Profound Medical (TSX-V:PRN) has received CE Mark approval for the commercial sale of Tulsa-Pro.
Profound’s novel technology combines real-time magnetic resonance imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control to provide a highly precise treatment tailored to patient-specific anatomy and pathology.
TULSA-PRO has demonstrated accurate and precise ablation of prostate tissue, both malignant and benign, while providing a favorable safety profile and a low rate of erectile dysfunction.
“This is a major step forward in the growth of the company, facilitating the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions,” CEO, Steve Plymale, said in a statement.
“We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with TULSA-PRO,” he added.
Prof. Heinz-Peter Schlemmer of University Hospital of Heidelberg, Germany, one of the lead researchers of a completed Phase 1 clinical trial with TULSA-PRO, said the technology is “excellent for planning, guiding and monitoring focal prostate cancer treatment in order to maximize the therapeutic effect and avoid adverse effects.”
Another lead researcher, Prof. Boris Hadaschik, added that obtaining a CE Mark for TULSA-PRO is an important step forward to broaden the therapeutic offering for localized prostate cancer.
Profound has established subsidiary Profound Medical GmbH in Hamburg, Germany to support European commercial operations. The company said the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will begin immediately.