Profound Medical Enters Into Exclusive Distribution Agreement for TULSA-PRO And Sonalleve With Al Faisaliah Medical Systems In Saudi Arabia

Profound Medical Corp

Profound Medical Corp

PROF

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Profound Medical Corp. (NASDAQ:PROF, TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets artificial intelligence ("AI")-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce 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 Co. ("FMS"), a subsidiary of one of the Kingdom's most prominent business conglomerates, Al Faisaliah Group ("AFG").

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.