Avinger

Avinger, Inc. is a commercial-stage medical device company, which engages in the designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral artery disease. Its products include Pantheris, Lightbox, Ocelot, Wildcat, Juicebox, and Kittycat. The company was founded by John B. Simpson and Himanshu N. Patel on March 8, 2007 and is headquartered in Redwood City, CA.

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Avinger reports Q1 revenue growth, secures China partnership for expansion

Avinger's Q1 2024 performance showed revenue growth but challenges in profitability.
Strategic partnerships and product development present growth opportunities.
Financial restructuring and cost management are crucial for future success.

Avinger reports improved Q3 performance and strategic growth initiatives

Avinger's Q3 2024 performance showed operational improvements and cost-saving initiatives, leading to reduced losses.
The company's strategic partnerships and focus on innovation position them for growth opportunities in the medical device market.
While challenges persist, Avinger's progress in commercialization and partnerships signal a path towards financial stability.

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REDWOOD CITY, CA / ACCESSWIRE / April 19, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced full commercial availability of its new Lightbox 3 imaging console designed to enhance the user experience and drive faster adoption at new hospital sites. Avinger received 510(k) clearance for the Lightbox 3 from the U.S. Food & Drug Administration (FDA) in January, and conducted a successful limited launch with key opinion leaders in February and March.

Avinger Announces Full Commercial Launch of Lightbox 3

16 New U.S. and International Patents Issued over Past Year REDWOOD CITY, CA / ACCESSWIRE / March 30, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced the issuance of three new U.S. patents in March 2022 and provided an update on the expansion of its intellectual property portfolio. The following three new U.S. patents expanding intellectual property protection for Avinger's proprietary imaging platform and image-guided therapeutic devices were issued in March 2022: U.S. patent 11,284,839, Optical Coherence Tomography for Biological Imaging, broadens coverage for Avinger's proprietary OCT imaging platform.

Avinger Announces Issuance of Three New U.S. Patents in March 2022

REDWOOD CITY, CA / ACCESSWIRE / March 29, 2022 / 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 it has regained compliance with Nasdaq listing requirements. In a letter dated March 29, 2022, Nasdaq informed the Company that it has achieved compliance with the minimum bid price rule required for continued listing on the Nasdaq Capital Market.

Avinger Regains Compliance with Nasdaq Listing Requirements

Avinger (AVGR) delivered earnings and revenue surprises of 0% and 4.48%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

Avinger (AVGR) Reports Q4 Loss, Tops Revenue Estimates

Avinger, Inc.'s (AVGR) CEO Jeff Soinski on Q4 2021 Results - Earnings Call Transcript

Avinger Inc (NASDAQ: AVGR) reported a fourth-quarter revenue decrease of 12% year-over-year to $2.40 million, beating the consensus of $2.29 million. Hospital constraints impacted Q4 on procedural volume and hospital staffing shortages related to the resurgence of COVID-1.

Avinger Registers 12% Decline In Q4 Revenue, Says Hospital Constraints Impacted Q4

REDWOOD CITY, CA / ACCESSWIRE / March 22, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today reported results for the fourth quarter and full year ended December 31, 2021. Financial and Recent Highlights Full year 2021 revenue of $10.1 million, an increase of 16% from the prior year Fourth quarter revenue of $2.4 million, reflecting the impact of Omicron variant surge and hospital staffing shortages on procedural volume Full year gross margin of 34%, increased from 30% in 2020 Ground-breaking clinical data from INSIGHT trial, evaluating the safety and efficacy of Pantheris for the treatment of in-stent restenosis (ISR), presented at the VIVA clinical conference in October 2021 Received 510(k) clearance in November 2021 for a new ISR clinical indication for Pantheris, the only directional atherectomy device to have this indication Received 510(k) clearance in January 2022 for the Lightbox 3 next-generation imaging console Successfully completed first cases with Lightbox 3 in select hospitals beginning in February 2022, paving the way for expansion to full commercial availability in the second quarter of 2022 Progressed the development of two new catheter line extensions for PAD treatment Advanced initial development efforts for the first ever image-guided CTO-crossing catheter for the treatment of coronary artery disease (CAD) Maintained a strong cash position of $19.5 million at December 31, 2021, enhanced by the addition of $7.6 million in gross proceeds raised in January 2022 "The Avinger team executed important strategic initiatives across the company during 2021, despite the continued challenges of the COVID-19 resurgence," commented Jeff Soinski, Avinger's President and CEO.

Avinger Reports Fourth Quarter and Year End 2021 Results

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REDWOOD CITY, CA / ACCESSWIRE / March 15, 2022 / Avinger, Inc. (NASDAQ:AVGR), 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 that it will release its financial results for the fourth quarter and full year 2021 after the close of trading on Tuesday, March 22, 2021. The Company will host a conference call beginning at 1:30 pm PT/4:30 pm ET.

Avinger to Announce Full-Year 2021 Results on March 22

REDWOOD CITY, CA / ACCESSWIRE / March 14, 2022 / 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 that the Company will effect a 1-for-20 reverse stock split of the Company's common stock, which will be effective at 5:00 p.m. Eastern time on Monday, March 14, 2022.

Avinger to Effect One-for-Twenty Reverse Stock Split

Patients Treated in Four Additional Hospitals Using New Portable System REDWOOD CITY, CA / ACCESSWIRE / March 7, 2022 / 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 the expansion of first case experience with its new Lightbox 3 imaging console to four additional hospitals in Pennsylvania and New Jersey. Patients were treated at the four sites over three days using a single Lightbox 3 in a portable system configuration designed for easy transport and set-up by Avinger's clinical sales team.

