Profound Medical’s TULSA-PRO™, a real-time, MRI-guided, minimally invasive focused ultrasound device, was granted CE approval on April 11 for the commercial sale in Europe and in 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.
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.”
Pivotal Clinical Trial
Ultimately, the company will seek regulatory approval in the US. They will soon begin a pivotal clinical trial of safety and efficacy at more than 10 sites in the US, Canada, and Europe. The prospective, multi-center, single-arm study of 110 patients with low and/or intermediate risk prostate cancer is designed to generate robust data that will give confidence to the clinical community. Without a comparator arm, they expect to be able to enroll a younger population of patients based on their broad inclusion criteria. They plan to follow participants for five years and will create a patient registry to aggregate and analyze the data.
“We want to ultimately be a cancer treatment, so we are very focused on the long-term goal of demonstrating cancer-free survival,” says Plymale. “This 110-patient study will initially give us the platform to be approved as an ablation tool. Following this, we will continue to track the patients and collect the data necessary to be a cancer treatment.”
The company is also optimistic about reimbursement. “We can heat a very large prostate in under an hour using real-time imaging. We think that payment for this should be equivalent to what is done in the operating room, so we will advocate for reimbursement compatible with other whole gland therapies.”
Collaborating with MR Imaging Leaders
Profound’s technology was designed to be compatible with leading MRI systems. They have forged collaborations with both Philips and Siemens Healthcare to integrate TULSA-PRO with their imaging platforms.
“These companies are active in diagnosis, navigation, and biopsies–and now they will have access to a groundbreaking therapy,” says Plymale. “We have a unique opportunity to collaborate with strategic partners that have a similar interest in furthering image-guided therapy to round out their offerings. There are about 13,000 MRIs in the US, and we believe that each should have a TULSA-PRO attached to it.”
Profound Medical is a rapidly rising star in the field. The company was founded in 2008 at Sunnybrook Research Institute in Toronto by professors Michael Bronskill, PhD, and Rajiv Chopra, PhD. Plymale joined in 2009 as an independent director, advising the company based on his two decades in medical device senior management; he became CEO four years ago.
The company initially embarked on a costly and complex PMA regulatory pathway for entering the US market. The FDA’s outlook on the risk profile of ultrasound-based therapy changed with Sonacare’s de novo application followed by EDAP-TMS’ 510K approval for prostate ablation late last year. Profound has since been able to refine their clinical and regulatory strategy to take advantage of the new climate.
Although Plymale explains that it has been difficult to work with the materials required for developing MR-compatible focused ultrasound technology, he says that the engineering challenges pale when compared to the business headwinds. “The biggest challenge has not been engineering-related, but involves financing and growth,” he explains. “In 2010, we had six people, and now we are a team of 45 and we need to be ready to scale up the operation and take it to the next level. That is where we need to be really nimble and adept.”
While he sees potential for treating other diseases in the future, the company for now remains committed to providing a superior solution to men with prostate cancer. “We are developing a new option that will potentially provide men with equal or better outcomes than the standard of care in terms of side effects and quality of life. This is the sweet spot of medical innovation,” Plymale states.
Posted April 2016