Avinger Q2 2023 Earnings Report
Key Takeaways
Avinger, Inc. reported second quarter 2023 results, featuring revenue of $2.0 million and a gross margin of 30%. The company received 510(k) clearance for Tigereye ST and Pantheris LV, and advanced the development of its coronary CTO-crossing system.
Second quarter revenue reached $2.0 million with a gross margin of 30%.
510(k) clearance was received and a limited launch initiated for Tigereye ST, with a full commercial launch expected in the third quarter.
510(k) clearance was received for the new Pantheris LV device, and a limited launch was initiated in the third quarter.
Development of the image-guided coronary CTO-crossing system advanced through successful animal studies, with further studies planned for the third quarter.
Avinger
Avinger
Forward Guidance
Avinger anticipates full commercial launch of Tigereye ST in Q3 2023 and Pantheris LV in Q4 2023, and expects to file an IDE application with the FDA in the first half of next year to allow for initiation of a clinical study in 2024.
Positive Outlook
- Advancing Tigereye ST CTO-crossing system to full commercial launch in the third quarter.
- Commencing a limited launch of the recently cleared Pantheris LV device.
- Potential for innovative devices to expand the addressable market for products.
- Documenting best-in-class clinical outcomes in challenging patient cases.
- Making substantive progress on the development of a coronary product application.
Challenges Ahead
- Dependency on a limited number of products.
- Resource requirements related to Pantheris, Tigereye and our Lightbox imaging console.
- Outcome of clinical trial results.
- Adoption of products by physicians.
- Ability to obtain regulatory approvals for products.