Avinger Expands Lightbox 3 First Case Experience

The Avinger Inc (NASDAQ: AVGR) stock increased by over 20% during intraday trading today. This is why.

Avinger (AVGR) Stock: Why It Jumped Up Today

REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / 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 that physicians in the U.S. have successfully completed first cases with its new Lightbox 3 imaging console. The Lightbox 3 received 510(k) pre-marketing clearance from the U.S. Food & Drug Administration (FDA) in January.

Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

REDWOOD CITY, CA / ACCESSWIRE / January 14, 2022 / Avinger, Inc. (NASDAQ:AVGR) (the "Company"), 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 the closing of its previously announced registered direct offering of an aggregate of 7,600 shares of Series D convertible preferred stock (the "Preferred Stock") and warrants to purchase up to an aggregate of 16,150,000 shares of common stock to certain institutional investors for gross proceeds of $7.6 million. The shares of Preferred Stock have a stated value of $1,000 per share and are convertible into an aggregate of 19,000,000 shares of common stock at a conversion price of $0.40 per share.

Avinger Announces Closing of $7.6 Million Registered Direct Offering

REDWOOD CITY, CA / ACCESSWIRE / January 12, 2022 / Avinger, Inc. (NASDAQ:AVGR) (the "Company"), 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 that it has entered into a definitive agreement with certain institutional investors for the issuance and sale in a registered direct offering of an aggregate of 7,600 shares of Series D convertible preferred stock (the "Preferred Stock") and warrants to purchase up to an aggregate of 16,150,000 shares of common stock for gross proceeds of $7.6 million. The shares of Preferred Stock will have a stated value of $1,000 per share and are convertible into an aggregate of 19,000,000 shares of common stock at a conversion price of $0.40 per share.

Avinger Announces $7.6 Million Registered Direct Offering

REDWOOD CITY, CA / ACCESSWIRE / January 11, 2022 / 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 that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Lightbox 3 imaging console. "We are excited to receive U.S. pre-marketing clearance for the Lightbox 3 imaging console.

Avinger Announces 510(k) Clearance for Lightbox 3 Next-Generation Imaging Console

Avinger Inc (NASDAQ:AVGR) received 510(k) clearance from the FDA for a new clinical indication for the Pantheris image-guided atherectomy system. The clearance allows the Company to directly market Pantheris for in-stent restenosis (ISR) in the lower extremity arteries.

Avinger Stock Surges As Pantheris Scores FDA Approval For In-Stent Restenosis Indication

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New indication expands addressable market for Pantheris REDWOOD CITY, CA / ACCESSWIRE / November 17, 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 that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for a new clinical indication for the Pantheris image-guided atherectomy system. This clearance allows the company to directly market Pantheris for the treatment of in-stent restenosis (ISR) in the lower extremity arteries.

Avinger Announces FDA Clearance of Pantheris for the Treatment of In-Stent Restenosis

Avinger, Inc.'s (AVGR) CEO Jeff Soinski on Q3 2021 Earnings Conference Call - Earnings Call Transcript

REDWOOD CITY, CA / ACCESSWIRE / November 11, 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 reported results for the third quarter ended September 30, 2021. Third Quarter and Recent Highlights Revenue of $2.4 million, an increase of 3% from the prior year quarter Gross margin of 34%, consistent with the prior year quarter Opened 8 new Lumivascular accounts, despite the negative impact of COVID-19 resurgence in the third quarter Announced 510(k) submission in July to expand Pantheris' clinical indication to include treatment of in-stent restenosis (ISR), a large and underserved market Filed 510(k) submission in August for the Lightbox 3 next generation imaging console to accelerate adoption through a feature rich, lower cost solution enabling more flexible installation options Made significant advancements in the development of two new catheter line extensions for PAD treatments expected to be filed for 510(k) clearance in the first half of 2022 Progressed initial development efforts for first ever image-guided CTO-crossing catheter for treatment of the coronary arteries Maintained a strong cash position of $23.1 million at September 30, 2021, anticipated to fund new product development and clinical plans through 2022 Jeff Soinski, Avinger's President and CEO, commented, "We continued progress on our key strategic and market growth initiatives in the third quarter, including filing a 510(k) application for our new Lightbox 3 imaging console, advancing the development of our new catheter programs, and expanding our platform to eight new clinical sites.

Avinger Reports Third Quarter 2021 Financial Results

Avinger (AVGR) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Avinger (AVGR) May Report Negative Earnings: Know the Trend Ahead of Next Week's Release

REDWOOD CITY, CA / ACCESSWIRE / October 29, 2021 / Avinger, Inc. (NASDAQ:AVGR), 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 that it will release its financial results for the third quarter 2021 after the close of trading on Thursday, November 11, 2021. The Company will host a conference call beginning at 1:30 pm PT/4:30 pm ET.

Avinger to Announce Third Quarter Results on November 11, 2021

Study Outcomes Demonstrate Safety and Efficacy of Pantheris for Treatment of In-Stent Restenosis REDWOOD CITY, CA / ACCESSWIRE / October 7, 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 that clinical data from the INSIGHT study were presented during the Late-Breaking Clinical Trials session at the VIVA (Vascular InterVentional Advances) conference in Las Vegas. The INSIGHT trial was designed to evaluate the safety and effectiveness of Avinger's Pantheris image-guided atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries.

Ground-Breaking Clinical Data from INSIGHT Trial Presented at VIVA

REDWOOD CITY, CA / ACCESSWIRE / September 8, 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 that its management will participate in investor meetings September 13-15, 2021 as part of the H.C. Wainwright 23rd Annual Global Investment Conference.

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