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 reported results for the fourth quarter ended December 31, 2020.

Fourth Quarter and Recent Highlights

• Revenue increased 19% sequentially to $2.7 million, the highest level in 3 years
• Image-guided CTO revenue increased 38% sequentially, driven by limited launch of the new Tigereyeâ„¢ device
• Gross margin rose sequentially to 36%, reflecting increased sales activity and cost efficiency
• Opened 9 new Lumivascular accounts in the fourth quarter, bringing total new accounts for the full year to 36
• Progressed Tigereye to full commercial launch in January 2021, following successful limited launch in the fourth quarter
• Improved the terms of Avinger’s existing loan agreement in January 2021, including the extension of the maturity date to 2025
• Ended December 31, 2020 with cash on hand of $22.2 million and added approximately $13 million in net proceeds from a common stock offering in February 2021

Jeff Soinski, Avinger’s President and CEO, commented, “Avinger remains focused on driving top-line growth by introducing new products, launching new accounts and expanding utilization at existing sites. In January, we progressed to full commercial launch of Tigereye, our next generation CTO-crossing device, following completion of a successful limited launch program in the fourth quarter. Patient outcomes are compelling as more and more sites complete their first cases with this new device, demonstrating the benefits of Tigereye’s enhanced imaging, steerability and new distal tip design in a real-world clinical setting.”

“We enter 2021 in a strong competitive position with three next generation products launched over the past three years, a leaner operating cost structure, a more capable commercial organization and a strengthened balance sheet. We are also investing in future growth drivers, including our next generation Lightbox 3 slated for 510(k) submission by mid-year, additional new PAD catheter solutions, the expansion of our field sales team and advancement of our clinical efforts in support of expanded use and reimbursement. In addition, we are in the first stages of expanding into the coronary artery disease (CAD) market by developing proprietary new product applications of our Tigereye technology for the treatment of chronic total occlusions in this challenging and underserved market.”

Fourth Quarter 2020 Financial Results

Total revenue was $2.7 million for the fourth quarter of 2020, an increase of 19% from the third quarter of 2020, and an increase of 7% from the fourth quarter of 2019. The sequential increase in revenue reflected sales during the limited launch of Avinger’s Tigereye CTO crossing catheter and continued recovery from the effects of the COVID-19 pandemic.

Gross margin for the fourth quarter of 2020 was 36%, an increase of 200 basis points from 34% in the third quarter of 2020 and the highest gross margin level in the last 4 years. Operating expenses for the fourth quarter of 2020 were $5.2 million, compared with $4.9 million in the third quarter of 2020, due to expansion of the commercial team and launch of Tigereye. Fourth quarter operating expenses decreased 12% from $5.9 million in the fourth quarter of 2019.

Net loss and comprehensive loss for the fourth quarter of 2020 was $4.6 million, compared with $4.5 million in the third quarter of 2020 and $5.1 million in the fourth quarter of 2019.

Adjusted EBITDA, as defined under non-GAAP measures in this press release, was a loss of $3.7 million, compared with a loss of $3.5 million in the third quarter of 2020, and a loss of $4.1 million in the fourth quarter of 2019.

For more information regarding non-GAAP financial measures discussed in this press release, please see “Non-GAAP Financial Measures” below, as well as the reconciliation of GAAP to non-GAAP measures provided in the tables below.

Balance Sheet

Cash and cash equivalents totaled $22.2 million as of December 31, 2020, compared with $25.3 million as of September 30, 2020. Subsequent to December 31, 2020, Avinger raised approximately $13.0 million in net proceeds from a bought deal offering, providing a cash balance of over $35 million when added to the Company’s year-end cash position. Avinger amended the existing loan agreement in January 2021, including the extension of the interest only period and maturity date of the term loan by 2 ½ years. The interest only period is extended from June 30, 2021 to December 31, 2023. The maturity date is extended from June 30, 2023 to December 31, 2025. In addition, the amendment reset the material adverse change representation date and adjusted the minimum revenue requirements.

Conference Call

Avinger will hold a conference call today, March 11, 2021 at 4:30pm ET to discuss its fourth quarter 2020 financial results.

Individuals interested in listening to the conference call may do so by dialing +1-201-689-8031. To listen to a live webcast, please visit  http://www.avinger.com  and select Investor Relations. A webcast replay of the call will be available on Avinger’s website following completion of the call at  www.avinger.com.

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 Tigereyeâ„¢ 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.