Traditional surgical and radiological approaches - along with a growing number of emerging technologies – to prostate cancer have made it a controllable disease for many men. At the same time, the drawbacks of these procedures come with potentially serious consequences for men’s quality of life, and sometimes result in greater burdens on health systems than necessary.
Profound Medical's TULSA-PRO® technology is at the forefront of a new era in incision-free surgery for prostate disease and, ultimately, across a broad range of indications.
To learn more about this innovative technology, Becker's Healthcare recently spoke with Arun Menawat, PhD, chairman and CEO of Profound Medical.
Incision-free treatment — better outcomes and a better patient experience
TULSA-PRO (Transurethral ULtraSound Ablation of the PROstate) is a precise, incision-free procedure that uses directional ultrasound to gently heat and destroy targeted prostate tissue from the “inside out.” Combining real-time MRI with AI-powered treatment planning, advanced robotic control and directional thermal ultrasound, TULSA precisely destroys both malignant and benign tissue in targeted areas across the entire gland or only in specific areas to make the procedure truly customizable.
"We use a gentle energy source to provide high visualization and real-time precision to heat and kill abnormal tissue," Dr. Menawat said. "Patients who undergo the TULSA-PRO procedure wake up in an hour or so. They have no incisions, which means their recovery time is hours instead of days. Most people talk and walk within an hour and go home without a hospital stay."
One of the advantages of TULSA-PRO is the ability to visualize the prostate in real time, this allows for precise targeting of cancerous tissue. The system creates boundaries around the areas of the prostate that need treatment. An autonomous robotic system then heats the tissue inside the boundaries and kills the cancer.
"The human body reabsorbs that tissue over time and patients are generally cancer free," Dr. Menawat said. "They have fewer side effects than with traditional surgeries and don't have to return for additional procedures."
TULSA-PRO procedures are performed in magnetic resonance imaging (MRI) suites on an outpatient basis. Since TULSA-PRO is an incision-free technology, blood loss is minimal, and the risk of infection is lower than with open surgeries. This enhances patient safety and has the potential to reduce hospital readmission rates. Because patients typically go home the same day as the procedure, the risk of hospital-acquired infections is dramatically decreased.
Traditional surgery for prostate cancer removes the whole gland. With TULSA-PRO, physicians can customize treatment based on each patient's unique characteristics. Prostates vary in size and prostate cancer may be concentrated in a specific area of the gland.
"If the cancer is in the nerve bundles, the physician can kill the nerve bundles," Dr. Menawat said. "If it's isolated on one side, that area alone can be treated. TULSA-PRO gives physicians the maximum ability to kill the bad tissue, while saving the healthy tissue and nerves that support urination or erectile function. That customizability is important."
Overcoming institutional barriers to adoption
As a new technology, TULSA-PRO has undergone rigorous testing, with extensive clinical trials demonstrating five-year outcomes. So far this year alone more than 25 presentations have been delivered at major medical meetings around the world demonstrating its safety, efficacy, and durability, and pointing to its potential as a mainstream treatment for prostate disease. Since TULSA-PRO’s clearance by the U.S. Food and Drug Administration in 2019, Profound has taken all the steps necessary to ensure the treatment is broadly accessible to patients and health care organizations. Beginning in January 2025 TULSA-PRO will be reimbursed. by Medicare, following the American Medical Association’s approval of new reimbursement codes for the procedure.
"Just a few weeks ago, CMS proposed what payment will be for Medicare patients," Dr. Menawat said. "Starting next year, TULSA-PRO will be covered for Medicare beneficiaries and we expect that commercial payers will slowly start covering the procedure as well."
In addition to reimbursement, physician workflow is another focus area for Profound Medical. When urologists perform robotic procedures, they typically call the hospital and book the robotic operating room. TULSA-PRO completely changes this established workflow.
"Urologists no longer have to go to an operating room," Dr. Menawat said. "Instead, they can use an MRI suite. Over the last three to four years, we've worked with urologists to identify bottlenecks, speed up processes so they become routine and change how they schedule time. It's an entirely new way of thinking."
As MRI plays a growing role in screening, detection, and treatment of prostate disease, surgeons are eager to learn how to perform the TULSA procedure, said Dr. Menawat.
Prostate care is just the beginning
Dr. Menawat believes the technology used for TULSA-PRO can be extended to new areas, such as uterus care and treatment of solid organ tumors.
"Looking to the future, the big lift is getting the medical community to think of magnetic resonance as not just a diagnostic modality, but also an interventional modality," Dr. Menawat said. "We can start to customize different energy sources that will allow us to expand from urology to general surgery, so we can treat more patients with serious diseases."
In the years ahead, the future of surgery and the care experience could look very different for cancer patients. "The vision I have is to bring the technology to a point where a patient can be diagnosed with cancer in the morning, get treated in the afternoon and go home in the evening to tell their family that they are cancer free," Dr. Menawat said.