Toronto, Ontario (PRWEB) February 20, 2014
Today, Profound Medical Inc. announced the initiation of the TULSA (Trans Urethral Ultrasound Ablation) clinical trial in the United States. The first US patient was treated on January 25, 2014 and the procedure was performed at Beaumont Hospital, Royal Oak by urologist, James Relle, M.D.
“We are pleased to announce the initiation of the TULSA clinical trial at the William Beaumont Hospital,” states Steven Plymale, Chief Executive Officer of Profound Medical, “This is a controlled trial, designed to enroll low risk prostate cancer patients. We believe that this team's clinical expertise combined with our technology will demonstrate the tremendous potential of this minimally invasive approach to providing a rapid and accurate treatment for localized prostate cancer. Data from the TULSA trial will support our U.S. regulatory filings.”
The technology is designed to treat the whole gland in one session with unprecedented accuracy and minimal side effects, potentially reducing the long-term complications of traditional prostate cancer treatments. Treatment is delivered in an MRI suite, as an out-patient session and the patient returns home after a short recovery period. “The objective of the TULSA study is to demonstrate it is possible to safely and effectively eliminate the cancerous tissue with potentially much lower risk of side effects such as long-term impairment to bladder or bowel control, or erectile function,” comments Plymale.
Enrollment in the TULSA study is currently open at sites in the United States, Canada, and Germany.
About Profound Medical
PMI is a Canadian medical device company that is developing and commercializing a unique, minimally invasive treatment for prostate cancer. PMI’s novel technology combines Magnetic Resonance Imaging (MRI) guidance and high-energy ultrasound to deliver thermal ablative therapy to the prostate gland. Delivered via a trans-urethral approach, the technique combines the image quality of MRI with thermal ultrasound as the treatment tool. This method of prostate cancer treatment affords highly accurate and precise treatment within the prostate gland in a short time span in an outpatient setting. The potential of this technology is currently being demonstrated in Phase I clinical trials.
For more information, please contact:
Tel: +1 647 476 1350 ext. 401
Fax: +1 647 847 3739