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 26, 2023 / 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 vascular disease, today announced the company has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for Tigereye® ST, its next-generation image-guided chronic total occlusion (CTO) crossing system. Tigereye ST expands and advances Avinger's proprietary image-guided CTO product line with compelling new features and benefits.

Avinger Receives 510(k) Clearance for Tigereye ST Image-Guided CTO Crossing System

Avinger, Inc (NASDAQ:AVGR ) Q4 2022 Earnings Call March 15, 2023 4:30 PM ET Company Participants Matt Kreps - Darrow Associates Investor Relations Jeff Soinski - President, CEO & Director Nabeel Subainati - VP, Controller, Principal Financial Officer & Accounting Officer Conference Call Participants Ramakanth Swayampakula - HC Wainwright Operator Good afternoon, ladies and gentlemen, and welcome to the Avinger Fourth Quarter and Full Year 2022 Results Call. At this time, all participants have been placed on a listen-only mode and the floor will be open for questions and comments after the presentation.

Avinger, Inc (AVGR) Q4 2022 Earnings Call Transcript

REDWOOD CITY, CA / ACCESSWIRE / March 15, 2023 / 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, 2022. Fourth Quarter and Recent Highlights Fourth quarter revenue of $2.0 million, and gross margin of 34% Filed an FDA 510(k) submission for the new Pantheris LV (large vessel) device which brings important new features and benefits to Avinger's Pantheris family of image-guided atherectomy catheters Expanded penetration of Lightbox 3 next-generation imaging console with approximately 600 cases performed in more than 60 clinical sites since launch Advanced development program for first ever image-guided coronary CTO-crossing system and evaluated prototypes with expanded coronary clinical advisory board Continued enrollment in the Pantheris SV IMAGE-BTK clinical study (small vessel, below-the-knee), which continues to generate outstanding clinical outcomes data in a challenging patient population Maintained a strong cash position of $14.6 million at December 31, 2022 "We reported solid operating metrics in the fourth quarter, improving gross margin from the prior year on favorable product mix and driving efficiencies in our operating cost model as we advanced multiple product and clinical programs to position the company for future growth," commented Jeff Soinski, Avinger's President and CEO.

Avinger Reports Fourth Quarter 2022 Results

REDWOOD CITY, CA / ACCESSWIRE / March 2, 2023 / 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 vascular disease, today announced that it will release its financial results for the fourth quarter and full year 2022 after the close of trading on Wednesday, March 15, 2023. The Company will host a conference call beginning at 1:30 pm PT/4:30 pm ET.

Avinger to Announce Fourth Quarter 2022 Results on March 15

Pantheris LV Represents the Next-Generation of Onboard Image-Guided Technology for the Treatment of Peripheral Artery Disease REDWOOD CITY, CA / ACCESSWIRE / January 11, 2023 / 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 Company submitted a new 510(k) application to the U.S. Food & Drug Administration (FDA) for Pantheris LV, its next-generation image-guided atherectomy system for the treatment of larger vessels, such as the SFA and popliteal arteries, where the majority of PAD procedures are performed today. Pantheris LV offers multiple benefits to physician users, including higher speed plaque excision for efficient removal of challenging occlusive tissue and multiple features to streamline and simplify user-operation, including enhanced tissue packing and removal, a radiopaque gauge to measure volume of plaque removal during the procedure, and enhanced guidewire management.

Avinger Announces 510(k) Filing of Pantheris LV

Start Time: 16:30 January 1, 0000 4:50 PM ET Avinger, Inc (NASDAQ:AVGR ) Q3 2022 Earnings Conference Call November 09, 2022, 16:30 PM ET Company Participants Jeff Soinski - CEO Nabeel Subainati - Principal Financial Officer Matt Kreps - IR Conference Call Participants Operator Good afternoon, ladies and gentlemen, and welcome to the Avinger Third Quarter 2022 Results Call. At this time, all participants have been placed on a listen-only mode and the floor will be open for questions and comments after the presentation.

Avinger, Inc (AVGR) Q3 2022 Earnings Call Transcript

REDWOOD CITY, CA / ACCESSWIRE / November 9, 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 third quarter ended September 30, 2022. Third Quarter and Recent Highlights Third quarter revenue of $2.3 million, representing a 6% increase from the second quarter of 2022 Gross margin of 35%, with increased revenue and capital sales driving a 4-percentage point improvement from the second quarter Expanded penetration of Lightbox 3 next-generation imaging console with over 400 cases performed in more than 50 clinical sites since launch Completing development activities for Pantheris LV (large vessel), a line extension of Avinger's Pantheris family of image-guided atherectomy catheters, in preparation for 510(k) submission Advanced development of the first ever image-guided CTO-crossing device for the treatment of coronary artery disease (CAD), a new market for Avinger with existing reimbursement authorizations Continued enrollment in the IMAGE-BTK study for Pantheris SV (small vessel, below-the-knee) with preliminary data continuing to demonstrate outstanding clinical outcomes in a challenging patient population Increased cash position to $17.3 million at September 30, 2022, which includes proceeds from an equity financing completed in August 2022 "In the third quarter, we continued our progression of quarter-over-quarter improvement in revenue and gross margin, during what is typically a seasonally slower quarter," commented Jeff Soinski, Avinger's President and CEO.

