Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

Excerpt from the Press Release:

REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / 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 physicians in the U.S. have successfully completed first cases with its new Lightbox 3 imaging console. The Lightbox 3 received 510(k) pre-marketing clearance from the U.S. Food & Drug Administration (FDA) in January. Avinger is expanding availability of the Lightbox 3 to additional sites on a limited basis and anticipates progressing to full commercial availability early in the second quarter of 2022.

Over the past week, Dr. Jaafer Golzar, an interventional cardiologist and Avinger’s Chief Medical Officer, and Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital, used the Lightbox 3 to complete a total of 15 image-guided CTO-crossing and atherectomy procedures with Avinger’s Tigereye and Pantheris catheters. Both physicians treated a variety of lesion types above and below the knee, including in-stent restenosis occlusions, with positive acute clinical outcomes achieved in all patients treated.

Commenting on his initial experience with the Lightbox 3 console, Dr. Ian Cawich noted, “My initial experience with the new Lightbox 3 was extremely positive. The significant enhancement in high-definition imaging made disease morphology and arterial wall structures clearly stand out during treatment. The new user interface was intuitive and easy to use. The small size of the console along with the ability to easily connect to our existing image bank allowed for efficient integration into our cath lab. I believe these improvements will allow us to streamline workflows during clinical procedures and, most importantly, provide the high quality, real-time information we need to provide the best care for our patients.”

Dr. Jaafer Golzar remarked, “The performance of the Lightbox 3 in these first clinical cases exceeded my high expectations. The enhanced imaging, improved user interface and small footprint of the Lightbox 3 represent a major leap forward for our platform, which I believe will allow more physicians to realize the benefits of our Lumivascular technology for the treatment of their PAD patients. In addition, the Lightbox 3 will allow for the development of new catheter capabilities in the future, which we believe will be beneficial to our coronary and peripheral development programs.”

“I was thrilled to attend many of these first cases and to see firsthand physician and cath lab staff excitement about the high-resolution imaging and overall enhanced clinical experience provided by the new Lightbox 3,” commented Jeff Soinski, Avinger’s President and CEO. “We believe these clinical benefits, plus the reduced cost and portability of Lightbox 3, will energize existing users and accelerate new account acquisition for our proprietary intravascular image-guided system. We look forward to gaining continued case experience with this advanced imaging console in the coming weeks and are excited about our planned expansion to full commercial availability early in the second quarter of this year.”

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