Avinger (AVGR) Granted 510(k) Clearance for Lightbox 3 Next-Generation Imaging Console

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 announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console.

"We are excited to receive U.S. pre-marketing clearance for the Lightbox 3 imaging console. Our new Lightbox 3 delivers important advancements in imaging, portability and capability," commented Jeff Soinski, Avinger's President and CEO. "The Lightbox 3 is designed to accelerate new account acquisition, energize existing users and support new catheter capabilities in the future. We believe the reduced cost and increased portability of this significantly smaller console will be a major factor in efficiently expanding our Lumivascular treatment to new high-volume PAD centers and streamline the adoption of our technology."

Dr. Jaafer Golzar, Avinger's Chief Medical Officer, remarked, "Avinger has made significant advances in developing its proprietary portfolio of image-guided catheters with the introduction of three new catheter platforms in the last three years. The new Lightbox 3 represents the next leap forward with the release of an advanced imaging console designed to improve the user experience and support increased utilization of Avinger's image-guided devices. I am confident that the high-definition imaging and simplified user interface provided by the Lightbox 3 will facilitate positive patient outcomes in the hands of both new and experienced physicians."

Lightbox 3 incorporates advanced features, including an advanced solid-state laser for enhanced high-definition OCT imaging, a more powerful computing platform, and a redesigned software system with a highly intuitive user interface that emphasizes efficiency and ease-of-use. The Lightbox 3 presents a significant reduction in size, weight and cost compared to the existing platform, and is anticipated to accelerate the evaluation process and reduce barriers to developing new accounts. The Lightbox 3 fits into a case the size of a carry-on suitcase and weighs less than 20 pounds. This 90% reduction in size and weight over the prior generation Lightbox console provides for easy transport, efficient installation options, and a simplified service strategy.

The Company intends to initiate a limited launch of Lightbox 3 in the United States early in the first quarter of 2022 and subsequently expand to full commercial availability.

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.

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