EDAP Wins Big With FDA Clearance

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EDAP TMS S.A. (NASDAQ: EDAP) shares saw an incredible gain to close out the week after the company announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for the ablation of prostate tissue.

For some quick background: the Focal One high-intensity focused ultrasound (HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate. Focal One fuses MR and 3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate on a large monitor and direct high-intensity ultrasound waves to ablate the targeted area.

With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and minimizes side effects of incontinence and impotence for patients.

Dr. Brian Miles, urologist, professor of Urology, Houston Methodist Hospital – Weill Cornell Medical College, commented:

Focal One is a great step forward in using this new and important ultrasound technology for prostate tissue ablation. Focal One’s ability to merge MRI images, ultrasound images and biopsy data in order to precisely outline and treat just the diseased tissue area of the prostate is truly remarkable.

Shares of EDAP were last seen up about 60% at $3.53, with a consensus analyst price target of $5.25 and a 52-week range of $2.07 to $4.25.