CE Mark Sparks Avinger, Shares Soar 130%

Peripheral Artery Disease (PAD) is a global problem, affecting up to 12 million Americans and 40 million Europeans. The disease, characterized by a narrowing of the peripheral arteries to the legs, stomach, arms, and head, is caused by the silent killer of atherosclerosis that narrows and blocks arteries.

Stents are a common solution for treating blocked arteries, but that doesn't mean they're a full-proof solution. When the artery becomes blocked again at a stent site, it is called "in-stent restenosis."

In-stent restenosis is problematic for doctors due to limitations and complications with today's technologies related to safety and efficacy in treatments.

Medical device company Avinger, Inc. (NASDAQ:AVGR) is building its business around PAD, developing the first-ever image-guided, catheter-based system that diagnoses and treats patients with the disease, a move to reshape the treatment paradigm.

The Redwood City, California-based company has a portfolio of products related to its Lumivascular platform, including the Lightbox imaging console, Ocelot family of chronic total occlusion catheters and Pantheris franchise of atherectomy devices.

In short, the Pantheris Lumivacular atherectomy system gives surgeons are clear view of the artery wall to make more precise cuts to avoid disrupting any healthy tissue of stent construct. Interventionists can now see from inside the artery in real time with the Avinger system, rather than relying on x-rays as tactile feedback.

After lumbering substantially lower throughout 2017 - to the tune of losing about 95% of the stock's value - shares have shot ahead on Wednesday following the company getting a CE Mark for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system.

A CE Mark is the first step in commercializing the system for the tens of millions of patients in the 28-country bloc that includes Germany, Italy, France, Poland and more.

After closing at 21 cents on Tuesday, shares of AVGR blasted as high as 63 cents in Wednesday action, but have chilled back to 48 cents with about an hour left in the trading day, representing a gain of 128.6% so far as the closing bell approaches.