PMI initiates Transurethral Ultrasound Ablation (TULSA) clinical trial
for novel, minimally invasive device for localized prostate cancer
TORONTO, April 25, 2013 /CNW/ - 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,
Ontario, 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,"
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 ultrasound energy 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.
SOURCE: Profound Medical Inc.
For further information:
Tel: +1 647 476 1350 ext. 401
Fax: +1 647 847 3739