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Profound Medical to Launch AI-Powered BPH Module, Present New TULSA-PRO(TM) Clinical Data, at RSNA and SUO Meetings

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Executive Summary
- Profound Medical announced the upcoming launch of its TULSA‑AI® Volume Reduction module for benign prostatic hyperplasia (BPH) at the RSNA meeting in Chicago (Nov 30–Dec 4, 2025).
- The new AI‑driven module is intended to streamline workflow, reduce procedure times, and expand the addressable market for TULSA‑PRO® to an estimated 600,000 patients annually.
- Additional clinical data on TULSA‑PRO for prostate cancer will be presented at RSNA and the Society for Urologic Oncology (SUO) conference in early December.
Key Details
- Launch Venue & Timing: RSNA meeting, Chicago, Nov 30–Dec 4, 2025; booth #3153, South Hall A for live demonstrations.
- Product Focus: TULSA‑AI Volume Reduction module – AI‑enhanced planning to enable multiple BPH cases per day using existing hardware and reimbursement codes.
- Clinical Rationale: Builds on pilot trial results showing reduced sexual dysfunction, incontinence, blood loss, length of stay, post‑op pain, and faster recovery versus robotic prostatectomy (CAPTAIN trial).
- Market Impact Statement: CEO Arun Menawat expects the module to triple Profound’s total available market for prostate disease to ~600,000 patients per year.
- Additional Presentations:
- RSNA: “CAPTAIN Randomized Controlled Trial of MRI‑Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy” – Dec 1.
- RSNA: “Discover TULSA‑PRO: AI‑powered MRI‑guided Precision Prostate Ablation” – Dec 2.
- SUO (Phoenix, Dec 2–5): New data on TULSA‑PRO for prostate cancer; presentation by Dr. Geoffrey Sonn on Dec 5.
- Company Portfolio Reminder: Profound also markets Sonalleve® for uterine fibroids, adenomyosis, bone metastasis pain palliation, desmoid tumors, and osteoid osteoma, with CE marking, Health Canada approval, FDA 510(k) clearance, and Chinese NMPA approval where applicable.
Notable Quotes
- “We’re confident to launch the TULSA‑AI Volume Reduction module for BPH, following a successful pilot trial earlier this year… We expect the reduced procedure times will increase adoption of the TULSA Procedure and triple Profound’s total available market in prostate disease to about 600,000 patients annually.” – Arun Menawat, CEO & Chairman.
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