Profound Medical Corp.

We are a commercial-stage medical device company focused on developing and marketing AI-powered, MRI-guided, incision-free therapies for ablating diseased tissue using our platform technologies. Our main product, the TULSA-PRO system, integrates real-time MRI, robotically-driven transurethral sweeping action/thermal ultrasound, and closed-loop temperature feedback control to ablate either the entire gland or a physician-defined region of malignant or benign prostate tissue. The TULSA-PRO system has demonstrated effectiveness in clinical and commercial settings for physicians treating prostate diseases, including cancer and benign prostatic hyperplasia ("BPH"). In August 2019, the TULSA-PRO system received FDA clearance as a Class II device in the United States for thermal ablation of prescribed prostate tissue, based on the Company's TACT whole gland ablation pivotal study. It also holds CE Mark approval in the EU for ablation of targeted prostate tissue (benign or malignant) and was approved by Health Canada in November 2019. Our Sonalleve system is CE Marked in the EU for ablation of uterine fibroids and adenomyotic tissue, palliative pain relief for bone metastases, treatment of osteoid osteoma, and management of benign desmoid tumors. The Sonalleve system is also approved in China and South Korea for non-invasive treatment of uterine fibroids. In November 2020, the Sonalleve system received HDE approval from the FDA for treating osteoid osteoma in the extremities. Our systems are designed for use with MRI scanners and are currently compatible with select MRI scanners from Philips, Siemens, and GE Healthcare. We have generated revenues from commercializing our systems in the United States, EU, and Asia.