For the six months ended June 30, 2023, revenue decreased by approximately $0.1 million or 2% compared to the six months ended June 30, 2022. Our revenues reflect the fluctuating demand partially due to the adverse impacts of hospital staffing shortages as capacity limitations in hospitals have limited the ability of practitioners to perform elective surgical procedures using our products in certain jurisdictions. In addition, we have experienced and expect that we will continue to experience attrition and ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2023 was $1.9 million, unchanged from Q1 2022 and down from $2 million in Q4 2022 [24] - Gross margin improved to 34% from 28% in the year-ago quarter, stable compared to Q4 2022 [24] - Operating expenses decreased to $4.9 million from $5.2 million in the year-ago quarter and increased from $4.5 million in Q4 2022 [24] - Net loss for Q1 2023 was $4.6 million, compared to $5.1 million in Q1 2022 and $4.2 million in Q4 2022 [24] - Adjusted EBITDA loss was $3.9 million, an improvement from a loss of $4.6 million in Q1 2022 and a loss of $3.8 million in Q4 2022 [25] - Cash and cash equivalents totaled $10.4 million at the end of the quarter [25] Business Line Data and Key Metrics Changes - Sales productivity improved by over 25%, achieving the same revenue with a lower sales headcount [8] - Pantheris SV small vessel atherectomy device showed significant growth in procedures and revenue compared to the prior year [13] Market Data and Key Metrics Changes - The company is expanding its clinical sales force, having added two new clinical specialists with more expected to join [9] Company Strategy and Development Direction - The company aims to increase case coverage and catheter utilization through the expansion and training of its clinical sales team [22] - Plans to launch two new peripheral products in the second half of 2023, which will broaden the product portfolio and create new usage drivers [22] - The development of a coronary product application is underway, targeting a market with significant potential [18][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recent Tigereye ST clearance and the anticipated Pantheris LV launch, which are expected to drive growth [26] - The company is focused on leveraging clinical data to enhance product adoption and market penetration [31] Other Important Information - The company received 510(k) clearance for the Tigereye ST catheter and initiated limited launch activities [6] - Pantheris LV is expected to receive FDA clearance in mid-2023, with a limited launch planned shortly thereafter [38] Q&A Session Summary Question: Update on ISR data and its impact on product adoption - Management noted that the ISR data has been powerful in enabling the sales force to market the device effectively, leading to increased adoption [30] Question: Status of Tigereye ST limited launch - The limited launch has commenced, with initial results expected soon, and full commercial availability anticipated in Q3 2023 [34] Question: Expectations for Pantheris LV product launch - The company is hopeful for timely FDA clearance and plans to initiate a limited launch in Q3 2023, with full commercial availability expected in Q4 2023 [39]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class: Trading Symbol(s): Name of each exchange on which registered: Common Stock, par value $0.001 per share AVGR The Nasdaq Capital Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36817 ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $2 million, down from $2.3 million in Q3 and $2.4 million in Q4 2021, primarily due to reduced sales headcount [21] - Gross margin for Q4 was 34%, stable compared to 35% in Q3 and up from 30% in the year-ago quarter, reflecting a favorable product mix and cost efficiencies [21] - Net loss for Q4 2022 was $4.2 million, relatively stable compared to $4.1 million in Q3 and improved by 16% from $5 million in Q4 2021 [22] Business Line Data and Key Metrics Changes - Pantheris image-guided atherectomy products showed growth, with both Pantheris 7 French and Pantheris SV devices each growing 6% sequentially [8] - The Pantheris SV device is now the largest selling product, primarily used for treating below-the-knee lesions [9][10] Market Data and Key Metrics Changes - CMS increased outpatient reimbursement in hospitals by 4% to 5% while decreasing atherectomy reimbursement in Office Based Labs by approximately 6%, which is seen as a net positive for the company since 90% of revenue comes from hospital accounts [9] Company Strategy and Development Direction - The company launched the Lightbox 3 imaging platform, enhancing capabilities and efficiency in engaging with accounts [6] - Plans for 2023 include launching two new products: Tigereye ST for CTO crossing and Pantheris LV for atherectomy, which are expected to expand the addressable market [15][19] - The company is focused on increasing case coverage capability, driving new account activity, and completing regulatory approvals for new devices [19] Management's Comments on Operating Environment and Future Outlook - Management noted that while the direct impact of COVID has lessened, staffing shortages continue to affect procedure availability [8] - The company is optimistic about the potential of its proprietary OCT-guided approach to revolutionize the coronary market [7][16] Other Important Information - Cash and cash equivalents totaled $14.6 million as of December 31, indicating a strong financial position to fund strategic initiatives [22] - The company is conducting a post-market clinical study called Image BTK to evaluate Pantheris SV, with promising interim results [11][12] Q&A Session Summary Question: Confidence in approval of Tigereye ST and Pantheris LV - Management expressed confidence in nearing the end of the review process for Tigereye ST and anticipates clearance by mid-year for Pantheris LV, pending FDA review [25] Question: Commercialization strategy for new products - Both products will undergo a limited launch to gain clinical experience and support for physicians before a full commercial launch [27] Question: Learnings from Lightbox 3 usage - The new Lightbox 3 has accelerated new account acquisition and has been well-received by existing physicians due to its advanced imaging capabilities [29] Question: Timeline for starting clinical programs for coronary CTO product - The goal is to initiate clinical studies in 2024, following the completion of design