Profound signs exclusive Saudi Arabia distribution deal

Executive Summary

• Profound Medical Corp. has entered into an exclusive distribution and supply agreement with Al Faisaliah Medical Systems Co. (FMS) for its Tulsa-Pro and Sonalleve technologies in Saudi Arabia.
• FMS is a subsidiary of the Al Faisaliah Group, a prominent business conglomerate in the Kingdom, marking Profound's strategic expansion into the Middle East market.
• The agreement aligns with Profound's strategy of deploying direct sales in North America while partnering with strategic distributors internationally to support commercial growth.

Key Details

• Parties Involved: Profound Medical Corp. (Licensor/Supplier) and Al Faisaliah Medical Systems Co. (FMS) (Licensee/Distributor).
• Territory: Saudi Arabia.
• Products Covered: Exclusive rights for Tulsa-Pro (prostate disease treatment) and Sonalleve (uterine fibroids, adenomyosis, and other oncological applications).
• Strategic Context: Profound is focusing U.S. commercialization of Tulsa-Pro through its direct sales team, while utilizing partners like FMS for international markets.
• Tulsa-Pro Status:
  • Over 4,000 men have undergone the procedure to date.
  • Installed base stands at 67 systems (as of October 2025).
  • CMS issued final rule for three new CPT Category 1 codes effective Jan. 1, 2025, establishing reimbursement at Urology Level 7 APC.
• Sonalleve Status:
  • Currently 10 devices operational in Europe, China, and Southeast Asia.
  • Over 4,000 women treated for adenomyosis and uterine fibroids.
  • Used in research/clinical trials in Europe for pancreatic cancer ablation and other oncological diseases.
  • Approximately $10 million in research grants awarded over the last five years for clinical research.
• Regulatory Approvals:
  • Tulsa-Pro: CE marked, Health Canada approved, and FDA 510(k) cleared.
  • Sonalleve: CE marked for multiple indications; approved by China National Medical Products Administration; FDA approved under humanitarian device exemption for osteoid osteoma.

Notable Quotes

• Arun Menawat, CEO and Chairman, Profound Medical Corp.: "We're honoured 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... 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."
• Abdullah Al Melik, General Manager, FMS: "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... With our partnership with Profound, we're extremely excited to bring its unique, incision- and radiation-free ablative technologies to Saudi hospitals and treatment centres that aim to be worldwide leaders in patient outcomes."