Profound Medical Corp. announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.
TULSA-PRO is a unique technology that combines real-time Magnetic Resonance Imaging (MRI) with transurethral robotically-driven ultrasound and closed-loop thermal feedback control providing a highly precise prostate treatment tailored to patient-specific anatomy.
“We are delighted to announce that TULSA-PRO has received IDE approval,” commented Profound CEO, Steve Plymale. “With this approval, clinicians participating in the study will be able to further validate the efficacy of this innovative technology. The commencement of this multijurisdictional Pivotal Trial is a significant milestone for Profound as it aims to establish TULSA-PRO as a minimally invasive alternative to other prostate care therapies.
This study is expected to set the path to 510k regulatory approval and we look forward to working with the FDA to bring this unique technology to clinicians and patients across the United States.”
Dr. David Penson, Professor and Chair, Department of Urologic Surgery, and Dr. Sandeep Arora, Assistant Professor of Radiology at Vanderbilt University Medical Center, one of the sites chosen to conduct the Pivotal Trial, said. "We are very pleased to learn about the IDE approval for the TULSA-PRO device. As an institution, we recognize the potential of MR-guided therapeutic ultrasound ablation and are investing a lot of resources in this direction. We expect prostate ultrasound ablation to be an important part of our therapeutic armamentarium in the future. Vanderbilt's team of urologists, radiologists, anesthesiologists, researchers and support personnel is working hard to get this exciting clinical trial off the ground."
Profound expects to initiate patient enrollment in its Pivotal Trial in the coming months. Overall, the study is expected to enroll 110 patients at as many as 15 sites throughout the United States, Europe and Canada.
