Shares in Edap (NSDQ:EDAP) rose 59% today after the medical device company announced that its Focal One HIFU device was approved by Health Canada, giving it the go ahead to market the device for the treatment of prostate cancer in Canada.
Edap shares rose $1.38 to $3.70 in heavy morning trading. More than 3 times the 10-day average of shares changed hands.
"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," CEO Marc Oczachowski said in prepared remarks.
"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," Oczachowski said.
Last November the FDA sent Edap a “not approvable” letter for its Ablatherm prostate cancer treatment, after 1 of the watchdog agency’s advisory panels in July voted against recommending approval for the device.
That decision prompted Edap shareholders to sue the company and its management for allegedly misleading investors.
Material from Reuters was used in this report.
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