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Profound Medical Corp. (NASDAQ:PROF, TSX:PRN) (“Profound” or the “Company”), the only company to provide customizable, incision-free therapies which combine real-time Magnetic Resonance Imaging (“MRI”), thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue, today announced Health Canada approval of the TULSA-PRO® system for the ablation of low to intermediate risk organ-confined prostate cancer.
TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men’s functional abilities.
Pursuant to a distribution, license and supply agreement entered into with Knight Therapeutics Inc. (TSX:GUD) (“Knight”) in April 2015, Knight acts as Profound’s exclusive distributor for TULSA-PRO® in Canada. The commercial opportunity for TULSA-PRO® in Canada will be modest until such time that government reimbursement is established.
“The positive Health Canada decision is key to our global expansion strategy for TULSA-PRO®, as many major market jurisdictions, such as China, have a ‘country of origin’ approval requirement for medical devices,” said Goldy Singh, Profound’s VP, Regulatory Affairs & Product Management.
