1. Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients with Peripheral Artery Disease

    Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients with Peripheral Artery Disease

    Pantheris First-Ever Image-Guided Atherectomy Device Designed to Empower Physicians to Precisely Remove Plaque While Avoiding Disruption of Normal Arterial Wall Structures

    Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for an enhanced version of its Pantheris™ lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. Avinger will commence U.S. commercialization of this enhanced version of Pantheris immediately, which features improved ergonomics, physician controls and manufacturability.

    “I am excited and eager to commercially launch the most recent version of Pantheris. I offer a special thanks to all the patients and investigators who have made this possible,” said John B. Simpson, Ph.D., M.D., the company’s founder and executive chairman. “Our goal has always been to bring to market the most advanced technology for physicians and their patients affected by PAD. With that in mind, we have used the past several months to integrate physician feedback to further improve Pantheris. We are excited to introduce the system to patients and physicians, fulfilling our mission to radically change the treatment of vascular disease.”

    Peripheral artery disease affects nearly 20 million adults in the U.S.[i] and over 200 million people globally.[ii] PAD is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Often dismissed as normal signs of aging, symptoms of PAD include painful cramping, numbness, or discoloration in the legs or feet. PAD can become so severe and difficult to address with traditional treatments that patients and physicians often resort to invasive bypass surgeries, which can result in even greater health risks and lengthy, painful recoveries. In severe cases, patients often face amputation, the worst-case scenario associated with PAD.

    Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology utilized in the Pantheris system allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT. In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the OCT images they see from inside the artery.

    “Atherectomy is a proven treatment that relieves pain and restores blood flow, and Pantheris has been eagerly anticipated in the clinical community because it is a leap forward in atherectomy technology compared to what we have had in the past,” said Thomas Davis, M.D., of St. John Hospital and Medical Center in St. Clair Shores, Michigan. “Now, for the first time, we are able to see exactly where we are removing the plaque, and are better able to leave the healthy artery alone. Clinical data suggests that the precision offered with Pantheris will have a lasting positive effect on patient outcomes. In addition, Pantheris visualizes the artery without requiring ionizing radiation. Thus, OCT has the potential to reduce physician and patient X-ray exposure, which is a concern for all clinicians performing multiple procedures.”

    Pantheris has demonstrated clinical effectiveness and an excellent safety profile. In the recently completed VISION study, 130 patients were treated with Pantheris and followed for a period of six months. The study achieved its primary safety and efficacy endpoints and showed a target lesion revascularization rate of just 8%, and not a single event of vessel perforation, clinically significant dissection or late aneurysm resulted from Pantheris.

    In October 2015, Avinger received 510(k) clearance from the FDA for the Pantheris system for the treatment of patients with PAD. The company subsequently filed a second 510(k) application in December 2015 seeking clearance for an enhanced version of the system, including improved ergonomics, physician controls and manufacturability.

    “Commercialization of Pantheris is a tremendous milestone for Avinger, and the organization has demonstrated exceptional performance against the critical path milestones we established,” said Jeff Soinski, president and CEO of Avinger. “In advance of launching Pantheris, we have continued to increase our installed base of lumivascular accounts and programs to drive utilization, while simultaneously strengthening our sales and marketing infrastructure. I believe we are well positioned to move towards our next stage of growth.”


    About Avinger, Inc.

    Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The company’s mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger’s current lumivascular products include the Lightbox™ imaging console, the Ocelot™ family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris™, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit www.avinger.com.

    "Avinger," “Pantheris” and the Avinger logo are registered trademarks of Avinger, Inc.


    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the clinical utility, expectations for growth and timing for commercial launch of Pantheris. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; ability to demonstrate the benefits of our lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results including our VISION Trial; potential exposure to third-party product liability and intellectual property litigation; lack of long-term data demonstrating the safety and efficacy of our lumivascular platform products; reliance on third-party vendors; dependency on physician adoption; reliance on key personnel; and requirements to obtain regulatory approval to commercialize our products; as well as the other risks described in the section entitled “Risk Factors” in our Form 10-Q filing made with the Securities and Exchange Commission on November 12, 2015. These forward-looking statements speak only as of the date hereof. Avinger disclaims any obligation to update these forward-looking statements.

    [i] The Sage Group releases New Estimates for the United States Prevalence of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI). The Sage Group. September 30, 2010. http://thesagegroup.us/pages/news/pad-cli-new-numbers-10.php.

    [ii] Fowkes FG, Rudan D, Rudan I, et al. “Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis.” Lancet 2013; 382:1329.

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