Twelve-month data from Profound Medical’s (TSXV:PRN) Phase 1 clinical trial of its TULSA-PRO medical device were presented at the European Symposium on Focused Ultrasound Therapy in London.
TULSA is a minimally invasive technology to ablate normal and cancerous prostate tissue, which combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop temperature feedback control.
The primary endpoints of the Phase 1 clinical trial at 12-month follow-up were met, and results support the objectives of conservative whole-gland prostate ablation.
An upcoming pivotal clinical trial will aim to eliminate the safety margin and completely ablate the prostate to the capsule, measuring oncological outcomes while maintaining a similar well-tolerated safety profile.
“The prospective Phase 1 study demonstrated clinical safety and precision of TULSA-PRO for whole-gland prostate ablation, with low toxicity and a well-tolerated safety profile,” CEO, Steve Plymale, said in a statement.
“We are pleased to be moving on to our next milestone of a larger multi-jurisdictional study of 110 patients at 10 clinical trial sites in 2016,” he added.