October 20, 2017 9:47 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. It develops lumivascular platform that integrates optical coherence tomography visualization with interventional catheters to provide real-time intravascular imaging during the treatment portion of PAD procedures. The company’s lumivascular products comprise Lightbox imaging consoles, as well as the Ocelot family of catheters, which are designed to penetrate a total blockage in an artery; and Pantheris, an image-guided atherectomy device that allows physic...

400 Chesapeake Drive

Redwood City, CA 94063

United States

Founded in 2007

197 Employees

Phone:

650-241-7900

Key Executives for Avinger, Inc.

Chief Executive Officer, President and Director
Age: 55
Total Annual Compensation: $390.0K
Founder and Executive Chairman
Age: 73
Total Annual Compensation: $390.0K
Chief Financial Officer and Chief Business Officer
Age: 49
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2016.

Avinger, Inc. Key Developments

Avinger, Inc. Announces First Patient Enrolled in it's IDE Study of the Pantheris Image-Guided Atherectomy System for Treatment of In-Stent Restenosis

Avinger, Inc. announced initiation of INSIGHT, a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris® Lumivascular Atherectomy System for treating in-stent restenosis (ISR) in lower extremity arteries. Up to 140 patients will be enrolled in the INSIGHT trial at up to 20 U.S. and international centers. Sean Janzer, M.D. of Einstein Medical Center and Glen Schwartzberg, M.D. of Baton Rouge General Medical Center serve as co-principal investigators of the study. In-stent restenosis occurs when a blocked artery previously treated with a stent becomes narrowed again, reducing blood flow. Physicians often face challenges when treating in-stent restenosis both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques, such X-ray fluoroscopy, and the inability to control the directionality of other treatment modalities’ mechanism of action creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis, such as balloon angioplasty, have high rates of recurrent renarrowing within stents. Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach using real-time OCT image guidance, physicians can more accurately navigate their devices to treat PAD without exposing healthcare workers and patients to the negative effects of ionizing radiation.

Avinger, Inc. Announces Auditors Changes

On October 11, 2017, Avinger, Inc. dismissed Ernst & Young LLP as its independent registered public accounting firm. The audit committee of the Board of Directors recommended such dismissal and the Board approved such dismissal, effective as of October 11, 2017. On October 11, 2017, the audit committee of the Board approved the appointment of Moss Adams LLP as the company's new independent registered public accounting firm, effective October 11, 2017.

Rosen Law Firm Announces Filing of Securities Class Action Lawsuit Against Avinger, Inc

Rosen Law Firm announced the filing of a class action lawsuit on behalf of purchasers of the common stock of Avinger, Inc. pursuant and/or traceable to Avinger’s initial public offering on or about January 30, 2015, inclusive (the “Class Period”). The lawsuit seeks to recover damages for Avinger investors under the federal securities laws. According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Avinger did not have adequate sales and marketing personnel to increase sales of its lumivascular platform products and to commercialize Pantheris; (2) Avinger already experienced problems with the robustness of its lumivascular platform devices, including Pantheris; (3) physicians and hospitals were requiring more extensive and comprehensive training and education on the benefits of Avinger's products to convince them to adopt and implement its lumivascular platform products compared to competing products and procedures available in the market; (4) Avinger would not be able to achieve a rapid ramp rate for increased sales of its lumivascular platform; and (5) consequently, Avinger was experiencing lower sales and revenues. When the true details entered the market, the lawsuit claims that investors suffered damages.

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