Release Date: April 29, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q & A Highlights
Q: Can you discuss the balance between R&D expenses and SG&A, and how you're managing these aspects of the P&L for the rest of the year?
A: William Kelly, CFO, noted that the focus has been on building a quality robot and getting it to market as quickly as possible, aligning and prioritizing spending towards this goal. Despite a slight increase in the burn rate due to seasonal spending, the company remains committed to a $50 million cash burn for the year.
Q: What are the next steps after the completion of the V. 1.0 system in the fall, and how does this align with the planned clinical trial in mid to late 2025?
A: Adam Sachs, CEO, explained that after finalizing the V. 1.0 system and conducting preliminary verification and validation testing, the company will proceed to essential performance and safety testing. This will set the stage for starting the clinical trial in 2025.
Q: Can you provide more details on the spring cadaver lab, including the number of cadavers used, who performed the procedures, and the key learnings from this experience?
A: Adam Sachs mentioned that the lab involved a single cadaver and was conducted early in the spring to evaluate potential issues. The procedure was performed by internal U.S. surgeon research partners, focusing on testing the core functionality of the system and identifying necessary revisions.
Q: What specific refinements are needed for the final V. 1.0 system following the spring cadaver lab?
A: Adam Sachs highlighted several areas needing refinement, including software bugs and firmware issues within the arms, as well as interactions between the trocar seals and the arm. These issues are relatively straightforward to resolve, but there are several others that the team needs to address over the next few quarters.
Q: What are your early impressions of the company and the technology since joining, and how do you plan to influence the organization moving forward?
A: Randy Clark, President, expressed excitement about the dedication and talent within the company. He emphasized his commitment to disciplined execution and consistently achieving milestones to ensure the company's success.
Q: Can you update us on the plans for the OUS clinical trial to support the de novo submission and the process of establishing relationships with international sites?
A: Adam Sachs stated that while there are no new updates regarding FDA communications, the company is actively engaging with various international locations to maintain flexibility in site selection. This strategy allows them to adapt to changing regulatory environments and select the best sites closer to the trial's commencement.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
