Avinger (AVGR) Stock Heads For The Top On FDA Clearance

Avinger AVGR Stock News

Avinger Inc (NASDAQ: AVGR) is rocketing in the market this morning, and for good reason. The comapny announced an FDA approval, exciting investors. Here’s what’s happening:

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

AVGR Announces FDA Clearance

In the press release, Avinger said that it recieved 510(k) clearance from the United States Food and Drug Administration (FDA). The clearance surrounds the company’s next generation image-guided chronic total occlusion (CTO) crossing system known as Ocelaris.

In the release, AVGR said that the device will be marketed under the brand name, TIGEREYE. The name was chosen to reinforce the products highly differentiated benefit of providing real-time imaging from inside the vessel during CTO-crossing procedures.

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 TIGEREYE, which we believe will be a significant growth driver for our CTO-crossing business. Our Ocelot catheters have helped physicians cross thousands of CTOs since introduction of the product line in 2013. TIGEREYE brings compelling new features and benefits to expand upon this platform to help physicians safely cross challenging CTOs. We anticipate initiating a limited launch of TIGEREYE in the U.S. in the fourth quarter of this year, then leveraging our growing commercial infrastructure and installed base of Lumivascular accounts for national launch in early 2021.

The above statement was followed up by Dr. Jaafer Golzar, CMO at Avinger. Here’s what he had to say:

I believe that TIGEREYE represents a major advancement for patients with chronic total occlusions, which presents one of the most significant technical challenges to physicians treating peripheral artery disease. By combining real-time intravascular imaging and the ability to precisely control the device within the vessel, TIGEREYE provides an important new tool to help interventionalists stay within the true lumen while successfully crossing these challenging lesions. Intraluminal crossing provides for a wider variety of treatment options following crossing of the CTO and results in less potential for vascular injury, which has been shown to improve long-term clinical outcomes for patients.

The FDA clearance of TIGEREYE provides another market growth opportunity for Avinger, further building on the market gains we have made with our Pantheris Next Generation and Pantheris SV catheters. TIGEREYE will be the third new product released by Avinger in less than 3 years, putting us on the leading edge of innovation for PAD therapy. We have grown our commercial sales team and advanced our clinical studies to drive case activity and build data in support of our image-guided approach. The Company has a robust pipeline of new products and a strong balance sheet with more than $25 million in cash to fuel our product launch and growth plans.

This News Is Huge

The news released by Avinger proved to be overwhelmingly positive. After all, 510(k) clearance means that the company now has the ability to market its product throughout the United States. As a result, the company may drive strong revenue from TIGEREYE ahead.

Moreover, in management quotes, we saw the team pointing to a strong balance sheet. With more than $25 million in the bank, the company has the money it needs to move forward with aggressive marketing campaigns, only further expanding the opportunity here. As such, AVGR stock is one to watch closely.

Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!

Don’t Miss The Next Big Story

Join our free mailing list below to receive real-time news alerts!

Subscribe Today!

* indicates required

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.