Avinger Announces Full Commercial Launch of Lightbox 3

Rhea-AI Summary

Avinger, Inc. (NASDAQ:AVGR) announced the full commercial availability of its Lightbox 3 imaging console, designed to enhance vascular disease treatment. Following FDA's 510(k) clearance in January, the product has been used at 12 clinical sites with positive physician feedback. The Lightbox 3 offers high-definition imaging, reducing reliance on contrast dye and improving operational efficiency. Its portability aims to accelerate new user adoption, contributing to increased productivity for Avinger's field teams and promoting device utilization.

Positive

• Full commercial launch of Lightbox 3 enhances physician experience and potential revenue.
• High-definition imaging improves treatment efficacy and reduces reliance on contrast dye.
• Lightbox 3's portability increases productivity and accelerates new user site adoption.

Negative

• None.

REDWOOD CITY, CA / ACCESSWIRE / April 19, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced full commercial availability of its new Lightbox 3 imaging console designed to enhance the user experience and drive faster adoption at new hospital sites.

Avinger received 510(k) clearance for the Lightbox 3 from the U.S. Food & Drug Administration (FDA) in January, and conducted a successful limited launch with key opinion leaders in February and March. Physicians have now utilized the new Lightbox 3 with Avinger's Tigereye CTO-crossing and Pantheris atherectomy catheters at 12 clinical sites throughout the U.S. Commercial experience during the limited launch phase also validated a new mobile strategy option, whereby a single, highly portable Lightbox 3 can be efficiently deployed across multiple hospital sites. This new mobile strategy is intended to increase the productivity of Avinger's field teams, accelerate the launch of new user sites, and reduce sales cycle time, combining to augment utilization of Avinger's disposable interventional devices.

Jeff Soinski, Avinger's President and CEO commented, "Physician feedback for our next-generation Lightbox 3 imaging console has been very positive, and we are excited to progress to full commercial availability. Users noted that the enhanced high-definition imaging facilitated the identification of disease morphology and arterial wall structures during treatment, and the new user interface allowed for more efficient operation. We believe the significant clinical benefits of our proprietary intravascular image-guided system, combined with the portability and reduced cost of the Lightbox 3, will energize existing users and accelerate new account acquisition as we progress throughout the 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 catheterization 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.

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; the benefits of Lightbox 3, including improved productivity of field teams, the timing of launching new user sites, sales cycle timing, and new account acquisitions; the benefits of Lightbox 3 to physicians; our product development efforts; and the potential applications of our intellectual property. 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 the resource requirements related to Lightbox 3 and the development of our first coronary applications, the efficacy of such products, and competition from other products; 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 22, 2022, 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, except as required by law.

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.

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FAQ

What is Avinger, Inc.'s latest announcement regarding the Lightbox 3?

Avinger announced the full commercial availability of its Lightbox 3 imaging console, which enhances treatment for vascular disease.

What are the benefits of the Lightbox 3 imaging console?

Lightbox 3 provides high-definition imaging, reduces reliance on contrast dye, and features an intuitive user interface for better efficiency.

How does Lightbox 3 impact Avinger's business performance?

The portability and enhanced features of Lightbox 3 are expected to drive faster adoption at new hospital sites, increasing sales potential.

When did Avinger receive FDA clearance for Lightbox 3?

Avinger received 510(k) clearance from the FDA for Lightbox 3 in January 2022.

At how many clinical sites has Lightbox 3 been used?

Lightbox 3 has been utilized at 12 clinical sites throughout the U.S.