Profound Earns European Approval for Prostate Device
Profound Medical’s TULSA-PRO™, a real-time, MRI-guided, minimally invasive focused ultrasound device, was granted CE approval on April 11 for commercial sale in Europe and other CE Mark jurisdictions. The approval was based on a 30-patient phase I study conducted in the US, Canada, and Europe that demonstrated that TULSA-PRO precisely ablates prostate tissue, with low toxicity and a well-tolerated safety profile. The company will start with launching commercial and clinical activity in Germany, and expand into countries that have modest levels of reimbursement, such as France, Spain, and the UK; and then seek distribution partners for other CE compatible countries.
“This is the first of several regulatory approvals we expect in the next few years,” says CEO Steve Plymale. “I give a lot of credit to our team, who in just eight years since our company was founded, engineered the technology to address the unmet needs of localized prostate cancer treatment. We are excited to provide clinicians and their patients with an option that has the potential for fast recovery and reduced adverse side effects generally associated with the current standard of care for prostate therapy.”
The company plans to hit the ground running with a Center of Excellence program to connect with early adopters. The centers will enable new and prospective customers to get an in-depth understanding of TULSA and offer an accredited CME training program and workshops.
PLYMALE DISCUSSES THE COMPANY'S STRATEGY >
A New Approach to Destroying Prostate Tissue
Profound’s technology combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop thermal feedback control. It provides a highly precise treatment tailored to patient-specific anatomy and pathology. A transurethral ultrasound applicator is inserted and ablates the prostate from inside-out, which, according to the company, could be safer and more effective than a transrectal approach. “What makes us unique is that we have an inside-out approach – we start inside the prostate and heat toward the capsule,” says Plymale. “We don’t need to go near the rectal wall or other structures that are very sensitive and could be damaged by the ablation.”
Guided by real-time MR imaging with temperature feedback, the treatment is conducted with millimeter accuracy, less risk, and a lower morbidity profile than traditional approaches like surgery or radiation. Plymale says that their system is flexible to meet the needs of patients and physicians – “TULSA-PRO will be useful for either focal therapy or whole gland ablation.”
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