Confidentially Marketed Public Offering
Avinger is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral artery disease, or PAD. Avinger manufactures and sells a suite of products in the United States and select European markets. Avinger’s current products include the Lightbox imaging console, as well as the Wildcat, Kittycat, and the Ocelot family of catheters, which are designed to allow physicians to penetrate a total blockage in an artery, known as a chronic total occlusion, or CTO, and Pantheris, the Company’s image-guided atherectomy device, designed to allow physicians to precisely remove arterial plaque in PAD patients. In October 2015, Avinger received 510(k) clearance from the FDA for commercialization of Pantheris, and in March 2016 received FDA approval for an enhanced version of Pantheris, and promptly thereafter we commenced sales of Pantheris in the U.S. and in select European countries. Avinger began commercializing its initial non-Lumivascular platform products in 2009 and introduced the Lumivascular platform products in the United States in late 2012.