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PMI initiates Transurethral Ultrasound Ablation (TULSA) clinical trial for novel, minimally invasive device for localized prostate cancer treatment TORONTO,
April 25, 2013 /PRNewswire/ - Profound Medical Inc. today announced the commencement of its Health Canada approved, multi-center TULSA (Transurethral Ultrasound Ablation) clinical trial for its minimally invasive, novel ablation device used to facilitate prostate cancer treatment. In the world's first procedure of its kind, a patient was treated in a collaborative effort with London Health Sciences Center,
Western University, and the Lawson's Health Research Institute. The Canadian trial will include the treatment and one-year monitoring of 30 patients with localized prostate cancer. The device presents the potential for significantly improved clinical outcomes and a marked departure from current methods by virtue of its ability to treat the whole gland in one session with unprecedented accuracy and minimal side effects.
"I believe this represents a significant advance in the management of prostate cancer. We hope the TULSA clinical trial will show that this system can provide an efficacious and minimally invasive treatment for localized prostate cancer, with a favorable treatment-related morbidity profile," states Joseph L. Chin, M.D., Professor of Urology & Oncology,
University of Western Ontario and Principal Investigator of the study. Combining the use of thermal ultrasound therapy with real-time MR Image guidance, the Profound system operates safely within an MRI suite and offers clinicians an acutely targeted treatment using a minimally invasive, trans-urethral approach.
The Profound treatment is completed in a single session and enables the patient to return home after a short outpatient recovery period. "It's not a question of improving mortality rates - those are already very good. This is about improving quality of life outcomes," states
Steven Plymale, CEO at Profound Medical, "The objective of our trial is to demonstrate that it's possible to safely and effectively eliminate the cancerous tissue with decreased risk of side effects such as long-term impairment to bladder or bowel control, or erectile function."
The technology leverages years of research and development, initially performed in collaboration with the Sunnybrook Research Institute. Profound Medical has advanced the technology from an early prototype stage to the clinical ready stage of the device and has ensured that it will work across multiple MRI platforms from various vendors and can be moved independently from scanner to scanner. Profound Medical plans to pursue clinical data collection in multiple jurisdictions concurrently in an effort to accelerate its commercialization plans. "The TULSA clinical trial marks a major milestone in our company's evolution and the way that localized prostate cancer will be treated going forward," concludes Plymale.