Avinger, Inc.: Avinger Releases Updated Data From IMAGE-BTK in Webinar Featuring Key Opinion Leaders in the Field of Vascular Intervention

REDWOOD CITY, CA / ACCESSWIRE / October 24, 2024 / Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease hosted a physician-focused webinar entitled, "New Approaches to Treating Peripheral Artery Disease (PAD) Below-the-Knee (BTK) and Promising New BTK Data." A recording of the webinar may be accessed at https://pages.avinger.com/webinar-new-approaches-to-treating-btk-pad.

The webinar featured key opinion leaders in the field of vascular intervention from different specialties and geographies as follows:

• Dr. Michael Lichtenberg, an angiologist and the Chief Medical Officer and Director of the Angiology Department and Vascular Center at the Arnesberg Clinic in Arnesberg, Germany presented on the challenges of treating below-the-knee vascular disease and offered a future perspective on treating BTK and critical limb ischemia. Dr. Lichtenberg has over 20 years of experience in endovascular interventions and served as the Managing Director and President of the German Society for Angiology.

• Dr. Thomas Davis, an interventional cardiologist, Director of Cardiovascular Research at St. John Hospital and Medical Center in Detroit, Michigan and Avinger's Chief Medical Officer, provided an overview of the Pantheris SV device and reviewed updated data from the IMAGE-BTK study - a prospective, global, multi-center trial studying the treatment of BTK lesions with Pantheris SV. Pantheris SV, Avinger's proprietary technology for PAD interventions in small diameter peripheral vessels, features an intravascular image-guidance system combined with a targeted plaque excision mechanism for safe and durable outcomes. Dr. Davis has over three decades of clinical practice and leadership in cardiovascular medicine and has pioneered the use of cutting-edge interventional technologies to treat lower extremity arterial disease. He has served on several scientific advisory boards, on faculty at national conferences, as an investigator in multiple clinical trials, and has authored multiple publications.

• Dr. Philip Auyang, a board-certified vascular surgeon specializing in both vascular and endovascular surgery in Houston, Texas, shared a case study featuring the minimally invasive treatment of multi-level PAD with Pantheris in a patient with recurrence of a blockage within stents previously placed above-the-knee, and stenoses below-the-knee. He treats all forms of arterial and venous disorders and has authored several publications on the treatment of vascular disease in the Journal of Vascular Surgery and Annals of Vascular Surgery.

In his presentation, Dr. Davis presented updated interim data from IMAGE-BTK, a post-market study designed to evaluate the safety and efficacy of Pantheris SV in below-the-knee procedures, historically an extremely challenging subset of PAD interventions. The study enrolled 51 patients with 58 lesions treated, and now includes follow-up data collected on 45 patients at 6 months and 33 patients at 12 months. In terms of safety, the data showed 100% freedom from major adverse events at 30 days, 0% all-cause mortality at 30 days, and no major unplanned amputations. Follow-up of these patients at 12-months yielded 97% freedom from target lesion revascularization, a measure of restenosis, and 94% primary patency as assessed by duplex ultrasound.

Summarizing this exciting new data, Dr. Davis commented, "With over 30 patients now with 12-month follow-up, the promising safety and efficacy data from IMAGE-BTK has reached a point of statistical significance in terms of freedom from target lesion revascularization and primary patency, the gold standard for measuring efficacy of these types of interventions. Pantheris SV, with its onboard image-guidance and directional mechanism of action allows for significant luminal gain while preserving native vessel structures, and has provided unprecedented acute and long-term results for this patient population suffering from a very advanced stage of PAD. This data supports the building evidence that Pantheris SV should serve as a primary interventional platform to address these challenging BTK lesions."

Avinger's Lumivascular technology incorporates an onboard image-guidance system to allow physicians to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT. During the procedure, high-resolution intravascular OCT images are displayed on Avinger's Lightbox console in real-time to guide therapy. Physicians performing therapeutic procedures with other devices must rely solely on X-ray images and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions to deliver safe and effective outcomes, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first image-guided, catheter-based system for the diagnosis and treatment of patients with vascular disease in the peripheral and coronary arteries. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye® family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices for the treatment of peripheral artery disease (PAD), estimated to affect more than 200 million people worldwide. Avinger is developing its first product application for the treatment of coronary artery disease (CAD), an image-guided system for CTO-crossing in the coronary arteries, which provides the opportunity to redefine a large and underserved market. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.

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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 our IMAGE-BTK study, and anticipated patient and physician benefits of our products, including Pantheris SV. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of studies; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2024, as amended, and Quarterly Report on Form 10-Q. 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.

Investor Contact:
Matt Kreps
Darrow Associates Investor Relations
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Public Relations Contact:
Phil Preuss
Chief Commercial Officer
Avinger, Inc.
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SOURCE: Avinger, Inc.

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