Avinger Announces First Patients Enrolled in Post-Market Study Comparing Pantheris OCT Imaging to Intravascular Ultrasound

Published: Jun 14, 2018

Avinger, Inc. (AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the initiation of the SCAN study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. OCT is a light-based, high definition imaging modality, which generates no X-ray radiation. Avinger’s proprietary Lumivascular technology utilizes OCT to provide real-time intravascular imaging during the treatment of peripheral artery disease. The Company’s Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing catheters are the only catheters available worldwide that incorporate the additional benefits of real-time intravascular imaging during PAD treatment.

While the FDA has already cleared OCT diagnostic claims for Avinger’s Pantheris and Ocelot catheters, and reimbursement codes applicable to therapeutic peripheral interventions with the Company’s Lumivascular catheters already exist, the results of the SCAN study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS in this setting. The study will enroll up to 20 subjects diagnosed with peripheral artery disease at two centers in the United States, with the goal to acquire at least 115 matched images generated by OCT and IVUS imaging for analysis. More specifically, OCT and IVUS images will be captured at identical positions within vessel segments so that a comparison can be made between the two imaging modalities. Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals, will serve as physician investigators in this study. Dr. Suhail Dohad, an interventional cardiologist in Los Angeles, will also serve as an advisor to the study.

Dr. Edward Pavillard, who enrolled the first cases in the SCAN study, noted, “As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intravascular view of arterial structures and disease distribution leads to better results for my patients versus if I relied solely on fluoroscopy. Given the correlation between the use of intravascular imaging and clinical outcomes, I am excited to participate in a study that will help expand the incorporation of OCT into the treatment paradigm for peripheral interventions.”

Dr. Luke Sewall commented, “OCT and IVUS have been well accepted imaging modalities for the diagnosis and treatment of atherosclerotic disease. Published data have shown that intravascular imaging may allow a clinician to more accurately assess vessel size, plaque characteristics, anatomical features, and the adequacy of interventional results. OCT and IVUS imaging also have the potential to limit the amount of radiation to which physicians and cath lab staff are exposed, and also reduce the volume of contrast agent used in the intervention, which can be particularly important in successfully treating patients suffering from impaired kidney function.”

“This trial represents an important component of our growth strategy. If successful, the results from this study should help support our application for incremental diagnostic reimbursement in procedures incorporating our Lumivascular technology,” said Jeff Soinski, Avinger’s president and CEO. “With diagnostic reimbursement already in place for IVUS imaging in the peripheral arteries, we believe that the reimbursement structure should also support the use of OCT for these types of interventions, especially given the high quality of intravascular imaging provided by OCT.”

About Avinger, Inc.

Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the PantherisÒ family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

Contact Information

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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 results of the SCAN study, reimbursement changes, reductions in radiation and contrast media exposure, and increased use of OCT imaging. 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; our ability to demonstrate the benefits of our Lumivascular platform; the resource requirements related to Pantheris; the outcome of clinical trial results; potential exposure to third-party product liability, intellectual property and other litigation; lack of long-term data demonstrating the safety and efficacy of our Lumivascular platform products; experiences of high-volume users of our products may lead to better patient outcomes than those of physicians that are less proficient; 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” and elsewhere in our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2018. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.

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