Toronto, Ontario (PRWEB) September 17, 2013
Profound Medical Inc. today announced that the US Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to the company to conduct a clinical study of its device for the treatment of localized prostate cancer. The company is now proceeding with U.S. institutional review board submissions and anticipates initiating patient enrollment later this year.
"This is another exciting milestone for Profound Medical and we look forward to initiating our U.S. clinical trial in the coming months. The TULSA trial is a key step in validating a new, alternative therapy for treating localized prostate cancer that minimizes the risks commonly associated with treatment," states Steven Plymale, CEO at Profound Medical.
The Profound device presents the potential for significantly improved clinical outcomes and represents 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. "The objective of the TULSA trial is to demonstrate that effective elimination of cancerous tissue can be achieved safely, precisely and with significantly less risk to bladder, bowel, and erectile functions," comments Plymale.
Combining the use of thermal ultrasound therapy with real-time MR Image guidance, the Profound system operates safely within an MRI suite, offering unparalleled accuracy, using a minimally invasive, trans-urethral approach. Performed as a single session outpatient procedure, the Profound treatment affords the patient the ability to return home after a short recovery period.
Leveraging years of research and development, initiated in collaboration with the Sunnybrook Research Institute, Profound Medical’s technology is currently at clinical-ready stage. The device can function across multiple MRI platforms from various ve
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