Avinger Q3 2024 Earnings Report
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.
Avinger
Avinger
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.
- Resource requirements related to Pantheris, Tigereye and our Lightbox imaging console.
- The outcome of clinical trial results is uncertain.
- The adoption of our products by physicians is uncertain.