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May 30, 2015 7:08 PM 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
Compensation as of Fiscal Year 2014.

Avinger, Inc. Key Developments

Avinger, Inc. Announces 30-Day Interim Results for its Vision Clinical Study

Avinger, Inc. announced 30-day interim results for its VISION clinical study. VISION is designed to evaluate the safety and efficacy of the Pantheris system to perform directional atherectomy, while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Results were presented at the EuroPCR 2015 medical conference. VISION interim results demonstrated that Pantheris treatment residual stenosis of less than or equal to 50% was achieved in 96% of lesions, surpassing the primary efficacy endpoint performance goal. Both blood flow measurement (Ankle Brachial Index) and symptom-based (Rutherford Classification) outcomes measures showed statistically significant improvement across all patients undergoing 30-day follow-up. Safety data at the time of procedure and through 30 days also indicated an extremely favorable acute safety profile, with zero dissections and zero perforations related to the use of the Pantheris catheter as adjudicated by an independent Clinical Events Committee (CEC). The study's primary safety endpoint is defined as freedom from a composite of major adverse events (MAEs) in less than or equal to 43% of patients through six-month follow-up. While not representative of six-month results, 7% of patients in the VISION trial had experienced an MAE through 30 days. In addition to positive clinical outcomes, VISION study histology results highlighted the tremendous precision that real-time optical coherence tomography (OCT) guidance enables during atherectomy. Across all lesions treated and analyzed for histology, the average percent area of adventitia in the atherectomy tissue samples collected was 1.0%. Histology results are expected to be a key differentiator in the VISION trial, and data correlations are anticipated to further support the hypothesis that improved atherectomy accuracy will result in less arterial wall disruption, ultimately helping to minimize restenosis and need for retreatment. Avinger completed patient enrollment in the VISION clinical trial in March 2015. Data collection and analysis is ongoing for the six-month follow-up period defined in the study. The Company expects to present six-month data in the fourth quarter of 2015. Following availability of six-month data, primary endpoint analysis results will be used to support a 510(k) application with the FDA.

Avinger, Inc. Reports Unaudited Earnings Results for the First Quarter Ended March 31, 2015; Provides Earnings Guidance for the Full Year of 2015

Avinger, Inc. reported unaudited earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported revenues of $2.088 million compared to $2.119 million a year ago. Loss from operations of $9.425 million compared to $6.379 million a year ago. Loss before provision for income taxes of $10.416 million compared to $7.950 million a year ago. Net loss and comprehensive loss attributable to common stockholders was $12.801 million or $1.53 per basic and diluted share compared to $7.971 million or $32.94 per basic and diluted share a year ago. Adjusted EBITDA was $7.876 million compared to $5.785 million a year ago. As stated on March 12, 2015, the company projects total revenue for 2015 to be in the range of $12 million to $14 million, which represents year-over-year growth ranging from 7% to 25%. Adjusted EBITDA for 2015 is projected 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. to Report Q1, 2015 Results on May 06, 2015

Avinger, Inc. announced that they will report Q1, 2015 results After-Market on May 06, 2015

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