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.”
Lightbox 3 incorporates an advanced solid-state laser for high-definition intravascular OCT imaging, improving visualization while reducing the need for contrast dye, which can be contraindicated for many PAD patients. With a more powerful computing platform and redesigned software system, the highly intuitive user interface emphasizes efficiency and ease-of-use in the cath lab setting. The Lightbox 3 also brings a significant reduction in size, weight and cost compared to the predecessor console, which is anticipated to accelerate the evaluation process and reduce barriers to developing new accounts. The Lightbox 3 fits into a carry-on sized case and weighs less than 20 pounds – a 90% reduction in size and weight that provides for easy transport, efficient installation, and a simplified service strategy.
Avinger’s proprietary Lumivascular technology allows physicians, for the first time ever, to see 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 the potential benefits of Lightbox 3 for patients and healthcare providers, the impact of Lightbox 3 on workflows during clinical procedures, our ability to generate new account acquisitions, the impact of Lightbox 3 on the adoption of our image-guided devices and other technology, the impact of Lightbox 3 on the development and adoption of new catheter capabilities, the timing and scope of the commercial launch of Lightbox 3, and the impact of Lightbox 3 on our business. 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; the adoption of our products by healthcare providers; 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 and in our Quarterly Reports 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:
Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
ir@avinger.com
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
mkreps@darrowir.com
SOURCE: Avinger, Inc.
