EDAP TMS SA, today announced that its Focal One HIFU device has been approved by Health Canada. With this approval, the Company is able to market the Focal One device for the treatment of prostate cancer in Canada.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Health Canada approval of Focal One, our revolutionary tool for the focal treatment of prostate cancer, represents an important milestone for EDAP. Moreover, this is the first regulatory approval for our Focal One device in the Americas, and a key step forward in our overall regulatory strategy as we work to expand Focal One's global footprint and bring our innovative cancer therapies to a growing number of patients worldwide."
Oczachowski continued: "In the 18 months since we received EU marketing approval, the enthusiastic response from the European urology community has validated our belief in the potential of focal therapy for prostate cancer and, more specifically, our Focal One system. In a relatively short time, the technology has been adopted by some of Europe's leading prostate cancer Hospitals. We look forward to a similar reception as we establish our North American presence via the Canadian market."