Less-invasive prostate cancer treatment receives FDA clearance
AA-S July 4th, 2018
by Nicole Cobler <email@example.com>
French company EDAP TMS, which made Austin its U.S. headquarters two years ago, has received U.S. Food and Drug Administration clearance for "Focal One" - a treatment for prostate cancer using high-intensity focused ultrasound.
Brian Miles, a urologist at Houston's Methodist Hospital, said the facility is aiming to be the first U.S. site to house the technology.
"I see this being embraced substantially in Texas now that Focal One has been accepted," he said. "I think it will really become a standard therapy."
Miles said Focal One allows him to destroy a targeted area rather than remove the entire prostate, which can increase the risk of side effects like erectile dysfunction and urinary incontinence. Men with localized prostate cancer, meaning only contained in the prostate, are eligible for the procedure.
"The Focal One device by comparison will allow me to take a mouse and outline the area that I want treated," Miles said, adding that the machine then takes over.
According to the U.S. Centers for Disease Control, prostate cancer is the leading cancer diagnosed in men each year in the country.
Prostate cancer patients in the U.S. can already access high-intensity focused ultrasound treatments similar to Focal One, but the method is often costly and not well-known, Miles said. The two focused ultrasound systems approved in the U.S. for destruction of prostate tissue are EDAP's first generation Ablatherm and now Focal One and SonaCare's Sonablate.
Sonablate and Ablatherm received FDA approval in 2015.
More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer, according to the Prostate Cancer Research Institute.
Miles expects the updated technology to "open up a new door," where men can be treated for prostate cancer and leave the hospital hours later with fewer side effects.
And Hugo Embert, the CEO of the company's U.S. headquarters, said high-intensity focused ultrasound gives men the option to undergo the procedure again if the cancer comes back.
"The early results are very encouraging, but in case the cancer returns a few years down the road, you still have the possibility of offering everything you could've offered in the first place" such as surgery to completely remove the prostate or radiation, Embert said.
The FDA clearance could mean growth in Austin. Embert expects the Austin office to "grow significantly" in the future with the approval of Focal One. Currently, there are 10 employees in Austin, part of a 15-member team across the country.
"This is just the beginning," Embert said.
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