Profound Medical Inks Exclusive Distribution Agreement for TULSA-PRO® and Sonalleve® with Al Faisaliah Medical Systems in Saudi Arabia

Core Insights - Profound Medical Corp has entered an exclusive distribution agreement with Al Faisaliah Medical Systems Co for its TULSA-PRO and Sonalleve technologies in Saudi Arabia, facilitating access to the Middle East healthcare market [1][6] Company Overview - Profound Medical Corp is a commercial-stage medical device company specializing in AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [9] - The company focuses on two main products: TULSA-PRO for prostate disease and Sonalleve for uterine conditions [4][11] Product Details - TULSA-PRO is designed for treating prostate diseases, utilizing MRI guidance and ultrasound to heat tissue to 'kill temperature' (55-57°C) without incisions or radiation [3][10] - Over 4,000 men have undergone the TULSA Procedure, with 67 TULSA-PRO systems installed as of October 2025 [3] - Sonalleve is primarily sold as a one-time capital sale and is gaining traction outside the U.S., with ten devices operational in Europe, China, and Southeast Asia, treating over 4,000 women for conditions like adenomyosis and uterine fibroids [4][11] Market Strategy - The company is deploying a direct sales team in North America while partnering with strategic distributors globally to enhance market penetration [5] - The partnership with Al Faisaliah Medical Systems is expected to leverage their expertise in introducing advanced medical technologies in Saudi Arabia [6][7] Regulatory and Reimbursement Updates - The U.S. Centers for Medicare & Medicaid Services established reimbursement for the TULSA procedure under the outpatient prospective payment system, effective January 1, 2025 [3] - TULSA-PRO has received necessary regulatory approvals, including CE marking, Health Canada approval, and FDA clearance [10]