Profound Medical Announces First Commercial BPH Patient Treatment Using TULSA-PRO® with TULSA-AI® Volume Reduction

Core Viewpoint - Profound Medical Corp. has successfully conducted the first commercial treatment for benign prostatic hyperplasia (BPH) using the new TULSA-AI Volume Reduction Module, enhancing the TULSA-PRO system's capabilities for incision-free therapies [1][4]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, AI-powered, incision-free therapies for the ablation of diseased tissue [1][7]. - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology to treat various prostate diseases, including BPH and prostate cancer [8]. Treatment Details - The TULSA procedure is a "one-and-done" treatment that is incision- and radiation-free, performed in a single session lasting a few hours, with no bleeding or hospital stay required [3][8]. - The new TULSA-AI Volume Reduction module streamlines the procedure, allowing for personalized treatment plans and reducing total skin-to-skin time to an expected 60-90 minutes [5][6]. Clinical Efficacy - A recent Phase II study showed significant improvements in urinary function and quality of life for BPH patients treated with TULSA, with the International Prostate Symptom Score (IPSS) decreasing from 17 to 4 and maximum urine flow rate increasing from 11.1 to 18.3 mL/s [4]. - 96% of patients who were on BPH medications prior to the TULSA procedure discontinued their use after treatment [4]. Market Potential - The introduction of the TULSA-AI Volume Reduction module is expected to expand the total addressable market for prostate disease patients from 200,000 to 600,000 annually [7].