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Sep 30, 2024
Avinger Q3 2024 Earnings Report
Reported improved productivity and increased gross margin due to lower operating cost profile.
Key Takeaways
Avinger reported Q3 2024 results with revenue of $1.7 million and a gross margin of 26%. The company implemented a cost reduction program, which led to a 15% improvement in net loss and a 12% improvement in adjusted EBITDA compared to the previous quarter. They also filed an IDE pre-submission package with the FDA for their coronary CTO-crossing system.
Reported third quarter 2024 revenue of $1.7 million, sequentially increased gross margin to 26%.
Implemented cost reduction program designed to streamline operating costs of the peripheral business and increase focus on coronary product development.
Filed Investigational Device Exemption (IDE) pre-submission package with the U.S. FDA in September for the company’s proprietary image-guided coronary CTO-crossing system.
Initiated full commercial launch of new Pantheris LV (large vessel) image-guided atherectomy device for use in the peripheral arteries.
Forward Guidance
Avinger anticipates submitting its IDE application in the fourth quarter, pending completion of the pre-submission process. Zylox is expected to complete its full manufacturing scale-up for Avinger's devices by mid-2025.
Positive Outlook
- The company is actively engaging with prospective clinical sites—five of which are already identified—and aim to expand to 10 or more sites before study initiation.
- Zylox recently received the prestigious Innovative Medical Device review designation for Pantheris in China, akin to the Breakthrough Device designation in the U.S.
- This recognition enables priority regulatory review and underscores the impact of our technology.
- Zylox's initial pre-market promotion activities are underway.
- Many physicians are already developing a strong interest in our image-guided technology.
Challenges Ahead
- Crossing chronic total occlusions (CTOs) in coronary arteries remains a major challenge for physicians, often involving complex, time-consuming and costly procedures with uncertain outcomes.
- The company is dependent on a limited number of products.
Historical Earnings Impact
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