Vicarious Surgical Inc. (NYSE:RBOT) Q1 2024 Earnings Call Transcript

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Josh Jennings: Hi. Good afternoon. Thanks a lot for taking the questions. I wanted to just get an update on the plans for the OUS clinical trial to support the de novo submission. Any — I know it’s only been two months since the last call and the last update and less than that since our healthcare conference, but any further communications with the FDA on that trial design? And just, I guess, the second part of the question is thinking about international sites and how do you go about, I know we’re not until next year, but how do you go about establishing those relationships or maybe they’re already in hand in terms of finding investigator sites and finding the right ones and developing those surgeon relationships or center relationships with vicarious.

Adam Sachs: Yeah. Thanks, Josh, and two great questions there. So, I’ll start with the FDA side. So nothing that we have to share on that front directly, but what I will say is, as we’re seeing the broader robotics space continue to develop, we are seeing other filings and frankly other approvals come through, many of which are occurring with entirely outside the U.S. data, as well as with about 30 patients each in each trial. So this is further confirming that unsurprisingly the guidance and support that the FDA is giving to us is being given in exactly the same way to the other new entrants in the space and they are following through on their commitments there. So that is very reassuring for us to see. As far as specific site selection and country selection, we are in conversations with a number of different locations.

We do have time, but we are well on the way to working through this already, and one of the goals here is to maintain optionality for as long as we can. We actually view that as a distinct advantage, especially when frankly regulatory environments in specific countries do change and we’d like to maintain that optionality to choose the specific sites and even the specific countries out of a few that we’re working with at the latest point that wouldn’t impact our schedule.

Josh Jennings: Great. And then just to follow up on the cadaveric testing results and some of the refinements that you’re going to put in play, is there — are there more cadaveric lab sessions that are required before you get to that fully integrate — fully integrated, I guess, era and move forward with the pre-V&V testing? Thanks for taking all the questions.

Adam Sachs: Yeah. So the answer to that is certainly yes. We’re well on the way to implementing a lot of these refinements already and they’re being primarily implemented into this next build, which will then be tested through robust cadaveric testing, as well as a number of other tests.

Josh Jennings: Great. Thank you.

Operator: Ladies and gentlemen, this concludes our Q&A and today’s conference call. We’d like to thank you for your participation. You may now disconnect your lines.

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