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].

Core Insights - Profound Medical Corp has entered a consulting agreement with Leonard Wheeler, a former NFL player, to enhance awareness and advocacy for its TULSA-PRO system, a treatment for prostate cancer [1][2][10] - The TULSA procedure is a non-invasive, AI-powered therapy that utilizes real-time MRI guidance and sound absorption technology to treat prostate tissue while preserving urinary continence and sexual function [7][12] Company Overview - Profound Medical Corp is a commercial-stage medical device company focused on developing customizable, incision-free therapies for the ablation of diseased tissue [11] - The company is commercializing the TULSA-PRO system, which is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA [12] Product Details - The TULSA procedure is designed for a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [7][12] - The procedure is performed in a single session, takes a few hours, and does not require hospitalization, with most patients reporting a quick recovery [7][12] Partnership and Advocacy - Leonard Wheeler, who underwent the TULSA procedure, will create platforms to educate and empower men regarding prostate health and the TULSA-PRO system [2][8] - The partnership aims to launch a comprehensive awareness campaign utilizing digital media, social media, and podcasting to reach a broader audience [10]