Edap Tms SA (ADR) (NASDAQ: EDAP) is soaring in the market this morning, and for good reason. The company announced that it has received 510(k) clearance from the United States Food and Drug Administration surrounding it’s flagship medical device. Of course, the news of the clearance led to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about:
- The FDA clearance;
- what we’re seeing from the stock as a result;
- and what we’ll be watching for with regard to EDAP ahead.
EDAP Announces FDA Clearance
As mentioned above, Edap is having an incredibly strong start to the trading session this morning after announcing FDA news. In a press release issued early this morning, the company announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Focal One device for the ablation of prostate tissue. Focal One is a high intensity focused ultrasound (HIFU) device develped by EDAP. It is the first medical device that is designed specifically for focal treatment of the prostate.
By combining MR and 3D biopsy data with real time ultrasound imaging, Focal One allows urologists to view integrated, detailed 3D images of the prostate on a large monitor. From there, high intensity ultrasound waves are directed in order to ablate the target area. In the release, the company said that with Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. As a result, the potential damage to healthy tissue is minimize, ultimately minimizing the side effects of incontinence and impotence for patients. In a statement, Marc Oczachowski, CEO at EDAP, had the following to offer:
We are thrilled that this innovative technology will now be available to patients and physicians in the United States… The FDA’s clearance of Focal One validates not only the power of our technology but also the years of hard work and dedication by our clinical trial investigators and EDAP’s outstanding employees. Focal One’s real-time imaging and 3D robotic features allow for greater precision, leading to improved targeting and treatment planning, and we are excited to be able to expand access to Focal One to the most important healthcare market in the world.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dabble in the market is that the news causes moves. In the case of Edap, the news proved to be overwhelmingly positive. After all, with the FDA Clearance announced today, the company is now free to commercialize the Focal One device, ultimately driving revenue in the process. So, it’s no surprise to see that the stock is running for the top in the market this morning. At the moment (7:55), EDAP is trading at $3.83 per share after a gain of $1.62 per share or 73.30% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on EDAP. In particular, we’re interested in following the story surrounding the commercialization of Focal One and excited to see the revenue it generates. Nonethelss, we’ll continue to follow the story closely and bring the news to you as it breaks!
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