Avinger Achieves Commercial Milestone with More Than 100 Accounts Using Pantheris SV

REDWOOD CITY, CA / ACCESSWIRE / April 15, 2021 / 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 Peripheral Artery Disease (PAD), today reported that more than 100 accounts have purchased Pantheris SV OCT-guided atherectomy catheters for the treatment of PAD since product launch in the third quarter of 2019.

"By combining real-time intravascular imaging with the precise control of directional atherectomy, our Pantheris SV device is proving to be an optimal choice for the treatment of peripheral artery disease in small vessels," commented Jeff Soinski, Avinger's President and CEO. "Due to the low profile and longer length of the device, physicians are able to safely and effectively target the more distal regions of the vasculature below-the-knee (BTK), increasing the number of addressable procedures for Avinger by as much as 50%. We sold more than 1,700 Pantheris SV catheters in 2020, growing revenue for the device by more than 100% compared to 2019, and 2021 is off to an exciting start."

Dr. Tom Davis, an interventional cardiologist and principal investigator in the IMAGE-BTK clinical study, stated, "I believe Pantheris SV represents a significant leap forward for the treatment of patients with below-the-knee disease or suffering from critical limb ischemia, the severest form of PAD. The onboard image-guidance allows me to precisely excise plaque while avoiding damage to the healthy vessel, which is generating successful acute results and durable longer-term clinical outcomes in my practice. We are excited to validate the early positive experiences seen with this technology in IMAGE-BTK, a post-market clinical study designed to evaluate the safety and efficacy of Pantheris SV in below-the-knee interventions."

Pantheris SV, a product line extension of Avinger's onboard image-guided atherectomy platform, expands Avinger's portfolio of atherectomy devices for the treatment of PAD and is expected to increase the number of addressable procedures for the Company's Lumivascular technology. Pantheris SV features a longer 140 cm catheter length and a smaller six French (6F) profile to allow physicians to target more distal regions of the vasculature in smaller diameter vessels, including those below-the-knee.

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray 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, due to real-time OCT images generated from inside the artery, 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 and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. 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 and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. 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 our future performance, patient benefits of our products, including Pantheris SV, and expected increases in addressable procedures for our Lumivascular technology. 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; the resource requirements related to Pantheris, TIGEREYE and our Lightbox imaging console; the outcome of clinical trial results; 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 11, 2021. 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:
Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
[email protected]

Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
[email protected]

SOURCE: Avinger, Inc.