Avinger Initiates Full Commercial Launch of Tigereye(TM) Image-Guided CTO Crossing Catheter

Rhea-AI Summary

Avinger, Inc. (NASDAQ:AVGR) announced the full commercial launch of its Tigereye™ image-guided chronic total occlusion (CTO) crossing system on January 15, 2021. Following a limited launch in Q4 2020, where approximately 50 successful CTO cases were performed at 12 clinical sites in the U.S. and Germany, the Tigereye device is now available for order in these markets. The device features high-definition intravascular imaging and capabilities designed to enhance treatment efficiency for complex PAD cases. Avinger aims for increased revenue growth opportunities in 2021 through its advanced product offerings.

Positive

• Successful limited launch demonstrated strong clinical capabilities with 50 CTO cases performed.
• Tigereye offers advanced imaging and control features, enhancing treatment for complex PAD.
• Expected increase in revenue growth opportunities in 2021 with full commercial launch.

Negative

• None.

REDWOOD CITY, CA / ACCESSWIRE / January 15, 2021 / 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 full commercial launch of its Tigereye™ image-guided chronic total occlusion (CTO) crossing system. With the initiation of full commercial launch, current and prospective accounts throughout the US and Germany are now able to order the Tigereye device.

During the fourth quarter of 2020, Avinger conducted a limited launch at 12 clinical centers in the U.S. and Germany. Approximately 50 CTO cases were successfully performed, showcasing Tigereye's advanced clinical capabilities and excellent product reliability in a variety of lesion types and settings.

"The limited launch program demonstrated Tigereye's strong clinical results and efficiency across a wide range of PAD cases," commented Dr. Jaafer Golzar, an interventional cardiologist and Avinger's Chief Medical Officer. "The enhanced imaging, higher rotational speeds and ability to precisely control the device inside the vessel are truly remarkable advancements in Avinger's family of intravascular OCT-guided catheters. Physicians have been able to consistently, safely and effectively cross complex CTOs, including cases that may have required more invasive procedures such as bypass or amputation, fully demonstrating the unique benefits of Avinger's proprietary image-guided technology."

Jeff Soinski, Avinger's President and CEO, said, "We are excited to progress to full commercial launch of our next-generation Tigereye device. The limited launch program conducted with 14 physician users affirmed our belief that Tigereye represents an important advance for physicians seeking better solutions on behalf of their CTO patients, who often present with the most challenging and complex PAD cases.

"We believe full commercial availability of the Tigereye device will be an important contributor to expanding our revenue growth opportunities in 2021, both in terms of attracting new Avinger user sites and supporting higher utilization per site," Soinski continued. "With three new product families launched in less than three years, Avinger offers physicians a comprehensive suite of the most advanced PAD therapeutic devices available today to provide effective, measurable treatment options with superior patient outcomes."

Tigereye features high definition, real-time intravascular imaging and a user-controlled deflectable tip designed for steerability within the lumen. Tigereye also includes an enhanced distal tip configuration with rotational speeds up to 1000 RPM designed to penetrate challenging lesions. The Tigereye catheter has a working length of 140 cm and 5 French sheath compatibility to enable treatment of lesions in peripheral vessels both above and below the knee. Tigereye is complementary to Avinger's image-guided atherectomy line of catheters, including the Pantheris Next Generation and Pantheris SV devices.

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, thanks to the 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 potential benefits of Tigereye™, the potential of Tigereye to be a significant growth driver for our CTO-crossing business, the benefits of Tigereye in the treatment of CTOs, our revenue growth in 2021, and our ability to attract new user sites and expand utilization at existing sites. 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 Tigereye 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 6, 2020, 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

Public Relations Contact:
Phil Preuss
Chief Marketing Officer
Avinger, Inc.
(650) 241-7056
pr@avinger.com

SOURCE: Avinger, Inc.

View source version on accesswire.com:
https://www.accesswire.com/624419/Avinger-Initiates-Full-Commercial-Launch-of-TigereyeTM-Image-Guided-CTO-Crossing-Catheter

FAQ

What is the Tigereye device launched by Avinger?

The Tigereye device is an image-guided chronic total occlusion (CTO) crossing system designed for treating Peripheral Artery Disease (PAD).

When did Avinger announce the full commercial launch of Tigereye?

Avinger announced the full commercial launch of Tigereye on January 15, 2021.

How many successful cases were performed during the limited launch of Tigereye?

Approximately 50 successful CTO cases were performed during the limited launch of Tigereye.

In which countries is the Tigereye device available for order?

The Tigereye device is available for order in the U.S. and Germany.

What are the expected benefits of the Tigereye device for PAD treatment?

Tigereye is expected to enhance treatment efficiency for complex PAD cases, offering advanced imaging and control capabilities.