Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What feedback have you received from physicians regarding the Pantheris LV, and how do you foresee its future adoption? A: Jeffrey Soinski, CEO: The response to the Pantheris LV has been positive, with physicians appreciating its simplicity and ease of use. The device was designed to streamline procedures and is showing early success in the market. Despite being in the early stages of full commercial launch, Pantheris LV revenue increased by over 20% compared to the previous quarter.
Q: How confident are you in Zylox's ability to obtain regulatory approval in China, and what additional steps are needed for commercialization? A: Jeffrey Soinski, CEO: We are confident in Zylox's progress, having completed rigorous type testing and several regulatory filings. We anticipate regulatory approval in China by the second half of 2025. Zylox is also developing manufacturing capabilities, expected to be ready by mid-2025, which will help reduce costs and support market entry.
Q: Can you elaborate on the strategic realignment and its impact on financial performance? A: Nabeel Subainati, CFO: The strategic realignment included a 24% reduction in headcount, focusing on high-value accounts, and streamlining operations. This resulted in improved operating efficiency, with gross margins increasing to 26% and a reduction in operating expenses to $4.1 million in Q3 2024.
Q: What are the anticipated benefits of the coronary CTO crossing system, and what is the timeline for its development? A: Jeffrey Soinski, CEO: The coronary CTO crossing system aims to reduce procedure times and improve success rates using OCT guidance. We have completed phase three testing and submitted a pre-submission package to the FDA. We expect to file the IDE in the fourth quarter and begin patient enrollment in the first half of 2025.
Q: How does the partnership with Zylox-Tonbridge align with Avinger's strategic goals? A: Jeffrey Soinski, CEO: The partnership with Zylox provides market access to China, cost-effective manufacturing, and aligns investment interests. It supports our strategic goal of expanding into the Chinese market, which has a significant population affected by peripheral artery disease, and offers potential cost reductions through offshore manufacturing.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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