Avinger Reports Third Quarter 2022 Results

REDWOOD CITY, CA / ACCESSWIRE / November 4, 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 announced the issuance of seven new U.S. and international patents in the second and third quarters of 2022 and provided an update on the expansion of its intellectual property portfolio. The seven new patents expand intellectual property protection for Avinger's proprietary image-guided atherectomy systems.

Avinger Announces Issuance of Seven New Patents Expanding Coverage for Its Proprietary Image-Guided Atherectomy Devices

REDWOOD CITY, CA / ACCESSWIRE / November 1, 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 vascular disease, today announced that it will release its financial results for the third quarter 2022 after the close of trading on Wednesday, November 9, 2022. The Company will host a conference call beginning at 1:30pm PT/4:30pm ET.

Avinger to Announce Third Quarter 2022 Results on November 9

REDWOOD CITY, CA / ACCESSWIRE / October 19, 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 announced that Chief Executive Officer Jeff Soinski will participate in the following investor conference event during October 2022. Event: LD Micro Main Event XV Date: Tuesday, October 25, 2022 Presentation: 10:00 a.m.

Avinger to Present at LD Micro Investor Conference

REDWOOD CITY, CA / ACCESSWIRE / September 1, 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 announced the presentation of interim data from the IMAGE-BTK clinical study for Pantheris SV at the annual AMP (Amputation Prevention Symposium) conference in August. AMP focuses on education and technologies for treating critical limb ischemia (CLI), an advanced stage of peripheral artery disease (PAD), in patients facing a life-altering amputation.

Interim Data from IMAGE-BTK Clinical Trial Presented at AMP 2022

Avinger, Inc. (NASDAQ:AVGR ) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Matt Kreps – Investor Relations Jeff Soinski – Chief Executive Officer Nabeel Subainati – Principal Financial Officer Conference Call Participants Operator Good day, everyone, and welcome to today's Avinger Second Quarter 2020 Results Call. [Operator Instructions] Please note, this call may be recorded.

Avinger, Inc.'s (AVGR) CEO Jeff Soinski on Q2 2022 Results - Earnings Call Transcript

REDWOOD CITY, CA / ACCESSWIRE / August 11, 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 second quarter ended June 30, 2022. Second Quarter and Recent Highlights Second quarter revenue of $2.1 million, representing a 13% increase from the first quarter of 2022 Gross margin of 31%, with increased revenue levels driving a 3 percentage point improvement from the first quarter Expanded to full commercial launch for the Lightbox 3 next-generation imaging console, which broadens market availability and brings a new mobile capability to the platform Filed a 510(k) application for the Company's new Tigereye ST image-guided crossing catheter for the treatment of chronic total occlusions (CTOs) in the peripheral arteries Made significant progress on the development of Pantheris LV (large vessel), a line extension of Avinger's Pantheris family of image-guided atherectomy catheters, anticipated to be the Company's next 510(k) submission Advanced development of the first ever image-guided CTO-crossing catheter for the treatment of coronary artery disease (CAD) Positive clinical data from the INSIGHT study for Pantheris (in-stent restenosis) and interim data from the IMAGE-BTK study for Pantheris SV (small vessel, below-the-knee) presented by key opinion leader physicians at clinical conferences in the US and Europe Maintained a strong cash position of $16.0 million at June 30, 2022, enhanced by the addition of $5.0 million in gross proceeds raised in August 2022 "During the second quarter, we made excellent progress against several important strategic initiatives and delivered solid sequential revenue growth," commented Jeff Soinski, Avinger's President and CEO.

Avinger Reports Second Quarter 2022 Results

REDWOOD CITY, CA / ACCESSWIRE / August 8, 2022 / Avinger, Inc. (NASDAQ:AVGR) (the "Company"), 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 announced the closing of its previously announced registered direct and private placement offerings priced at-the-market under Nasdaq rules, including the issuance and sale of (i) 700,000 shares of common stock and 784,019 pre-funded warrants in the registered direct offering and (ii) 1,369,864 pre-funded warrants in the private placement. The gross proceeds to Avinger from the offerings are approximately $5 million, before deducting placement agent fees and other offering expenses.

Avinger, Inc. Announces Closing of $5 Million Registered Direct and Private Placement Offerings Priced At-the-Market Under Nasdaq Rules

REDWOOD CITY, CA / ACCESSWIRE / August 5, 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 will release its financial results for the second quarter 2022 after the close of trading on Thursday, August 11, 2022. The Company will host a conference call beginning at 1:30pm PT/4:30pm ET.

