News | Prostate Cancer | April 04, 2017

Profound Medical Corp. Announces First Paid Procedure Using TULSA-PRO System

System that combines real-time MRI with transurethral, robotically-driven therapeutic ultrasound employed for the first time in Germany

April 4, 2017 — Profound Medical Corp. announced that the first TULSA-PRO patient paid procedure has been successfully conducted at the ALTA Klinik in Bielefeld, Germany under the supervision of Agron Lumiani, M.D.

TULSA-PRO combines real-time magnetic resonance imaging (MRI) with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. The technology has demonstrated accurate and precise ablation of malignant prostate tissue, while providing a favorable safety profile, with low rates of serious or long-term adverse events.

The procedure was administered by Lumiani, founder of the ALTA Klinik, a leading German radiologist and an early adopter of MRI diagnostics and MRI-targeted prostate biopsy. Lumiani intends to leverage TULSA technology for focal therapy in the treatment of patients with localized prostate cancer, and also believes that TULSA-PRO holds promise for ablation in other prostate conditions.

“ALTA was established as a state-of-the-art clinic offering the most innovative diagnostic procedures and treatments,” commented Lumiani. “MRI continues to become a more trusted tool for diagnostics and biopsy of prostate cancer.  Since 2009, the clinic has specialized in MRI diagnostics and MRI-targeted prostate biopsy. Profound’s TULSA-PRO system aligns well with this concept, now enabling treatment under real-time MR guidance and control. TULSA-PRO can complete this paradigm shift, potentially offering patients a therapy that is safe and effective, with minimal side effects. I am optimistic about the technology and look forward to making it available to our patients.”

Profound is currently conducting a pilot commercial launch of TULSA-PRO in key European and other CE mark jurisdictions. The company is also sponsoring a multicenter, prospective U.S. Food and Drug Administration (FDA)-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology. If successful, TACT is expected to support Profound's application to the FDA for approval to market TULSA-PRO in the United States.

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