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April 18, 2015 4:53 AM ET

Healthcare Equipment and Supplies

Company Overview of Avinger, Inc.

Company Overview

Avinger, Inc., a commercial-stage medical device company, designs, manufactures, and sells image-guided and catheter-based systems used by physicians to treat patients with peripheral arterial disease (PAD) in the United States and Europe. The company develops lumivascular platform, which integrates optical coherence tomography visualization with interventional catheters to provide real-time intravascular imaging during the treatment portion of PAD procedures. Its lumivascular products include the Lightbox imaging console and Ocelot family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions (CTOs). The company is also developing Pantheris...

400 Chesapeake Drive

Redwood City, CA 94063

United States

Founded in 2007

116 Employees

Phone:

650-241-7900

Fax:

800-229-2696

Key Executives for Avinger, Inc.

Chief Executive Officer, President and Director
Age: 52
Total Annual Compensation: $4.3K
Founder, Executive Chairman and Member of Audit Committee
Age: 70
Total Annual Compensation: $362.9K
Chief Financial Officer and Chief Business Officer
Age: 46
Total Annual Compensation: $300.9K
Senior Vice President of Operations and Quality
Age: 47
Total Annual Compensation: $301.3K
Vice President of Sales
Age: 35
Total Annual Compensation: $362.9K
Compensation as of Fiscal Year 2014.

Avinger, Inc. Key Developments

Avinger, Inc. Announces Executive Appointments, Effective April 20, 2015

Avinger, Inc. announced that John Borrell has been named as Vice President of Sales, effective April 20, 2015. Mr. Borrell will report directly to company's CEO, Jeff Soinski. Mr. Borrell joins the company with more than 25 years of medical technology sales and marketing experience, primarily with peripheral vascular and coronary products and procedures. Most recently, he served as Vice President of Sales and Global Marketing for TriReme Medical, where he led all U.S. sales operations and global marketing initiatives for peripheral and coronary interventional products. Mr. Borrell's background in the launch, commercialization and growth of medical devices for the treatment of PAD includes executive leadership roles at Cardiovascular Systems, Inc., where he served as Vice President of Sales and Marketing, and FoxHollow Technologies, where he was U.S. Director of Sales. John D. (JD) Simpson, company's current VP of Sales, will assume the position of Vice President of Business Development concurrent with Borrell joining the company. In this new role, Mr. Simpson will be responsible for developing and leading business development initiatives and strategic relationships to advance the company's overall corporate strategy and commercial objectives.

Avinger, Inc. Reports Earnings Results for the Fourth Quarter and Year Ended December 31, 2014; Provides Earnings Guidance for the Year 2015

Avinger, Inc. reported earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company reported total revenue of $3.1 million for the fourth quarter ended December 31, 2014, a decrease of 9% from $3.4 million in the comparable 2013 period. Fourth quarter 2014 revenues from the company's disposable devices were $1.5 million, while revenues associated with the company's Lightbox imaging console were $1.6 million. Loss from operations was $7.0 million, compared to $7.4 million for the fourth quarter of 2013. Adjusted EBITDA, a non-GAAP measure, was a loss of $6.5 million for the fourth quarter of 2014, compared to a $6.9 million loss for the fourth quarter of 2013. For the year, the company reported total revenue of $11.2 million compared to $13.0 million in 2013. The decrease in total revenue in 2014 was related to strategic decisions made by the company in the fourth quarter of 2013 to focus commercial efforts on its lumivascular programs to broaden physician exposure to optical coherence tomography (OCT) image interpretation, build the installed base of the Lightbox imaging console, and reduce cash consumption prior to Pantheris availability. Loss from operations was $25.0 million, compared to $37.0 million for 2013. Adjusted EBITDA, a non-GAAP measure, was a loss of $22.9 million for 2014 as compared to a loss of $34.8 million for 2013. The company expects 2015 revenue to be in the range of $12 million to $14 million, which represents year-over-year growth ranging from 7% to 25%. Adjusted EBITDA is expected to be a loss of $31 million to $33 million, representing an increase of 35% to 44% over 2014, as the company invests in the development of its lumivascular platform and expansion of its commercial infrastructure.

Avinger, Inc. Completes Patient Enrollment for VISION Clinical Trial

Avinger, Inc. announced that it has completed enrollment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the Company's Pantheris™ system. The Pantheris catheter is the only device to combine directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. In July 2014, the U.S. Food & Drug Administration (FDA) granted Avinger an investigational device exemption, or IDE, for Pantheris and the Company commenced enrollment of a 133-patient trial in the U.S. and Europe. The Company expects to present interim 30-day data in the second quarter and six-month data in the fourth quarter of 2015. Primary safety and efficacy endpoint analysis results will be used to support a 510(k) application with the FDA, anticipated to be filed in the second half of 2015.

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