selection and verification processes [31]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36817 AVINGER, INC. (Exact name of registrant as specified in its charter) Delaware 20-8873453 (State or other jurisdiction of (I.R.S. Employer incorporation or organ ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $2.3 million, an increase from $2.1 million in Q2 2022, driven by increased capital sales [36] - Gross margin for Q3 2022 was 35%, a 4 percentage point increase from 31% in Q2 2022, reflecting higher revenue levels and a shift in product mix [37] - Operating expenses for Q3 2022 were $4.5 million, slightly up from $4.4 million in Q2 2022, indicating tight control over expenses while advancing strategic initiatives [38] - Net loss for Q3 2022 was $4.1 million, an improvement from $4.2 million in Q2 2022 [38] - Adjusted EBITDA for Q3 2022 was a loss of $3.6 million, an improvement from a loss of $3.7 million in Q2 2022 [39] - Cash and cash equivalents totaled $17.3 million as of September 30, 2022, bolstered by $5 million raised in August [40] Business Line Data and Key Metrics Changes - Capital sales were a significant contributor to revenue growth in Q3 2022, supported by the launch of the Lightbox 3 imaging console [10] - The Pantheris SV small vessel atherectomy device showed strong market performance, particularly in treating below-the-knee lesions [11] Market Data and Key Metrics Changes - The company is making progress in the enrollment of the IMAGE-BTK post-market study, with expectations to enroll up to 60 patients [13] - Interim findings from the IMAGE-BTK study showed a 90% reduction in percent stenosis and zero complications within 30 days post-procedure [14] Company Strategy and Development Direction - The company is focused on expanding its technology platform and peripheral product portfolio, with plans for new product launches in 2023 [9][24] - The development of the first coronary product application aims to redefine the treatment of coronary artery disease, targeting a large addressable market [26][34] - Strategic areas for growth include increasing case volume, expanding the user base through the Lightbox 3 console, and advancing new peripheral devices through regulatory approval [33] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding progress in Q3 2022, while acknowledging potential challenges from hospital staffing and respiratory virus infections [36] - The company is excited about the upcoming launches of new devices and the potential to transform the treatment landscape for vascular diseases [35][41] Other Important Information - The company plans to prioritize R&D efforts on the coronary program in 2023, aiming for an investigational device exemption filing [32] Q&A Session Summary Question: Are there any questions from institutional investors? - There were no questions in the queue during the Q&A session [42]

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. [Operator Instructions] It is now my pleasure to turn the program over to Matt Kreps, Investor Rel ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $1.9 million, reflecting a decrease due to hospital staffing challenges and access limitations [22] - Gross margin for Q1 2022 was 28%, with expectations for improvement as revenue grows [22] - Net loss for Q1 2022 was $5.1 million, flat compared to Q1 2021 [22] - Adjusted EBITDA for Q1 2022 was a loss of $4.6 million, compared to a loss of $4 million in Q1 2021 [23] - Cash and cash equivalents totaled $20 million as of March 31, 2022, following a fundraising of $7.6 million in January 2022 [23][24] Business Line Data and Key Metrics Changes - The launch of the Lightbox 3 imaging console has seen positive reviews and increased customer activity, contributing to improved procedural volume starting in March 2022 [6][8] - The company is developing two new catheter line extensions for its peripheral product portfolio, expected to broaden appeal and drive growth [10][12] Market Data and Key Metrics Changes - The company has identified a significant opportunity in the coronary artery disease market, with approximately 50,000 CTO PCI procedures performed annually in the U.S. [15][41] - The coronary market is seen as a transformational value opportunity due to its large addressable market and existing reimbursement profile [14][42] Company Strategy and Development Direction - Avinger aims to expand market penetration through the new Lightbox 3 and the development of innovative products for both peripheral and coronary applications [20][25] - The company is focused on leveraging its proprietary image-guided platform to address challenges in the coronary artery disease market [14][42] Management's Comments on Operating Environment and Future Outlook - Management noted a challenging hospital environment in Q1 2022 due to COVID-19 and staffing shortages, but expressed optimism about improving procedural volumes in Q2 2022 [6][30] - The company anticipates continued growth in procedural volumes and is encouraged by the recent commercial launch of the Lightbox 3 [20][30] Other Important Information - Mark Weinswig, the Chief Financial Officer, announced his resignation effective at the end of the week, initiating a search for a new CFO [20] - The company executed a reverse stock split in March 2022 to regain compliance with NASDAQ minimum bid rules [23] Q&A Session Summary Question: What caused the lower procedure volumes in the quarter? - Management indicated that both the Omicron variant surge and hospital staffing challenges contributed to the lower procedure volumes [28] Question: What is the current trend in procedure volumes? - Management reported a steady increase in procedural volume starting in March and continuing into May, with optimism for further growth [30] Question: How does the Lightbox 3 impact clinical staff utilization? - The portability of the Lightbox 3 has allowed for quicker engagement with new accounts and increased case volumes, demonstrating its effectiveness [32][34] Question: Were there any changes in the types of procedures performed? - Management noted a return to a more typical mix of procedures as elective procedures opened up, with an increase in SFA and popliteal cases [36] Question: What potential does the company see in the coronary artery disease market? - Management expressed excitement about the opportunity to make CTO PCI procedures more accessible and efficient, potentially reducing the need for invasive CABG procedures [41][42]