Avinger Inc (NASDAQ: AVGR) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced an FDA clearance, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The FDA clearance;
- what we’re seeing from AVGR stock as a result; and
- what we’ll be watching for ahead.
AVGR Announces FDA Clearance
As mentioned above, Avinger is having a great day in the market today after announcing FDA news. In a press release issued early this morning, the company announced that it has received 510(k) clearance from the FDA.
The marketing clearance surrounds the company’s Pantheris SV image-guided atherectomy system. AVGR reminded investors that Pantheris SV is a product line extension of its Lumivascular image-guided atherectomy platform.
Through the clearance, the company expects to expand the available market for Pantheris by up to 50%. Moreover, the clearance allows the company to address a larger portion of the estimated $500 million atherectomy market.
The company also reminded investors that Pantheris SV received CV Marking in October of 2018 and the first patients were treated with the device in Germany in November. Moving forward, the company plans on initiating a limited launch of Pantheris SV in several sites in the United States when commercial product is available.
In a statement, Jeff Soinski, President and CEO at AVGR, had the following to offer:
We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%.
With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Avinger, the news proved to be incredibly positive.
At the end of the day, the 510(k) clearance gives the comapny the ability to market the device in the United States. Of course, this will likely open the door to revenue growth.
Considering this, it’s not surprising to see that excited investors are pushing the stock for the top in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:50), AVGR is trading at $1.18 per share after a gain of $0.26 per share or 28.96% 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 story surrounding the company’s continued work to expand sales through this 510(k) approval. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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