Mount Sinai Becomes First in Metro New York to Deliver Incision-Free, MRI-Guided Prostate Treatment with TULSA-PRO(TM)

Executive Summary

• Profound Medical announced that Mount Sinai Hospital successfully treated its first prostate cancer patient using the TULSA‑PRO® system.
• The procedure was performed collaboratively by Mount Sinai’s Urology and Interventional Radiology departments, with the patient discharged the same day and responding well.
• The milestone positions Mount Sinai as the first New York Metro health system to offer this AI‑driven, MRI‑guided, incision‑free prostate therapy, supporting future clinical studies and broader adoption of TULSA‑PRO.

Key Details

• First Treatment: Mount Sinai Hospital performed its inaugural TULSA Procedure™ on a prostate cancer patient using Profound’s TULSA‑PRO® system.
• Clinical Outcome: The patient responded well to therapy and was discharged the same day, indicating a successful procedure with no overnight stay.
• Procedure Benefits Highlighted:
• Real‑time MRI thermography for continuous temperature monitoring and autonomous adjustment.
• Robotically controlled directional ultrasound delivers precise heating (55‑57 °C) while protecting surrounding nerves, aiming to preserve urinary continence and sexual function.
• No procedural blood loss, no overnight hospitalization, and rapid return to daily activities.
• Key Participants:
• Dr. Michael Palese (Chair, Dept. of Urology, Mount Sinai Downtown).
• Dr. Neil Rofsky (Chair, Diagnostic, Molecular & Interventional Radiology).
• Drs. Kyrollis Attalla and Christine Chen (Urology & Radiology faculty).
• Executive Comments:
• Arun Menawat, CEO/Chairman of Profound Medical, emphasized the milestone’s significance for AI‑driven prostate care and future guideline development.
• Dr. Ash Tewari, Surgeon‑in‑Chief, Tisch Cancer Hospital, highlighted the addition of a best‑in‑class treatment option for patients.
• Regulatory Status: TULSA‑PRO® is CE marked, Health Canada approved, and FDA 510(k) cleared.

Notable Quotes

“With this milestone, Mount Sinai continues to establish itself as a leader in robotic surgical care, becoming the first health system in the New York Metro Area to offer the innovative, AI-driven, MRI‑guided, and incision‑free TULSA Procedure to prostate disease patients.” – Arun Menawat, CEO & Chairman, Profound Medical

“This unique collaboration … will pave the way for future studies and guidelines in prostate cancer and BPH using TULSA‑PRO.” – Ash Tewari, MD, Surgeon‑in‑Chief, Tisch Cancer Hospital & System

Materiality Assessment: Material – Positive (first commercial use at a leading U.S. academic hospital, demonstrating clinical adoption and supporting future growth of Profound’s flagship product).