnetic resonance imaging (MRI) units (indicator). doi: 10.1787/1a72e7d1-en (Accessed on 30 May 2019)
2 Globocan 2018
3 Baade, 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