- The Avinger Inc (NASDAQ: AVGR) stock increased by over 20% during intraday trading today. This is why.
The 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) – stock increased by over 20% during intraday trading today. Investors are responding positively to Avinger announcing that physicians in the U.S. have successfully completed the 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 the 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. And 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.
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. And 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. And 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.
“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. Ian Cawich
“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.”
— Dr. Jaafer Golzar
“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. 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.”
— Jeff Soinski, Avinger’s President and CEO
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.