The FDA grants an investigational device exemption to Profound Medical for a clinical trial of its prostate cancer device.
Profound Medical said it won an investigation device exemption from the FDA for a clinical trial of its device to treat prostate cancer.
The Toronto-based medical device company said it hopes to begin enrolling patients later this year in the Tulsa trial.
The Profound device combines thermal ultrasound with real-time MRI guidance in a single outpatient session to treat localized prostate cancer, according to a press release.
"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," CEO Steven Plymale said in prepared remarks. "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."
Profound Medical launched a 30-patient Phase I trial of the device in Canada earlier this year.
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