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

Profound Medical Corp., an emerging medical device company focused on prostate care, announced that the first TULSA-PRO patient paid procedure has been successfully conducted at the ALTA Klinik (ALTA) in Bielefeld, Germany, under the supervision of Dr. Agron Lumiani.
 
TULSA-PRO combines real-time magnetic resonance imaging (MRI) with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control designed 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 favourable safety profile, with low rates of serious or long-term adverse events.
 
The procedure was administered by Lumiani, founder of the ALTA Klinik, a 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.”
 
“This is a great step forward in Profound’s journey to commercialize the TULSA-PRO system in Europe and build awareness about the technology as an attractive clinical option for patients with localized prostate cancer,” said Arun Menawat, Profound’s CEO. “We also believe it will act as a strong catalyst for further adoption of the therapy as we continue our penetration into other European and international markets. We look forward to working with Dr. Lumiani to address the unmet needs of patients who suffer from this disease.”
 
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 the technology. If successful, TACT is expected to support Profound’s application to the FDA for approval to market TULSA-PRO in the United States.
 
Established in 2008, Profound Medical is commercializing TULSA-PRO, which combines real-time MRI with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO is CE Marked and Profound is sponsoring a multicenter, prospective FDA-registered clinical trial, TACT. Profound Medical is based in Ontario, Canada.