EDAP Wins Big With FDA Clearance

By Chris Lange Updated Jan 11, 10:36PM EST · Published Jun 8, 10:56AM EDT

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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.

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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.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.