Perioperative data from the CAPTAIN randomized trial indicated lower blood loss, shorter length of stay, reduced post‑operative pain, and faster recovery with MRI‑guided transurethral ultrasound ablation compared with robotic radical prostatectomy. Real‑world experience cited by the company has also associated the approach with a reduced risk of sexual dysfunction and incontinence, though detailed figures were not disclosed.
The core development is Profound Medical’s launch of its TULSA‑AI Volume Reduction module aimed at optimizing benign prostatic hyperplasia procedures on the existing TULSA‑PRO platform. Debuting at RSNA, the software is positioned to streamline workflow and compress procedure times so sites can schedule multiple BPH or mixed‑indication cases in a single day using the same hardware, teams, and reimbursement pathways. Alongside the software launch, the company plans to present additional TULSA‑PRO data at RSNA and at the Society for Urologic Oncology meeting, including randomized and single‑center outcomes in prostate cancer. Profound projects the BPH module could expand its annual addressable patient pool to roughly 600,000 by opening access beyond cancer‑focused ablation to the larger symptomatic BPH market. The TULSA‑PRO system holds FDA 510(k) clearance, CE mark, and Health Canada approval.
Strategically, this is an expansion move designed to drive utilization of installed systems and reposition TULSA from a cancer‑leaning niche into routine management of lower urinary tract symptoms. The software‑led efficiency pitch is a direct response to operational friction that has limited MRI‑guided therapies: constrained scanner time, multidisciplinary staffing, and variable learning curves. By emphasizing throughput and standardized planning, Profound is targeting the same efficiency arguments that have underpinned adoption of office‑based or ambulatory BPH alternatives such as waterjet resection, convective water vapor therapy, and laser enucleation. The competitive tension is clear: established modalities are already optimized for high‑volume workflows; TULSA’s path to share gain hinges on matching or exceeding that efficiency while sustaining favorable functional outcomes.
For providers and sites, the launch raises practical implications more than technical ones. Hospital radiology and urology services will need to align scheduling, anesthesia, and MR safety protocols to realize the promised same‑day case stacking; sites with underutilized MR capacity may find the economics more compelling than those already operating at scanner saturation. Urology practices without direct MR access will require referral models or hospital partnerships, which could slow community uptake. CROs and sponsors watching device‑enabled prostate trials will note the push toward prospective randomized evidence against surgical standards on the cancer side; comparable rigor versus TURP, aquablation, and other BPH benchmarks will be critical if the module is to influence guidelines and payer coverage. For payers, the argument will center on total episode cost and durability of symptom relief versus established day‑surgery options, not just perioperative metrics.
The next phase will be defined by operational proof points and comparative outcomes. Key markers to watch include published procedure time distributions outside early‑adopter centers, standardized training pathways that reduce variability, and clarity on coding and coverage specifically for BPH volume reduction across Medicare and commercial plans. On the evidence front, head‑to‑head BPH trials with validated quality‑of‑life and retreatment endpoints will determine whether the platform can move beyond niche adoption. If RSNA and SUO presentations confirm consistent performance across settings, and if sites can reliably run multi‑case schedules without disrupting MR throughput, TULSA could become a credible alternative in both oncology and BPH workflows. The unresolved questions are durability, scalability across community sites, and the pace at which AI‑based planning updates will be validated under evolving software change‑control expectations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