Avinger to Announce Second Quarter 2022 Results on August 11

REDWOOD CITY, CA / ACCESSWIRE / August 4, 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 announced that it has entered into a definitive agreement with a single, healthcare-focused institutional investor for the sale and issuance of 1,484,019 shares of the Company's common stock (or pre-funded warrants in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules. Concurrently with the registered direct offering, the Company entered into a definitive agreement with the investor in the registered direct offering for the sale and issuance of 1,369,864 shares of common stock (or pre-funded warrants in lieu thereof) in a private placement priced at-the-market under Nasdaq rules.

Avinger Announces $5 Million Registered Direct and Private Placement Offerings, Priced At-the-Market Under Nasdaq Rules

REDWOOD CITY, CA / ACCESSWIRE / July 6, 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 company has submitted a 510(k) application to the U.S. Food & Drug Administration (FDA) for the Tigereye ST catheter, a next generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform. Tigereye ST is a next generation line extension of Avinger's Ocelot and Tigereye™ family of CTO crossing catheters.

Avinger Announces Filing of 510(k) Submission for Tigereye ST Image-Guided CTO Crossing System

REDWOOD CITY, CA / ACCESSWIRE / June 21, 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 its international presence with the commercial launch of its Lumivascular products in Chile. Avinger's new Lightbox 3 imaging console will be used exclusively to support the launch of the Lumivascular platform in Chile.

Avinger Expands International Presence with First Commercial Shipment to Chile

REDWOOD CITY, CA / ACCESSWIRE / June 15, 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 two podium presentations and a live case transmission featuring the company's Lumivascular technology at the Leipzig Interventional Course (LINC) 2022, which took place June 6 through June 9. LINC is a leading global forum for new methods and technology in the field of vascular medicine held each year in Leipzig, Germany.

Avinger Announces Presentations by Key Opinion Leaders and Live Case Transmission at LINC 2022

REDWOOD CITY, CA / ACCESSWIRE / June 6, 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 two podium presentations featuring the company's Lumivascular technology at the New Cardiovascular Horizons (NCVH) annual conference, which took place May 31 through June 3 in New Orleans. Key opinion leaders in the fields of interventional cardiology and endovascular interventions highlighted Avinger's Lumivascular technology in the following sessions: Dr. Ian Cawich, an interventional cardiologist and Director of the Vascular and Vein Institute at Arkansas Heart Hospital in Little Rock, highlighted the entire portfolio of Avinger's proprietary OCT-guided technologies, including the new Lightbox 3 imaging console, in his session, "OCT-Guidance for CTO Crossing and Atherectomy.

Avinger Announces Presentations by Key Opinion Leaders at New Cardiovascular Horizons Annual Conference

REDWOOD CITY, CA / ACCESSWIRE / May 16, 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 a key opinion leader (KOL) presentation and a live-case event featuring the Company's Lumivascular technology at two important vascular conferences in Germany: the annual CLI Congress on May 6-7 and Masterclass Münster on May 9-10. The annual CLI Congress in Germany is regarded as one of the foremost forums in the world addressing the complex condition of critical limb ischemia (CLI).

Avinger Announces Key Opinion Leader Presentation and Live Case at Vascular Conferences in Germany

Avinger, Inc. (NASDAQ:AVGR ) Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants Jeffery M. Soinski – Chief Executive Officer Mark Weinswig – Chief Financial Officer Matthew Kreps – Darrow Associates Investor Relations Conference Call Participants Marc Weisenberger – B.

Avinger, Inc. (AVGR) CEO Jeffery M. Soinski on Q1 2022 - Earnings Call Transcript

Avinger (AVGR) delivered earnings and revenue surprises of -92.56% and 0.11%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Avinger (AVGR) Reports Q1 Loss, Misses Revenue Estimates

REDWOOD CITY, CA / ACCESSWIRE / May 10, 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 first quarter ended March 31, 2022. Financial and Recent Highlights First quarter revenue of $1.9 million, compared with $2.6 million in the prior year first quarter, reflecting the impact of the Omicron variant surge and hospital staffing shortages on procedural volume in the first quarter Gross margin of 28%, related to lower revenue levels Received FDA 510(k) clearance for Lightbox 3 next-generation imaging console and successfully completed a limited launch program at select hospital centers Recently announced full U.S. commercial launch of Lightbox 3, designed to enhance the user experience and accelerate adoption at new hospital sites Progressed the development of two new catheter line extensions for peripheral artery disease (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 $20.0 million at March 31, 2022, enhanced by the addition of $7.6 million in gross proceeds raised in January 2022 Regained compliance with Nasdaq listing requirements "We are already seeing improved access and growing case volumes in the second quarter following the challenges from COVID-19 disruptions and hospital staffing shortages at the start of this year," commented Jeff Soinski, Avinger's President and CEO.

Avinger Reports First Quarter 2022 Results

REDWOOD CITY, CA / ACCESSWIRE / April 29, 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 first quarter 2022 after the close of trading on Tuesday, May 10, 2022. The Company will host a conference call beginning at 1:30pm PT/4:30pm ET.

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