Profound Medical Congratulates the Busch Center for Achieving 500th TULSA Procedure Milestone

Executive Summary

• Profound Medical unveiled real‑world data from the Busch Center marking its 500th TULSA Procedure, demonstrating broad efficacy across prostate cancer and BPH indications.
• Outcomes show high rates of continence (100%) and erectile function preservation (82%), with PSA reductions from 6.7 ng/mL to 0.9 ng/mL in patients treated near the external urinary sphincter.
• The data reinforce TULSA‑PRO’s positioning as a customizable, incision‑free, MRI‑guided therapy for a wide spectrum of prostate disease, supporting continued commercial expansion.

Key Details

• Milestone: 500 completed TULSA Procedures™ at the internationally recognized Busch Center.
• Case Mix: ~50% primary prostate cancer treatment, ~33% BPH (alone or with cancer), remainder salvage therapy after prior treatments.
• Procedure Scope: >75% of cases involved whole‑gland ablations covering >90% of prostate volume; two‑thirds treated prostates ≥40 cc, up to 250 cc.
• Risk Profile: Majority intermediate‑risk patients; >15% high‑risk disease benefitted from intra‑operative MRI guidance and TULSA‑AI® modules (e.g., Thermal Boost).
• Clinical Outcomes:
• PSA reduction from 6.7 ng/mL to 0.9 ng/mL in a retrospective cohort of patients with lesions abutting the external sphincter.
• No residual disease detected in 93% of these patients.
• Pad‑free continence maintained in 100%; erectile function preserved in 82%.
• Safety: No life‑altering complications reported; no urinary incontinence or erectile dysfunction attributable to the procedure in the highlighted cohort.
• Technology Highlights:
• AI‑powered, MRI‑guided robotic system (TULSA‑PRO®) delivering directional transurethral ultrasound with real‑time thermography and urethral cooling.
• Ability to treat prostate volumes from <40 cc up to >250 cc, including extreme apex lesions.
• Regulatory Status: TULSA‑PRO is CE marked, Health Canada approved, and FDA 510(k) cleared.

Notable Quotes

“Dr. Busch’s experience reflects both his surgical expertise and the flexibility of the TULSA‑PRO technology in addressing a broad spectrum of prostate disease and disease severity,” – Arun Menawat, CEO & Chairman, Profound Medical Corp.

“When I first began performing the TULSA Procedure, I was optimistic but cautious… I’ve had many men referred to me by previous patients who had positive results, including good cancer control and no side effects like urinary incontinence and/or erectile dysfunction,” – Dr. Joseph Busch, Founder, Busch Center.