M&A / Property

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

By The Northwire Desk — AI Analysis Nov 11, 2025 · 16:15 PRN · 9.05 PROFOUND MEDICAL CORP.

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Profound Medical entered an exclusive distribution and supply agreement with Al Faisaliah Medical Systems (FMS) to sell its TULSA‑PRO® and Sonalleve® technologies in Saudi Arabia.
The partnership gives Profound access to the largest healthcare market in the Middle East, aligning with Vision 2030 economic diversification goals.
Both technologies are already approved for import/sale in Saudi Arabia; Profound’s installed base includes 67 TULSA‑PRO systems (4,000+ procedures) and ten Sonalleve devices operating globally.

Agreement Scope: Exclusive rights for FMS to distribute and supply Profound’s MRI‑guided, AI‑powered, incision‑free ablation platforms (TULSA‑PRO® for prostate disease; Sonalleve® for uterine fibroids, adenomyosis, pain palliation, etc.) throughout Saudi Arabia.
Regulatory Status: All required Saudi regulatory approvals are already in place for both technologies.
Commercial Footprint:
TULSA‑PRO: >4,000 men treated; 67 systems installed worldwide as of Oct 2025.
Sonalleve: 10 devices operating in Europe, China, Southeast Asia; >4,000 women treated for uterine conditions; ongoing research trials for pancreatic and other cancers.
Reimbursement Milestone: U.S. CMS final rule effective Jan 1 2025 established outpatient CPT codes and Level 7 APC reimbursement for TULSA procedures.
Strategic Rationale (CEO Quote): “We’re honored to partner with FMS… their deep understanding of regional market dynamics makes them the ideal partner.” – Arun Menawat, CEO & Chairman, Profound Medical.
Partner Statement: FMS GM Abdullah Al Melik highlighted alignment with Saudi Vision 2030 and commitment to delivering advanced oncological and medical technologies.
Market Opportunity: Saudi Arabia represents a high‑growth healthcare market; the agreement positions Profound to capture demand for non‑invasive, radiation‑free ablation therapies.

“Successfully marketing and distributing our incision‑free therapies requires a deep understanding of regional market dynamics… we’re confident that FMS is the ideal partner for us.” – Arun Menawat, CEO & Chairman, Profound Medical Corp.
“We look forward to bringing its unique, incision- and radiation-free ablative technologies to Saudi hospitals and treatment centers…” – Abdullah Al Melik, GM, Al Faisaliah Medical Systems Co.

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