Profound Medical receives CE Mark for minimally invasive therapy in prostate care

Profound Medical announced that the company has received CE Mark approval for the commercial sale of TULSA-PRO.

“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. 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. 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,” said Steve Plymale, CEO.

Profound’s novel technology combines real-time Magnetic Resonance (MR) imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control, providing 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 favourable safety profile and a low rate of erectile dysfunction.

Profound Medical GmbH, a subsidiary of Profound Medical Corp., has been established in Hamburg, Germany to support European commercial operations. The commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will commence immediately.

Product information can be found from Profound Medical website by clicking here.