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Profound Medical (NASDAQ:PROF) will unveil its new TULSA‑AI Volume Reduction module for benign prostatic hyperplasia (BPH) at the Radiological Society of North America (RSNA) meeting in Chicago, Nov. 30–Dec. 4, 2025, and will present updated TULSA‑PRO clinical data at both RSNA and the Society for Urologic Oncology (SUO) meeting, Dec. 2–5, 2025.
The AI‑enhanced module is positioned as a workflow optimizer that shortens procedure times, enables multiple same‑day BPH cases with the existing TULSA‑PRO platform, and leverages current reimbursement codes. Profound cites a pilot trial and its CAPTAIN peri‑operative study, which reportedly show lower blood loss, shorter hospital stays, reduced post‑operative pain, and faster recovery compared with robotic prostatectomy. The company estimates a potential addressable market of roughly 600,000 prostate‑disease patients per year.
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Insights
Profound’s AI‑driven BPH module and fresh clinical data point to a potential commercial expansion of its TULSA platform.
The new TULSA‑AI Volume Reduction add‑on lets physicians treat enlarged prostates using the same TULSA‑PRO hardware, staff and billing pathways. By automating treatment planning and temperature monitoring, the system claims to reduce case time enough to stack several BPH procedures in a single day.
Adoption will hinge on three factors: clinician acceptance of the AI workflow, reproducibility of the pilot outcomes in real‑world settings, and payer recognition of the claimed efficiency gains. The company’s projection that the module could “triple” its total addressable market to roughly 600,000 patients annually is forward‑looking and should be viewed as a strategic target rather than a guaranteed outcome.
Key clinical claims stem from the CAPTAIN trial, which compares TULSA‑PRO with robotic radical prostatectomy on peri‑operative metrics such as blood loss, length of stay, post‑op pain and convalescence. If these advantages hold up in broader practice, they could drive a shift toward MRI‑guided, incision‑free therapies across the prostate‑disease spectrum.
Investors should monitor the following milestones over the next 12 months:
- Publication of full pilot‑trial results and validation of procedural time reductions.
- Peer‑reviewed CAPTAIN data confirming peri‑operative superiority.
- Real‑world procedure volume reports from early‑adopter sites.
- Reimbursement policy updates that incorporate the AI‑enabled workflow.
RSNA sessions (Nov. 30–Dec. 4) and SUO presentations (Dec. 2–5) will provide the first public look at the data, with detailed abstracts expected in upcoming medical journals.
New BPH module underscores the versatility of the TULSA Procedure™ across prostate disease, promising superior patient outcomes and broader market adoption.
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) develops AI‑powered, MRI‑guided, incision‑free therapies for ablating diseased tissue. The company announced the upcoming launch of its TULSA‑AI® Volume Reduction module, designed to streamline treatment of benign prostatic hyperplasia (BPH), at the RSNA meeting in Chicago, Nov. 30–Dec. 4, 2025.
BPH, a non‑cancerous enlargement of the prostate, affects a large proportion of aging men, leading to urinary obstruction and lower urinary tract symptoms. Conventional transurethral resection of the prostate (TURP) has changed little in a century, while newer modalities aim to reduce bleeding, preserve sexual function, and shorten hospital stays.
The TULSA Procedure™, delivered via the TULSA‑PRO® system, is currently the only incision‑free approach approved for prostate cancer, BPH, and hybrid indications. The AI‑driven volume‑reduction module integrates with this platform, allowing physicians to treat multiple BPH cases in a single session without additional equipment or billing changes. Real‑world data have shown lower rates of sexual dysfunction and incontinence, while the CAPTAIN peri‑operative study suggests superiority over robotic prostatectomy in blood loss, length of stay, post‑operative pain and recovery time.
“The AI workflow shortens procedure time and brings the TULSA‑PRO system on par with other modern BPH treatments, while preserving the precision of MRI‑guided ablation,” said Arun Menawat, CEO and Chairman of Profound. “We expect these efficiencies to accelerate adoption and expand our addressable market to roughly 600,000 patients annually.”
In addition to the BPH announcement, Profound will present new TULSA‑PRO data for prostate cancer at both RSNA and SUO in Phoenix, Dec. 2–5, 2025.
RSNA Event Details
- Booth #3153, South Hall A – live demonstrations of the TULSA‑AI Volume Reduction module and case studies from the pilot launch.
Key Sessions
- “CAPTAIN Randomized Controlled Trial of MRI‑Guided Transurethral Ultrasound Ablation vs. Robotic Radical Prostatectomy,” Dr. Pejman Ghanouni, Stanford, Dec. 1, 12:15 p.m. CST, Learning Center.
- “Discover TULSA‑PRO: AI‑Powered MRI‑Guided Precision Prostate Ablation,” Dr. Daniel Costa (MD Anderson) and Dr. Joseph Busch (The Busch Center), Dec. 2, 11:30 a.m. CST, Innovation Theatre, Booth 3316.
- “MR‑Guided Transurethral Ultrasound Ablation: Outcomes in 160 Organ‑Confined Prostate Cancer Patients,” Dr. Joseph Busch, Dec. 2, 1:30 p.m. CST, Room E352.
SUO Event Details
- Booth – overview of TULSA applications across the prostate‑disease spectrum.
Featured Presentation
- “Randomized Controlled Trial Evaluating MRI‑Guided Transurethral Ultrasound Ablation vs. Robotic Prostatectomy,” Dr. Geoffrey Sonn, Stanford, Dec. 5, 2:30–3:30 p.m. MST.
Company Background
Profound Medical commercializes TULSA‑PRO®, a technology that blends real‑time MRI, AI‑enhanced treatment planning, robotically driven transurethral ultrasound and closed‑loop temperature feedback. The system can treat virtually any prostate size or shape, eliminates intra‑operative bleeding, requires no hospital admission, and offers rapid return to normal activities. TULSA‑PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA.
In addition to TULSA, Profound markets Sonalleve®, an MR‑guided high‑intensity focused ultrasound platform approved for uterine fibroids, adenomyosis, bone‑metastasis pain palliation, desmoid tumors, and osteoid osteoma. The company is exploring broader oncology indications, including non‑invasive ablation of abdominal cancers and hyperthermia‑enhanced radiotherapy.
Strategic Outlook
The introduction of the AI‑driven BPH module aligns with a broader industry trend toward digitized, data‑rich procedural workflows. By leveraging AI for automated segmentation, treatment planning and temperature monitoring, Profound can lower operator dependence and potentially reduce training time for new adopters. If the claimed reductions in case duration translate into higher procedural throughput, hospitals could improve operating‑room utilization while offering patients a less invasive alternative to TURP or robotic surgery.
From a commercial perspective, the module’s ability to use existing TULSA‑PRO hardware and reimbursement pathways reduces capital barriers, making it attractive to midsize and large health systems alike. However, widespread uptake will be contingent on payer coverage decisions, demonstrable cost‑effectiveness, and sustained clinical evidence that backs the peri‑operative advantages highlighted in the CAPTAIN study.
Analysts will be watching for:
- Peer‑reviewed publication of CAPTAIN and pilot data.
- Reimbursement coding updates that recognize the AI‑enabled workflow.
- Adoption rates at leading academic centers and community hospitals.
- Competitive response from other MRI‑guided or HIFU platforms.
11/28/2025 – 07:45 AM
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