Profound Medical upbeat about Busch Center results

Executive Summary

• Profound Medical Corp. released real-world data from the Busch Center marking the 500th completed Tulsa Procedure, highlighting the versatility and success of the incision-free, MRI-guided treatment for a broad spectrum of prostate diseases.
• The data demonstrates high efficacy in treating prostate cancer (primary and salvage) and benign prostatic hyperplasia (BPH), with specific success in complex cases involving high-risk disease, large prostate volumes, and lesions abutting the urinary sphincter.
• Clinical outcomes reported include significant PSA reduction, high rates of cancer control without residual disease, and the preservation of urinary continence and erectile function, supporting the technology's precision and safety profile.

Key Details

• Milestone: The Busch Center completed its 500th Tulsa Procedure.
• Procedure Scope: The Tulsa Procedure treats prostate cancer and benign prostatic hyperplasia (BPH) using an incision-free, MRI-guided, robotically driven approach.
• Case Breakdown at Busch Center:
  • Approximately 50% of cases were for the primary treatment of prostate cancer.
  • Approximately 33% (one-third) were for BPH, either alone or co-occurring with prostate cancer.
  • The remainder were salvage patients previously treated with other therapies.
• Treatment Specifics:
  • Over three-quarters of cases involved customized ablations covering more than 90% of the prostate volume.
  • The majority of prostate cancer patients were intermediate risk; however, more than 15% had high-risk disease.
  • Two-thirds of treated prostates were over 40 cubic centimeters (cc), with volumes reaching up to 250 cc.
• Clinical Outcomes (Retrospective Analysis of 73 Patients):
  • PSA Reduction: Reduced from 6.7 ng/mL to 0.9 ng/mL.
  • Cancer Control: No evidence of residual disease in 93% of patients with prostate cancer abutting or involving the external urinary sphincter.
  • Functional Preservation: Despite treating up to 50% of the external sphincter, pad-free continence was maintained in 100% of men, and erectile function was maintained in 82% of men.
• Technology Features:
  • Utilizes real-time thermography for precision control.
  • Includes AI modules like "Thermal Boost."
  • Combines urethral cooling and high-frequency mode to tightly control margins near sensitive structures.
• Regulatory Status: Tulsa-Pro is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA.

Notable Quotes

• "When I first began performing the Tulsa Procedure, I was optimistic but cautious. After about 30 procedures, I was confident enough to offer Tulsa to my patients exclusively... I have had highly successful outcomes, even in the more complicated cases, such as those involving cancer at the prostate apex or calcifications that can make treatment more challenging." — Dr. Joseph Busch, Founder of the Busch Center
• "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... we're seeing encouraging results in diverse patient populations that point to the Tulsa Procedure as a precise, customizable, next-generation treatment for most men with prostate disease." — Arun Menawat, CEO and Chairman of Profound Medical Corp.