Profound Medical Receives IDE Approval from FDA to Conduct TULSA Clinical Trial for New Treatment for Localized Prostate Cancer
Profound Medical is pleased to announce that the FDA has granted it IDE approval to conduct a clinical study of its device for the treatment of localized prostate cancer.
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 vendors and can be moved independently from scanner to scanner. Profound Medical’s TULSA trial will effectively collect clinical data in multiple jurisdictions concurrently, accelerating the company’s commercialization plans. "We believe the TULSA clinical trial will radically change the perception of localized prostate cancer treatment, raising the bar for improved efficacy, faster recovery, and better long-term quality of life" concludes Plymale.
About Profound Medical Inc
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.
For more information, please contact:
Steven Plymale Tel: +1 647 476 1350 ext. 401 Fax: +1 647 847 3739
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