Avinger Inc (NASDAQ: AVGR) is having an overwhelmingly strong start to the trading session this morning after announcing FDA news. In fact, the company announced that one of its products has received clearance from the United States Food and Drug Administration (FDA). Of course, the ability to market a new product is exciting investors, leading to gains in the stock. 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 AVGR ahead.
AVGR Announces FDA Clearance
As mentioned above, Avinger is having an incredibly strong start to the trading session this morning after the company announced news surrounding clearance from the FDA. In a press release issued early this morning, the company announced that it has received 510(k) clearance from the FDA for its next generation Pantheris® Lumivascular atherectomy system. The system is the first-ever-image-guided atherectomy device that was designed and approved for the treatment of peripheral artery disease.
In the release, AVGR said that Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. This isn’t the only good news the company has seen as of late surrounding its Pantheris® Lumivascular atherectomy system. In fact, back in December of last year, the device also received CE Marking approval, and there have already been patients successfully treated with the new device in Germany since the approval.
In a statement, Mr. Jeff Soinski, President and CEO at AVGR, had the following to offer:
We are excited to introduce the next generation Pantheris to our network of physicians here in the United States… After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations.
The above statement was followed up by Dr. Barry Tedder, M.D., Interventional Cardiologist at St. Bernards Medical Center in Jonesboro, Arkansas. Here’s what he had to say about the newly approved AVGR device:
The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure.
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 this particular case, the news proved to be overwhelmingly positive. With the clearance from the FDA in the United States, Avinger now has the ability to market the Pantheris® Lumivascular atherectomy system in the United States. This will likely drive strong revenue ahead. So, it’s no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:09), AVGR is trading at $1.93 per share after a gain of $0.64 per share (49.61%) 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 AVGR. In particular, we’re interested in following the sales of the Pantheris® Lumivascular atherectomy system and the revenue generated now that the company has approval to move to the commercialization stage. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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