Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) has announced that it has entered into an exclusive distribution and supply agreement for its TULSA-PRO and Sonalleve technologies in Saudi Arabia with Al Faisaliah Medical Systems (FMS), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (AFG).
In a statement, Arun Menawat, CEO and chairman of Profound, commented, “We’re honored to partner for the distribution of both TULSA-PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia. Successfully marketing and distributing our incision-free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients. With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we’re confident that FMS is the ideal partner for us.”
Mr. Abdullah Al Melik, GM of FMS, remarked, “As Saudi Arabia moves toward economic diversification under Vision 2030, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country’s future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities. With our partnership with Profound, we’re extremely excited to bring its unique, incision- and radiation-free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team.”
Profound is the only company that combines the real-time imaging and thermography capabilities of magnetic resonance (MR) with AI-driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay.
U.S. commercialization of TULSA-PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, BPH), remains the top priority for the company’s direct sales team. The TULSA Procedure™, performed using Profound’s TULSA-PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55-57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention-to-treat, while TULSA-PRO has the flexibility to be used for all ablations, including focal and hemi-gland, the majority of TULSA Procedures are either whole-gland or near-whole-gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (Final Rule) for the three new CPT Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To-date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (October 2025), Profound’s TULSA-PRO installed base stood at 67 systems.
Profound’s second product, Sonalleve, which is offered primarily as a one-time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA-PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life-threatening diseases.
As user interest in Profound’s technologies continues to build, the company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.
